Publications by authors named "Gianluca Lista"

94 Publications

A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth.

Resuscitation 2021 Jul 21. Epub 2021 Jul 21.

Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, Netherlands. Electronic address:

Aim: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations with an expiratory tidal volume (Vte) within a predefined target range.

Methods: Unmasked, randomised clinical trial conducted October 2013 - May 2019 in 7 neonatal intensive care units in 6 countries. Very preterm infants (24-27 weeks of gestation) receiving PPV at birth were randomised to have a RFM screen visible or not. The primary outcome was the median proportion of inflations during manual PPV (face mask or intubated) within the target range (Vte 4-8 mL/kg). There were 42 other prespecified monitor measurements and clinical outcomes.

Results: Among 288 infants randomised (median (IQR) gestational age 26 (25-27) weeks), a total number of 51,352 inflations were analysed. The median (IQR) percentage of inflations within the target range in the RFM visible group was 30.0 (18.0-42.2)% vs 30.2 (14.8-43.1)% in the RFM non-visible group (p=0.721). There were no differences in other respiratory function measurements, oxygen saturation, heart rate or FiO. There were no differences in clinical outcomes, except for the incidence of intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% vs non-visible RFM: 39.0%; RR 0.71 (0.68-0.97); p=0.028).

Conclusion: In very preterm infants receiving PPV at birth, the use of a RFM, compared to no RFM as guidance for tidal volume delivery, did not increase the percentage of inflations in a predefined target range. Trial registration Dutch Trial Register NTR4104, clinicaltrials.gov NCT03256578.
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http://dx.doi.org/10.1016/j.resuscitation.2021.07.012DOI Listing
July 2021

Neonatal lung ