Publications by authors named "Calum Roberts"

41 Publications

Oxygen saturation and heart rate in healthy term and late preterm infants with delayed cord clamping.

Pediatr Res 2022 Jan 7. Epub 2022 Jan 7.

Neonatal Research Group, Health Research Institute and University and Polytechnic Hospital La Fe, Valencia, Spain.

Blood oxygen in the fetus is substantially lower than in the newborn infant. In the minutes after birth, arterial oxygen saturation rises from around 50-60% to 90-95%. Initial respiratory efforts generate negative trans-thoracic pressures that drive liquid from the airways into the lung interstitium facilitating lung aeration, blood oxygenation, and pulmonary artery vasodilatation. Consequently, intra- (foramen ovale) and extra-cardiac (ductus arteriosus) shunting changes and the sequential circulation switches to a parallel pulmonary and systemic circulation. Delaying cord clamping preserves blood flow through the ascending vena cava, thus increasing right and left ventricular preload. Recently published reference ranges have suggested that delayed cord clamping positively influenced the fetal-to-neonatal transition. Oxygen saturation in babies with delayed cord clamping plateaus significantly earlier to values of 85-90% than in babies with immediate cord clamping. Delayed cord clamping may also contribute to fewer episodes of brady-or-tachycardia in the first minutes after birth, but data from randomized trials are awaited. IMPACT: Delaying cord clamping during fetal to neonatal transition contributes to a significantly earlier plateauing of oxygen saturation and fewer episodes of brady-and/or-tachycardia in the first minutes after birth. We provide updated information regarding the changes in SpO and HR during postnatal adaptation of term and late preterm infants receiving delayed compared with immediate cord clamping. Nomograms in newborn infants with delayed cord clamping will provide valuable reference ranges to establish target SpO and HR in the first minutes after birth.
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http://dx.doi.org/10.1038/s41390-021-01805-yDOI Listing
January 2022

Single versus continuous sustained inflations during chest compressions and physiological-based cord clamping in asystolic lambs.

Arch Dis Child Fetal Neonatal Ed 2021 Nov 29. Epub 2021 Nov 29.

Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia

Background: The feasibility and benefits of continuous sustained inflations (SIs) during chest compressions (CCs) during delayed cord clamping (physiological-based cord clamping; PBCC) are not known. We aimed to determine whether continuous SIs during CCs would reduce the time to return of spontaneous circulation (ROSC) and improve post-asphyxial blood pressures and flows in asystolic newborn lambs.

Methods: Fetal sheep were surgically instrumented immediately prior to delivery at ~139 days' gestation and asphyxia induced until lambs reached asystole. Lambs were randomised to either immediate cord clamping (ICC) or PBCC. Lambs then received a single SI (SI; 30 s at 30 cmHO) followed by intermittent positive pressure ventilation, or continuous SIs (SI: 30 s duration with 1 s break). We thus examined 4 groups: ICC +SI, ICC +SI, PBCC +SI, and PBCC +SI. Chest compressions and epinephrine administration followed international guidelines. PBCC lambs underwent cord clamping 10 min after ROSC. Physiological and oxygenation variables were measured throughout.

Results: The time taken to achieve ROSC was not different between groups (mean (SD) 4.3±2.9 min). Mean and diastolic blood pressure was higher during chest compressions in PBCC lambs compared with ICC lambs, but no effect of SIs was observed. SI significantly reduced pulmonary blood flow, diastolic blood pressure and oxygenation after ROSC compared with SI.

Conclusion: We found no significant benefit of SI over SI during CPR on the time to ROSC or on post-ROSC haemodynamics, but did demonstrate the feasibility of continuous SIs during advanced CPR on an intact umbilical cord. Longer-term studies are recommended before this technique is used routinely in clinical practice.
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http://dx.doi.org/10.1136/archdischild-2021-322881DOI Listing
November 2021

Introduction of a Quality Improvement Bundle Is Associated with Reduced Exposure to Mechanical Ventilation in Very Preterm Infants.

Neonatology 2021 1;118(5):578-585. Epub 2021 Sep 1.

Department of Paediatrics, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Victoria, Australia.

Introduction: Exposure to mechanical ventilation (MV) is a risk factor for bronchopulmonary dysplasia (BPD) in very preterm infants (VPTIs). We assessed the impact of a quality improvement (QI) bundle in VPTIs (<32 week gestation) on exposure to MV.

Methods: We introduced a QI bundle consisting of deferred cord clamping (DCC), nasal bubble continuous positive airway pressure (bCPAP) in the delivery room (DR), and minimally invasive surfactant therapy (MIST). We compared respiratory outcomes and neonatal morbidity in historical pre-QI (July-December 2017) and prospective post-QI (February-July 2019) cohorts (QICs) of VPTIs. We pre-specified an adjusted analysis to account for the effects of gestational age, sex, antenatal steroids, and any demographic data that significantly differed between cohorts.

Results: The pre-QI and post-QICs included 87 and 98 VPTIs, respectively. The post-QIC had decreased rates of MV in the DR (adjusted odds ratio [aOR] 0.26, 95% confidence interval [CI] 0.09-0.71), in the first 72 h of life (aOR 0.27, 95% CI 0.11-0.62) and during admission (aOR 0.28, 95% CI 0.12-0.66). Rates of BPD, combined BPD/death, and BPD severity were similar. The post-QIC was less likely to be discharged with home oxygen (aOR 0.27, 95% CI 0.08-0.91). Necrotising enterocolitis grade ≥2 increased (aOR 19.01, 95% CI 1.93-188.6) in the post-QIC.

Conclusion: In this rapid-cycle QI study, implementation of a QI bundle consisting of DCC, early nasal bCPAP, and MIST in VPTIs was associated with reduced rates of MV in the DR, in the first 72 h of life and during admission, and reduced need for home oxygen.
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http://dx.doi.org/10.1159/000518392DOI Listing
November 2021

Impact of early respiratory care for extremely preterm infants.

Semin Perinatol 2021 12 21;45(8):151478. Epub 2021 Aug 21.

Monash Newborn, Monash Children's Hospital, Monash University, Clayton, VIC, Australia; Department of Paediatrics, Monash University, Clayton, VIC, Australia; The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.

Despite advances in neonatal intensive care, more than half of surviving infants born extremely preterm (EP; < 28 weeks' gestation) develop bronchopulmonary dysplasia (BPD). Prevention of BPD is critical because of its associated mortality and morbidity, including adverse neurodevelopmental outcomes and respiratory health in later childhood and beyond. The respiratory care of EP infants begins before birth, then continues in the delivery room and throughout the primary hospitalization. This chapter will review the evidence for interventions after birth that might improve outcomes for infants born EP, including the timing of umbilical cord clamping, strategies to avoid or minimize exposure to mechanical ventilation, modes of mechanical ventilation and non-invasive respiratory support, oxygen saturation targets, postnatal corticosteroids and other adjunct therapies.
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http://dx.doi.org/10.1016/j.semperi.2021.151478DOI Listing
December 2021

Comparison of intraosseous and intravenous epinephrine administration during resuscitation of asphyxiated newborn lambs.

Arch Dis Child Fetal Neonatal Ed 2021 Aug 30. Epub 2021 Aug 30.

The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia.

Objective: Intraosseous access is recommended as a reasonable alternative for vascular access during newborn resuscitation if umbilical access is unavailable, but there are minimal reported data in newborns. We compared intraosseous with intravenous epinephrine administration during resuscitation of severely asphyxiated lambs at birth.

Methods: Near-term lambs (139 days' gestation) were instrumented antenatally for measurement of carotid and pulmonary blood flow and systemic blood pressure. Intrapartum asphyxia was induced by umbilical cord clamping until asystole. Resuscitation commenced with positive pressure ventilation followed by chest compressions and the lambs received either intraosseous or central intravenous epinephrine (10 μg/kg); epinephrine administration was repeated every 3 min until return of spontaneous circulation (ROSC). The lambs were maintained for 30 min after ROSC. Plasma epinephrine levels were measured before cord clamping, at end asphyxia, and at 3 and 15 min post-ROSC.

Results: ROSC was successful in 7 of 9 intraosseous epinephrine lambs and in 10 of 12 intravenous epinephrine lambs. The time and number of epinephrine doses required to achieve ROSC were similar between the groups, as were the achieved plasma epinephrine levels. Lambs in both groups displayed a similar marked overshoot in systemic blood pressure and carotid blood flow after ROSC. Blood gas parameters improved more quickly in the intraosseous lambs in the first 3 min, but were otherwise similar over the 30 min after ROSC.

Conclusions: Intraosseous epinephrine administration results in similar outcomes to intravenous epinephrine during resuscitation of asphyxiated newborn lambs. These findings support the inclusion of intraosseous access as a route for epinephrine administration in current guidelines.
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http://dx.doi.org/10.1136/archdischild-2021-322638DOI Listing
August 2021

Effect of maternal oxytocin on umbilical venous and arterial blood flows during physiological-based cord clamping in preterm lambs.

PLoS One 2021 17;16(6):e0253306. Epub 2021 Jun 17.

The Ritchie Centre, Hudson Institute of Medical Research, Melbourne, Australia.

Background: Delayed umbilical cord clamping (UCC) after birth is thought to cause placental to infant blood transfusion, but the mechanisms are unknown. It has been suggested that uterine contractions force blood out of the placenta and into the infant during delayed cord clamping. We have investigated the effect of uterine contractions, induced by maternal oxytocin administration, on umbilical artery (UA) and venous (UV) blood flows before and after ventilation onset to determine whether uterine contractions cause placental transfusion in preterm lambs.

Methods And Findings: At ~128 days of gestation, UA and UV blood flows, pulmonary arterial blood flow (PBF) and carotid arterial (CA) pressures and blood flows were measured in three groups of fetal sheep during delayed UCC; maternal oxytocin following mifepristone, mifepristone alone, and saline controls. Each successive uterine contraction significantly (p<0.05) decreased UV (26.2±6.0 to 14.1±4.5 mL.min-1.kg-1) and UA (41.2±6.3 to 20.7 ± 4.0 mL.min-1.kg-1) flows and increased CA pressure and flow (47.1±3.4 to 52.8±3.5 mmHg and 29.4±2.6 to 37.3±3.4 mL.min-1.kg-1). These flows and pressures were partially restored between contractions, but did not return to pre-oxytocin administration levels. Ventilation onset during DCC increased the effects of uterine contractions on UA and UV flows, with retrograde UA flow (away from the placenta) commonly occurring during diastole.

Conclusions: We found no evidence that amplification of uterine contractions with oxytocin increase placental transfusion during DCC. Instead they decreased both UA and UV flow and caused a net loss of blood from the lamb. Uterine contractions did, however, have significant cardiovascular effects and reduced systemic and cerebral oxygenation.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0253306PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8211207PMC
November 2021

Nucleated Red Blood Cells as Markers of Perinatal Adaptation in Preterm Neonates Receiving Minimally Invasive Surfactant Therapy.

Am J Perinatol 2021 Mar 23. Epub 2021 Mar 23.

Monash Newborn, Monash Children's Hospital, Melbourne, Australia.

Objective:  The study aimed to assess the association of nucleated red blood cells (NRBC), a surrogate of intrauterine hypoxia, and elevated pulmonic vascular resistance (E-PVR) and oxygen requirement after minimally invasive surfactant therapy (MIST).

Study Design:  Retrospective study of a cohort of preterm neonates that received MIST in a single unit.

Results:  NRBC were measured in 65 of 75 (87%) neonates administered MIST during the period. In total, 22 of 65 (34%) infants had pre-MIST echocardiography (ECHO).Neonates with elevated NRBC (predefined as >5 × 10/L,  = 16) required higher post-MIST fraction of inspired oxygen (FiO) than neonates with normal NRBC (<1 × 10/L,  = 17; FiO= 0.31 ± 0.10 and 0.24 ± 0.04, respectively,  = 0.02).NRBC correlated positively with % of time in right to left ductal shunt (r = 0.51,  = 0.052) and inversely with right ventricular stroke volume (r = -0.55,  = 0.031) and time to peak velocity to right ventricular ejection time ratio (r = -0.62,  < 0.001).

Conclusion:  Elevated NRBC are associated with elevated FiO after MIST and elevated E-PVR. Intrauterine hypoxia may impact postnatal circulatory adaptations and oxygen requirement.

Key Points: · Post-MIST FiO2 requirements are significantly higher in infants with elevated NRBC.. · NRBC correlates positively with elevated PVR in neonates requiring.. · Intrauterine hypoxia may play a role in postnatal circulatory adaptations in neonates with RDS..
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http://dx.doi.org/10.1055/s-0041-1726317DOI Listing
March 2021

High-CPAP Does Not Impede Cardiovascular Changes at Birth in Preterm Sheep.

Front Pediatr 2020 22;8:584138. Epub 2021 Jan 22.

The Ritchie Centre, Hudson Institute of Medical Research, Melbourne, VIC, Australia.

Continuous positive airway pressures (CPAP) used to assist preterm infants at birth are limited to 4-8 cmHO due to concerns that high-CPAP may cause pulmonary overexpansion and adversely affect the cardiovascular system. We investigated the effects of high-CPAP on pulmonary (PBF) and cerebral (CBF) blood flows and jugular vein pressure (JVP) after birth in preterm lambs. Preterm lambs instrumented with flow probes and catheters were delivered at 133/146 days gestation. Lambs received low-CPAP (LCPAP: 5 cmHO), high-CPAP (HCPAP: 15 cmHO) or dynamic HCPAP (15 decreasing to 8 cmHO at ~2 cmHO/min) for up to 30 min after birth. Mean PBF was lower in the LCPAP [median (Q1-Q3); 202 (48-277) mL/min, = 0.002] compared to HCPAP [315 (221-365) mL/min] and dynamic HCPAP [327 (269-376) mL/min] lambs. CBF was similar in LCPAP [65 (37-78) mL/min], HCPAP [73 (41-106) mL/min], and dynamic HCPAP [66 (52-81) mL/min, = 0.174] lambs. JVP was similar at CPAPs of 5 [8.0 (5.1-12.4) mmHg], 8 [9.4 (5.3-13.4) mmHg], and 15 cmHO [8.6 (6.9-10.5) mmHg, = 0.909]. Heart rate was lower in the LCPAP [134 (101-174) bpm; = 0.028] compared to the HCPAP [173 (139-205)] and dynamic HCPAP [188 (161-207) bpm] groups. Ventilation or additional caffeine was required in 5/6 LCPAP, 1/6 HCPAP, and 5/7 dynamic HCPAP lambs ( = 0.082), whereas 3/6 LCPAP, but no HCPAP lambs required intubation ( = 0.041), and 1/6 LCPAP, but no HCPAP lambs developed a pneumothorax ( = 0.632). High-CPAP did not impede the increase in PBF at birth and supported preterm lambs without affecting CBF and JVP.
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http://dx.doi.org/10.3389/fped.2020.584138DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7862825PMC
January 2021

Assessing pulmonary circulation in severe bronchopulmonary dysplasia using functional echocardiography.

Physiol Rep 2021 01;9(1):e14690

The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC., Australia.

Pulmonary hypertension (PH) is common in infants with severe bronchopulmonary dysplasia (BPD) and increases the risk of death. The objectives of this preliminary study were to compare responses of pulmonary circulation parameters to 100% oxygen (O ) and inhaled nitric oxide (iNO) in infants with BPD and PH using echocardiography. Responses between fetal growth restriction (FGR) and appropriate for gestational age infants were compared. Ten infants <28 weeks GA at birth were assessed at ≥36 weeks corrected gestation. Baseline echocardiography1 was performed which was repeated (echocardiography2) after 30 minutes of O . After a gap of 2-3 hours, iNO was administered for 15 minutes and echocardiography3 was performed, followed by iNO weaning. The gestation and birthweight of the cohort were 25.9 ± 1.6 weeks and 612 ± 175 g. Assessments were performed at 38.7 ± 1.4 weeks corrected gestational age. Baseline time to peak velocity: right ventricular ejection time (TPV/RVETc) increased from 0.24 ± 0.02 to 0.27 ± 0.02 (O , p = .01) and 0.31 ± 0.03 (iNO, p < .001), indicating a decrease in pulmonary vascular resistance [PVR]. Baseline tricuspid annular plane systolic excursion (TAPSE) increased from 8.1 ± 0.6 mm to 9.3 ± 0.7 mm (O , p = .01) and 10.5 ± 1.1 mm (iNO, p = .0004), indicating improved ventricular systolic performance. Percentage change for all parameters was greater with iNO. Significant correlations between cardiac performance and PVR were noted. FGR infants noted higher baseline PVR (TPV/RVETc, 0.21 ± 0.02 vs. 0.25 ± 0.01, p = .002), lower ventricular performance (TAPSE, 7 ± 1.2 mm vs. 8.6 ± 6 mm, p = .003), and lower percentage change with O and iNO. A reactive component of pulmonary circulation provides real-time physiological information, which could rationalize treatment decisions.
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http://dx.doi.org/10.14814/phy2.14690DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7785052PMC
January 2021

Outcomes after Introduction of Minimally Invasive Surfactant Therapy in Two Australian Tertiary Neonatal Units.

J Pediatr 2021 02 14;229:141-146. Epub 2020 Oct 14.

Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia.

Objective: To assess the procedural and clinical outcomes associated with the introduction of minimally invasive surfactant therapy (MIST) into standard care at 2 tertiary Australian neonatal intensive care units.

Study Design: A prospective audit was designed before the introduction of MIST in 2018, with data collected over a period of 18 months. Procedural data were completed by the clinical team performing MIST, including clinical observations, medication use, and adverse events. The audit team collected demographic data and subsequent clinical outcomes from medical records.

Results: There were 135 MIST procedures recorded in 122 infants. For the included infants, the median gestation was 30 weeks (IQR, 27 to 32 weeks) and birth weight was 1439 g (IQR, 982-1958 g). During the MIST procedure, desaturation to a peripheral oxygen saturation of <80% was common, occurring in 75.2% of procedures. Other adverse events included need for positive pressure ventilation (10.6%) and bradycardia <100 beats per minute (13.3%). The use of atropine premedication was associated with a significantly lower incidence of bradycardia: 8.6% vs 52.9% (P < .01). Senior clinicians demonstrated higher rates of procedural success. The majority of infants (63.9%) treated with MIST did not require subsequent intubation and mechanical ventilation.

Conclusions: MIST can be successfully introduced in neonatal units with limited experience of this technique. The use of atropine premedication decreases the incidence of bradycardia during the procedure. Success rates can be optimized by limiting MIST to clinicians with greater competence in endotracheal intubation.
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http://dx.doi.org/10.1016/j.jpeds.2020.10.025DOI Listing
February 2021

Excess cerebral oxygen delivery follows return of spontaneous circulation in near-term asphyxiated lambs.

Sci Rep 2020 10 5;10(1):16443. Epub 2020 Oct 5.

The Ritchie Centre, The Hudson Institute of Medical Research, 27-31 Wright St, Clayton, VIC, 3168, Australia.

Hypoxic-ischaemia renders the neonatal brain susceptible to early secondary injury from oxidative stress and impaired autoregulation. We aimed to describe cerebral oxygen kinetics and haemodynamics immediately following return of spontaneous circulation (ROSC) and evaluate non-invasive parameters to facilitate bedside monitoring. Near-term sheep fetuses [139 ± 2 (SD) days gestation, n = 16] were instrumented to measure carotid artery (CA) flow, pressure, right brachial arterial and jugular venous saturation (SaO and SvO, respectively). Cerebral oxygenation (crSO) was measured using near-infrared spectroscopy (NIRS). Following induction of severe asphyxia, lambs received cardiopulmonary resuscitation using 100% oxygen until ROSC, with oxygen subsequently weaned according to saturation nomograms as per current guidelines. We found that oxygen consumption did not rise following ROSC, but oxygen delivery was markedly elevated until 15 min after ROSC. CrSO and heart rate each correlated with oxygen delivery. SaO remained > 90% and was less useful for identifying trends in oxygen delivery. CrSO correlated inversely with cerebral fractional oxygen extraction. In conclusion, ROSC from perinatal asphyxia is characterised by excess oxygen delivery that is driven by rapid increases in cerebrovascular pressure, flow, and oxygen saturation, and may be monitored non-invasively. Further work to describe and limit injury mediated by oxygen toxicity following ROSC is warranted.
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http://dx.doi.org/10.1038/s41598-020-73453-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7536421PMC
October 2020

A multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation (the SHINE trial): a study protocol.

BMJ Open 2020 10 5;10(10):e039230. Epub 2020 Oct 5.

Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia.

Introduction: Neonatal endotracheal intubation is an essential but potentially destabilising procedure. With an increased focus on avoiding mechanical ventilation, particularly in preterm infants, there are fewer opportunities for clinicians to gain proficiency in this important emergency skill. Rates of successful intubation at the first attempt are relatively low, and adverse event rates are high, when compared with intubations in paediatric and adult populations. Interventions to improve operator success and patient stability during neonatal endotracheal intubations are needed. Using nasal high flow therapy extends the safe apnoea time of adults undergoing upper airway surgery and during endotracheal intubation. This technique is untested in neonates.

Methods And Analysis: The tabilisation with nasal igh flow during ntubation of onates (SHINE) trial is a multicentre, randomised controlled trial comparing the use of nasal high flow during neonatal intubation with standard care (no nasal high flow). Intubations are randomised individually, and stratified by site, use of premedications, and postmenstrual age (<28 weeks' gestation; ≥28 weeks' gestation). The primary outcome is the incidence of successful intubation on the first attempt without physiological instability of the infant. Physiological instability is defined as an absolute decrease in peripheral oxygen saturation >20% from preintubation baseline and/or bradycardia (<100 beats per minute).

Ethics And Dissemination: The SHINE trial received ethical approval from the Human Research Ethics Committees of The Royal Women's Hospital, Melbourne, Australia and Monash Health, Melbourne, Australia. The trial is currently recruiting in these two sites. The findings of this study will be disseminated via peer-reviewed journals and presented at national and international conferences.

Trial Registration Number: ACTRN12618001498280.
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http://dx.doi.org/10.1136/bmjopen-2020-039230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537449PMC
October 2020

Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review.

Arch Dis Child Fetal Neonatal Ed 2021 May 28;106(3):336-341. Epub 2020 Sep 28.

Women, Children and Families, Central Coast Local Health District, Gosford, New South Wales, Australia.

Surfactant is an effective treatment for respiratory distress syndrome, being particularly important for infants in whom continuous positive airway pressure (CPAP) provides insufficient support. Supraglottic airway devices present an attractive option for surfactant delivery, particularly as an alternative to methods dependent on direct laryngoscopy, a procedural skill that is both difficult to learn and in which to maintain competence. Published studies provide encouraging data that surfactant administration by supraglottic airway device can be performed with a high rate of success and may reduce the need for subsequent intubation compared with either continued CPAP or surfactant administration via endotracheal tube. However, existing randomised controlled trials (RCTs) are heterogeneous in design and include just over 350 infants in total. To date, all RCT evidence has been generated in tertiary units, whereas the greatest potential for benefit from the use of these devices is likely to be in non-tertiary settings. Future research should investigate choice and utility of device in addition to safety and effectiveness of procedure. Importantly, studies conducted in non-tertiary settings should evaluate feasibility, meaningful clinical outcomes and the impact that this approach might have on infants and their families. Supraglottic airway devices may represent a simple and effective mode of surfactant administration that can be widely used by a variety of clinicians. However, further well-designed RCTs are required to determine their role, safety and effectiveness in both tertiary and non-tertiary settings before introduction into routine clinical practice.
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http://dx.doi.org/10.1136/archdischild-2020-319804DOI Listing
May 2021

Inherent device: Are neonatologists cool with the face mask for resuscitation at birth, or is further investigation required?

Authors:
Calum T Roberts

Resuscitation 2020 11 30;156:270-272. Epub 2020 Sep 30.

Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia; Department of Paediatrics, Monash University, Clayton, Victoria, Australia; The Ritchie Centre, Hudson Institute of Medical Research, Clayton, Victoria, Australia. Electronic address:

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http://dx.doi.org/10.1016/j.resuscitation.2020.09.024DOI Listing
November 2020

Cardiopulmonary Resuscitation of Asystolic Newborn Lambs Prior to Umbilical Cord Clamping; the Timing of Cord Clamping Matters!

Front Physiol 2020 30;11:902. Epub 2020 Jul 30.

The Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.

Current guidelines recommend immediate umbilical cord clamping (UCC) for newborns requiring chest compressions (CCs). Physiological-based cord clamping (PBCC), defined as delaying UCC until after lung aeration, has advantages over immediate UCC in mildly asphyxiated newborns, but its efficacy in asystolic newborns requiring CC is unknown. The aim of this study was to compare the cardiovascular response to CCs given prior to or after UCC in asystolic near-term lambs. Umbilical, carotid, pulmonary, and femoral arterial flows and pressures as well as systemic and cerebral oxygenation were measured in near-term sheep fetuses [139 ± 2 (SD) days gestation]. Fetal asphyxia was induced until asystole ensued, whereupon lambs received ventilation and CC before (PBCC; = 16) or after ( = 12) UCC. Epinephrine was administered 1 min after ventilation onset and in 3-min intervals thereafter. The PBCC group was further separated into UCC at either 1 min (PBCC, = 8) or 10 min (PBCC, = 8) after return of spontaneous circulation (ROSC). Lambs were maintained for a further 30 min after ROSC. The duration of CCs received and number of epinephrine doses required to obtain ROSC were similar between groups. After ROSC, we found no physiological benefits if UCC was delayed for 1 min compared to immediate cord clamping (ICC). However, if UCC was delayed for 10 min after ROSC, we found significant reductions in post-asphyxial rebound hypertension, cerebral blood flow, and cerebral oxygenation. The prevention of the post-asphyxial rebound hypertension in the PBCC group occurred due to the contribution of the placental circulation to a low peripheral resistance. As a result, left and right ventricular outputs continued to perfuse the placenta and were evidenced by reduced mean pulmonary blood flow, persistence of right-to-left shunting across the ductus arteriosus, and persistence of umbilical arterial and venous blood flows. It is possible to obtain ROSC after CC while the umbilical cord remains intact. There were no adverse effects of PBCC compared to ICC; however, the physiological changes observed after ROSC in the ICC and early PBCC groups may result in additional cerebral injury. Prolonging UCC after ROSC may provide significant physiological benefits that may reduce the risk of harm to the cerebral circulation.
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http://dx.doi.org/10.3389/fphys.2020.00902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7406709PMC
July 2020

Predicting Nasal High-Flow Treatment Success in Newborn Infants with Respiratory Distress Cared for in Nontertiary Hospitals.

J Pediatr 2020 12 15;227:135-141.e1. Epub 2020 Jul 15.

Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Parkville, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Parkville, Victoria, Australia. Electronic address:

Objective: To evaluate demographic and clinical variables as predictors of nasal high-flow treatment success in newborn infants with respiratory distress cared for in Australian nontertiary special care nurseries.

Study Design: A secondary analysis of the HUNTER trial, a multicenter, randomized controlled trial evaluating nasal high-flow as primary respiratory support for newborn infants with respiratory distress who were born ≥31 weeks of gestation and with birth weight ≥1200 g, and cared for in Australian nontertiary special care nurseries. Treatment success within 72 hours after randomization to nasal high-flow was determined using objective criteria. Univariable screening and multivariable analysis was used to determine predictors of nasal high-flow treatment success.

Results: Infants (n = 363) randomized to nasal high-flow in HUNTER were included in the analysis; the mean gestational age was 36.9 ± 2.7 weeks and birth weight 2928 ± 782 g. Of these infants, 290 (80%) experienced nasal high-flow treatment success. On multivariable analysis, nasal high-flow treatment success was predicted by higher gestational age and lower fraction of inspired oxygen immediately before randomization, but not strongly. The final model was found to have an area under the curve of 0.65, which after adjustment for optimism was found to be 0.63 (95% CI, 0.57-0.70).

Conclusions: Gestational age and supplemental oxygen requirement may be used to guide decisions regarding the most appropriate initial respiratory support for newborn infants in nontertiary special care nurseries. Further prospective research is required to better identify which infants are most likely to be successfully treated with nasal high-flow.

Trial Registration: ACTRN12614001203640.
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http://dx.doi.org/10.1016/j.jpeds.2020.07.037DOI Listing
December 2020

Lost in Transition: Is Early Respiratory Support in Newborn Infants the Best Option?

Neonatology 2020 16;117(4):517-521. Epub 2020 Jul 16.

Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.

Background: Late preterm and term newborns with respiratory distress are increasingly treated with non-invasive ventilation (NIV) including nasal high-flow or continuous positive airway pressure. For infants with mild distress, NIV may be unnecessary.

Objectives: We speculated that treatment with supplemental oxygen (SO) prior to NIV could help clinicians select infants for NIV treatment, and examined this hypothesis using data from a recently completed trial.

Method: Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial. Infants born at ≥36 weeks' gestation were categorized by whether they were receiving SO prior to randomization. The 2 groups were compared for illness severity (indicated by treatment failure at 72 h, mechanical ventilation, need for up-transfer, SO requirement post-randomization, and length of time receiving respiratory support), use of selected medical interventions (antibiotics, intravenous fluids), and breastfeeding at discharge.

Results: Analysis included 380 infants. Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%). Most infants in both groups received intravenous fluids (93 and 98%) and antibiotics (81 and 93%); the rate of full breastfeeding was low in both groups (51 and 45%).

Conclusions: Late preterm and term newborn infants without SO requirement at the time of commencing NIV for respiratory distress are at lower risk of requiring treatment escalation. Close observation of these infants (watch and wait strategy) may avoid unnecessary treatment.
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http://dx.doi.org/10.1159/000508554DOI Listing
August 2021

Cardiovascular response and sequelae after minimally invasive surfactant therapy in growth-restricted preterm infants.

J Perinatol 2020 08 6;40(8):1178-1184. Epub 2020 May 6.

Monash Newborn, Monash Children's Hospital, Melbourne, Vic, Australia.

Objective: To study cardiovascular response to minimally invasive surfactant therapy in preterm infants with and without foetal growth restriction (FGR).

Design: Poractant alfa was administered and echocardiograms were performed before and 30 min after. FGR infants were compared with those appropriate for gestational age (AGA).

Results: Ten FGR infants were compared with 20 AGA infants (gestation [weeks], 28.9 ± 2 vs. 28.6 ± 1, p = 0.55 and birthweight [g], 813 ± 157 vs. 1141 ± 257, p = 0.01, respectively). The change in echocardiographic parameters was more prominent in AGA infants ([global contractility] fractional area change [FAC, %], FGR, 24.7 ± 2.2 to 27.9 ± 0.4, p = 0.08 vs. AGA, 26.6 ± 3 to 30.5 ± 1, p < 0.01, and [longitudinal contractility] tricuspid annular plane systolic excursion [mm], FGR, 3.9 ± 0.3 to 4.6 ± 0.5, p = 0.003 vs. AGA, 4.6 ± 0.3 to 5.5 ± 0.4, p = 0.0001). Significant difference was noted for change in FAC (%), FGR 2.1 ± 1.7 vs. AGA 4.1 ± 1.2, p = 0.02.

Conclusions: Differential cardiovascular response to minimally invasive surfactant therapy amongst FGR infants may reflect an in-utero maladaptive state.
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http://dx.doi.org/10.1038/s41372-020-0682-5DOI Listing
August 2020

Use of Intraosseous Needles in Neonates: A Systematic Review.

Neonatology 2019 28;116(4):305-314. Epub 2019 Oct 28.

Newborn Services, John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust, Oxford, United Kingdom.

Background: The use of intraosseous (IO) access during resuscitation is widely accepted and promoted in paediatric medicine but features less prominently in neonatal training. Whilst umbilical venous catheterization (UVC) is a reliable method of delivering emergency drugs and fluids, it is not always achievable in a timely manner. IO access warrants exploration as an alternative.

Aim: Conduct a systematic review of existing literature to examine the evidence for efficacy and safety of IO devices in neonatal patients, from birth to discharge.

Method: A search of PubMed, Ovid, Medline, and Embase was carried out. Abstracts were screened for relevance to focus on neonatal-specific literature and studies which carried out separate analyses for neonates (infants <28 days of age or resident on a neonatal unit).

Results: One case series and 12 case reports describe IO device insertion into 41 neonates, delivering a variety of drugs, including adrenaline (epinephrine) and volume resuscitation. Complications range from none to severe. Cadaveric studies show that despite a small margin for error, IO devices can be correctly sited in neonates. Simulation studies suggest that IO devices may be faster and easier to site than UVC, even in experienced hands.

Conclusion: IO access should be available on neonatal units and considered for early use in neonates where other access routes have failed. Appropriate training should be available to staff in addition to existing life support and UVC training. Further studies are required to assess the optimal device, position, and whether medication can be delivered IO as effectively as by UVC. If IO devices provide a faster method of delivering adrenaline effectively than UVC, this may lead to changes in neonatal resuscitation practice.
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http://dx.doi.org/10.1159/000502212DOI Listing
June 2020

Predictors and Outcomes of Early Intubation in Infants Born at 28-36 Weeks of Gestation Receiving Noninvasive Respiratory Support.

J Pediatr 2020 01 11;216:109-116.e1. Epub 2019 Oct 11.

Newborn Research Centre, The Royal Women's Hospital, Melbourne, Victoria, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Victoria, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria, Australia.

Objective: To identify predictors and outcomes of early intubation in preterm infants with respiratory distress, and predictors of need for brief respiratory support (≤1 day).

Study Design: Secondary analysis of data from a randomized trial comparing nasal high-flow with continuous positive airway pressure as primary respiratory support in preterm infants born at 28-36 weeks of gestation. Intubation was assessed within 72 hours of randomization.

Results: There were 564 included infants with a mean (SD) gestational age of 32.0 (2.2) weeks and birth weight 1744 (589) g; 76 infants (13.5%) received early intubation. On multivariable analysis, lower gestational age and higher pre-randomization fraction of inspired oxygen (FiO) predicted intubation. A test based on gestational age of <30 weeks and an FiO of ≥0.30 produced a likelihood ratio of 9.1. Intubation was associated with prolonged duration of respiratory support and supplemental oxygen, with pneumothorax and nasal trauma, and in infants born at <32 weeks of gestational, with bronchopulmonary dysplasia and patent ductus arteriosus requiring treatment. Greater gestational age and lower FiO predicted the need for ≤1 day of respiratory support. A test based on a gestational age of ≥34 weeks and an FiO of 0.21 produced a likelihood ratio of 4.7.

Conclusions: In preterm infants 28-36 week of gestation receiving primary noninvasive respiratory support, lower gestational age, and higher FiO predicted need for intubation within 72 hours. Intubation was associated with adverse respiratory outcomes. Greater gestational age and lower FiO predicted need for ≤1 day of respiratory support. It may be reasonable to defer the use of respiratory support in more mature infants with low FiO requirements. TRIAL REGISTRATION AUSTRALIAN NEW ZEALAND CLINICAL TRIALS REGISTRY: ACTRN12613000303741.
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http://dx.doi.org/10.1016/j.jpeds.2019.09.026DOI Listing
January 2020

Issues in cardiopulmonary transition at birth.

Semin Fetal Neonatal Med 2019 12 23;24(6):101033. Epub 2019 Sep 23.

Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, the Netherlands.

The transition from fetal to newborn life involves a complex series of physiological events that commences with lung aeration, which is thought to involve 3 mechanisms. Two mechanisms occur during labour, Na reabsorption and fetal postural changes, and one occurs after birth due to pressure gradients generated by inspiration. However, only one of these mechanisms, fetal postural changes, involves the loss of liquid from the respiratory system. Both other mechanisms involve liquid being reabsorbed from the airways into lung tissue. While this stimulates an increase in pulmonary blood flow (PBF), in large quantities this liquid can adversely affect postnatal respiratory function. The increase in PBF (i) facilitates the onset of pulmonary gas exchange and (ii) allows pulmonary venous return to take over the role of providing preload for the left ventricle, a role played by umbilical venous return during fetal life. Thus, aerating the lung and increasing PBF before umbilical cord clamping (known as physiological based cord clamping), can avoid the loss of preload and reduction in cardiac output that normally accompanies immediate cord clamping.
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http://dx.doi.org/10.1016/j.siny.2019.101033DOI Listing
December 2019

Cardiorespiratory Physiology following Minimally Invasive Surfactant Therapy in Preterm Infants.

Neonatology 2019 5;116(3):278-285. Epub 2019 Sep 5.

Monash Newborn, Monash Children's Hospital, Melbourne, Victoria, Australia.

Introduction: Surfactant replacement therapy through the endotracheal tube has been shown to improve lung compliance and reduce pulmonary pressures. Minimally invasive surfactant therapy (MIST) combines the benefits of continuous positive airway pressure (CPAP) and surfactant for spontaneously breathing preterm infants. We aimed to characterize the haemodynamic changes accompanying the first dose of MIST in preterm infants.

Methods: Poractant alfa (200 mg/kg) was administered as MIST while on CPAP support. Echocardiograms were performed before (T1) and 30 (T2) and 60 min (T3) after MIST to assess serial change.

Results: Twenty infants (mean gestational age 29.5 ± 2.8 weeks, median birth weight 1,102 g, IQR 840-1,940) received MIST at a median age of 16 h (IQR 3-24). FiO2 decreased significantly at 30 min (0.41 ± 0.08 to 0.27 ± 0.03, p < 0.001). Significant changes were noted at T2 for ductal parameters (decreased % time right to left shunt: 25% [15-33] to 14.5% [6-22], p = 0.013). Reduced pulmonary vascular resistance (PVR; increased pulmonary artery time velocity ratio 0.23 ± 0.05 to 0.28 ± 0.04 ms, p = 0.004) and improved longitudinal (tricuspid annular plane systolic excursion 4.5 ± 0.8 to 5.3 ± 0.9 mm, p = 0.004) and global (fractional area change 25 ± 2.3 vs. 27 ± 2%, p = 0.002) ventricular function were noted.

Conclusions: This is the first study assessing cardiovascular adaptation to MIST, a procedure fast gaining acceptance in the neonatal community. Increased pulmonary blood flow is likely due to a combined effect of increased ductal flow, reduced PVR, and increased ventricular function.
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http://dx.doi.org/10.1159/000502040DOI Listing
June 2020

Nasal High-Flow Therapy for Newborn Infants in Special Care Nurseries.

N Engl J Med 2019 05;380(21):2031-2040

From the Newborn Research Centre and Neonatal Services, Royal Women's Hospital (B.J.M., L.S.O., P.G.D.), the Departments of Obstetrics and Gynaecology (B.J.M., L.S.O., P.G.D.) and Paediatrics (W.Q.F.), University of Melbourne, and Clinical Sciences, Murdoch Children's Research Institute (B.J.M., L.S.O., P.G.D.), Parkville, VIC, the University of New South Wales (G.R.B.A.) and the Sydney Medical School-Sydney Nursing School, University of Sydney (J.P.F.), Sydney, the Australian Institute of Health Innovation, Macquarie University, Sydney (G.R.B.A.), Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW (I.M.R.W.), Western Sydney University, Penrith, NSW (J.P.F.), Ingham Institute, Liverpool, NSW (J.P.F.), the Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Carlton, VIC (L.H.), Monash Newborn, Monash Children's Hospital, and the Department of Paediatrics, Monash University, Clayton, VIC (C.T.R.), Monash Newborn, Monash Health, Dandenong, VIC (T.L.C.), the Department of Paediatrics, Northern Hospital, Epping, VIC (W.Q.F.), Box Hill Hospital, Eastern Health, Box Hill, VIC (A.Y.W.F.), Women's and Children's Services, Barwon Health, Geelong, VIC (I.R.M.), the Department of Neonatology, Western Health, St. Albans, VIC (R.J.P.), the Department of Paediatrics, Central Coast Local Health District, Gosford, NSW (A.G.B.), and the School of Medicine and Public Health, University of Newcastle, Newcastle, NSW (A.G.B.) - all in Australia.

Background: Nasal high-flow therapy is an alternative to nasal continuous positive airway pressure (CPAP) as a means of respiratory support for newborn infants. The efficacy of high-flow therapy in nontertiary special care nurseries is unknown.

Methods: We performed a multicenter, randomized, noninferiority trial involving newborn infants (<24 hours of age; gestational age, ≥31 weeks) in special care nurseries in Australia. Newborn infants with respiratory distress and a birth weight of at least 1200 g were assigned to treatment with either high-flow therapy or CPAP. The primary outcome was treatment failure within 72 hours after randomization. Infants in whom high-flow therapy failed could receive CPAP. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome, with a noninferiority margin of 10 percentage points.

Results: A total of 754 infants (mean gestational age, 36.9 weeks, and mean birth weight, 2909 g) were included in the primary intention-to-treat analysis. Treatment failure occurred in 78 of 381 infants (20.5%) in the high-flow group and in 38 of 373 infants (10.2%) in the CPAP group (risk difference, 10.3 percentage points; 95% confidence interval [CI], 5.2 to 15.4). In a secondary per-protocol analysis, treatment failure occurred in 49 of 339 infants (14.5%) in the high-flow group and in 27 of 338 infants (8.0%) in the CPAP group (risk difference, 6.5 percentage points; 95% CI, 1.7 to 11.2). The incidences of mechanical ventilation, transfer to a tertiary neonatal intensive care unit, and adverse events did not differ significantly between the groups.

Conclusions: Nasal high-flow therapy was not shown to be noninferior to CPAP and resulted in a significantly higher incidence of treatment failure than CPAP when used in nontertiary special care nurseries as early respiratory support for newborn infants with respiratory distress. (Funded by the Australian National Health and Medical Research Council and Monash University; HUNTER Australian and New Zealand Clinical Trials Registry number, ACTRN12614001203640.).
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http://dx.doi.org/10.1056/NEJMoa1812077DOI Listing
May 2019

Haemodynamic Instability and Brain Injury in Neonates Exposed to Hypoxia⁻Ischaemia.

Brain Sci 2019 Feb 27;9(3). Epub 2019 Feb 27.

The Ritchie Centre, Hudson Institute of Medical Research, Monash University, Melbourne 3168, Australia.

Brain injury in the asphyxic newborn infant may be exacerbated by delayed restoration of cardiac output and oxygen delivery. With increasing severity of asphyxia, cerebral autoregulatory responses are compromised. Further brain injury may occur in association with high arterial pressures and cerebral blood flows following the restoration of cardiac output. Initial resuscitation aims to rapidly restore cardiac output and oxygenation whilst mitigating the impact of impaired cerebral autoregulation. Recent animal studies have indicated that the current standard practice of immediate umbilical cord clamping prior to resuscitation may exacerbate injury. Resuscitation prior to umbilical cord clamping confers several haemodynamic advantages. In particular, it retains the low-resistance placental circuit that mitigates the rebound hypertension and cerebrovascular injury. Prolonged cerebral hypoxia⁻ischaemia is likely to contribute to further perinatal brain injury, while, at the same time, tissue hyperoxia is associated with oxidative stress. Efforts to monitor and target cerebral flow and oxygen kinetics, for example, using near-infrared spectroscopy, are currently being evaluated and may facilitate development of novel resuscitation approaches.
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http://dx.doi.org/10.3390/brainsci9030049DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6468566PMC
February 2019

Assessment of resistance of nasal continuous positive airway pressure interfaces.

Arch Dis Child Fetal Neonatal Ed 2019 Sep 19;104(5):F535-F539. Epub 2018 Dec 19.

Monash Newborn, Monash Medical Centre, Clayton, Victoria, Australia.

Objective: To compare the resistance of interfaces used for the delivery of nasal continuous positive airway pressure (CPAP) in neonates, as measured by the generated system pressure at fixed gas flows, in an in vitro setting.

Design: Gas flows of 6, 8 and 10 L/min were passed through three sizes of each of a selection of available neonatal nasal CPAP interfaces (Hudson prong, RAM Cannula, Fisher & Paykel prong, Infant Flow prong, Fisher & Paykel mask, Infant Flow mask). The expiratory limb was occluded and pressure differential measured using a calibrated pressure transducer.

Results: Variation in resistance, assessed by mean pressure differential, was seen between CPAP interfaces. Binasal prong interfaces typically had greater resistance at the smallest assessed sizes, and with higher gas flows. However, Infant Flow prongs produced low pressures (<1.5 cmHO) at all sizes and gas flows. RAM Cannula had a high resistance, producing a pressure >4.5 cmHO at all sizes and gas flows. Both nasal mask interfaces had low resistance at all assessed sizes and gas flows, with recorded pressure <1 cmHO in all cases.

Conclusions: There is considerable variation in measured resistance of available CPAP interfaces at gas flows commonly applied in clinical neonatal care. Use of interfaces with high resistance may result in a greater drop in delivered airway pressure in comparison to set circuit pressure, which may have implications for clinical efficacy. Device manufacturers and clinicians should consider CPAP interface resistance prior to introduction into routine clinical care.
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http://dx.doi.org/10.1136/archdischild-2018-315838DOI Listing
September 2019

Cost-Effectiveness Analysis of Nasal Continuous Positive Airway Pressure Versus Nasal High Flow Therapy as Primary Support for Infants Born Preterm.

J Pediatr 2018 05 15;196:58-64.e2. Epub 2018 Mar 15.

Centre for Health Policy, The University of Melbourne, Melbourne, Australia. Electronic address:

Objective: To compare the cost-effectiveness of 2 common "noninvasive" modes of respiratory support for infants born preterm.

Study Design: An economic evaluation was conducted as a component of a multicenter, randomized control trial from 2013 to 2015 enrolling infants born preterm at ≥28 weeks of gestation with respiratory distress, <24 hours old, who had not previously received endotracheal intubation and mechanical ventilation or surfactant. The economic evaluation was conducted from a healthcare sector perspective and the time horizon was from birth until death or first discharge. The cost-effectiveness of continuous positive airway pressure (CPAP) vs high-flow with "rescue" CPAP backup and high-flow without rescue CPAP backup (as sole primary support) were analyzed by using the hospital cost of inpatient stay in a tertiary center and the rates of endotracheal intubation and mechanical ventilation during admission.

Results: Hospital inpatient cost records for 435 infants enrolled in all Australian centers were obtained. With "rescue" CPAP backup, an incremental cost-effectiveness ratio was estimated of A$179 000 (US$123 000) per ventilation avoided if CPAP was used compared with high flow. Without rescue CPAP backup, cost per ventilation avoided was A$7000 (US$4800) if CPAP was used compared with high flow.

Conclusions: As sole primary support, CPAP is highly likely to be cost-effective compared with high flow. Neonatal units choosing to use only one device should apply CPAP as primary respiratory support. Compared with high-flow with rescue CPAP backup, CPAP is unlikely to be cost-effective if willingness to pay per ventilation avoided is less than A$179 000 (US$123 000).
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http://dx.doi.org/10.1016/j.jpeds.2017.12.072DOI Listing
May 2018

Refining the Use of Nasal High-Flow Therapy as Primary Respiratory Support for Preterm Infants.

J Pediatr 2018 05 9;196:65-70.e1. Epub 2018 Mar 9.

Newborn Research Center, The Royal Women's Hospital, Melbourne, Australia; Department of Obstetrics and Gynecology, The University of Melbourne, Melbourne, Australia; Clinical Sciences, Murdoch Children's Research Institute, Melbourne, Victoria.

Objective: To identify clinical and demographic variables that predict nasal high-flow (nHF) treatment failure when used as a primary respiratory support for preterm infants.

Study Design: This secondary analysis used data from a multicenter, randomized, controlled trial comparing nHF with continuous positive airway pressure as primary respiratory support in preterm infants 28-36 completed weeks of gestation. Treatment success or failure with nHF was determined using treatment failure criteria within the first 72 hours after randomization. Infants in whom nHF treatment failed received continuous positive airway pressure, and were then intubated if failure criteria were again met.

Results: There were 278 preterm infants included, with a mean gestational age (GA) of 32.0 ± 2.1 weeks and a birth weight of 1737 ± 580 g; of these, nHF treatment failed in 71 infants (25.5%). Treatment failure was moderately predicted by a lower GA and higher prerandomization fraction of inspired oxygen (FiO): area under a receiver operating characteristic curve of 0.76 (95% CI, 0.70-0.83). Nasal HF treatment success was more likely in infants born at ≥30 weeks GA and with prerandomization FiO <0.30.

Conclusions: In preterm infants ≥28 weeks' GA enrolled in a randomized, controlled trial, lower GA and higher FiO before randomization predicted early nHF treatment failure. Infants were more likely to be successfully treated with nHF from soon after birth if they were born at ≥30 weeks GA and had a prerandomization FiO <0.30. However, even in this select population, continuous positive airway pressure remains superior to nHF as early respiratory support in preventing treatment failure.

Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000303741.
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http://dx.doi.org/10.1016/j.jpeds.2018.01.031DOI Listing
May 2018

Retrospective Consent in a Neonatal Randomized Controlled Trial.

Pediatrics 2018 01;141(1)

Newborn Research Centre and.

Background And Objectives: The requirement for prospective consent in clinical trials in acute settings may result in samples unrepresentative of the study population, potentially altering study findings. However, using retrospective consent may raise ethical issues. We assessed whether using retrospective consent affected recruitment, participant characteristics, and outcomes within a randomized controlled trial.

Methods: We conducted a secondary analysis of a randomized trial, which compared nasal high flow (nHF) with nasal continuous positive airway pressure (CPAP) for primary respiratory support in preterm infants. In Era 1, all infants were consented prospectively; in Era 2, retrospective consent was available. We assessed inclusion rates of eligible infants, demographic data, and primary trial outcome (treatment failure within 72 hours).

Results: In Era 1, recruitment of eligible infants was lower than in Era 2: 111 of 220 (50%) versus 171 of 209 (82%), < .001; intrapartum antibiotic administration was lower: 23 of 111 (21%) versus 84 of 165 (51%), < .001; full courses of antenatal steroids were higher: 86 of 111 (78%) versus 103 of 170 (61%), = .004; and more infants received pre-randomization CPAP: 77 of 111 (69%) versus 48 of 171 (28%), < .001. In Era 1, nHF failure (15 of 56, 27%) and CPAP failure (14 of 55, 26%) rates were similar, = .9. In Era 2, failure rates differed: 24 of 85 (28%) nHF infants versus 13 of 86 (15%) CPAP infants, = .04. The χ interaction test was nonsignificant ( = .20).

Conclusions: The use of retrospective consent resulted in greater recruitment and differences in risk factors between eras. Using retrospective consent altered the study sample, which may be more representative of the whole population. This may improve scientific validity but requires further ethical evaluation.
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http://dx.doi.org/10.1542/peds.2017-2092DOI Listing
January 2018

Nasal high flow treatment in preterm infants.

Matern Health Neonatol Perinatol 2017 6;3:15. Epub 2017 Sep 6.

Newborn Research Centre, The Royal Women's Hospital, Locked Bag 300, Flemington Road, Parkville 3052, Melbourne, VIC Australia.

Nasal High Flow (HF) is a mode of 'non-invasive' respiratory support for preterm infants, with several potential modes of action, including generation of distending airway pressure, washout of the nasopharyngeal dead space, reduction of work of breathing, and heating and humidification of inspired gas. HF has several potential advantages over continuous positive airway pressure (CPAP), the most commonly applied form of non-invasive support, such as reduced nasal trauma, ease of use, and infant comfort, which has led to its rapid adoption into neonatal care. In recent years, HF has become a well-established and commonly applied treatment in neonatal care. Recent trials comparing HF and CPAP as primary support have had differing results. Meta-analyses suggest that primary HF results in an increased risk of treatment failure, but that 'rescue' CPAP use in those infants with HF failure results in no greater risk of mechanical ventilation. Even in studies with higher rates of HF failure, the majority of infants were successfully treated with HF, and rates of important neonatal morbidities did not differ between treatment groups. Importantly, these studies have included only infants born at ≥28 weeks' gestational age (GA). The decision whether to apply primary HF will depend on the value placed on its advantages over CPAP by clinicians, the approach to surfactant treatment, and the severity of respiratory disease in the relevant population of preterm infants. Post-extubation HF use results in similar rates of treatment failure, mechanical ventilation, and adverse events compared to CPAP. Post-extubation HF appears most suited to infants ≥28 weeks; there are few published data for infants below this gestation, and available evidence suggests that these infants are at high risk of HF failure, although rates of intubation and other morbidities are similar to those seen with CPAP. There is no evidence that using HF to 'wean' off CPAP allows for respiratory support to be ceased more quickly, but given its advantages it would appear to be a suitable alternative in infants who require ongoing non-invasive support. Safety data from randomised trials are reassuring, although more evidence in extremely preterm infants (<28 weeks' GA) is required.
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http://dx.doi.org/10.1186/s40748-017-0056-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5586012PMC
September 2017
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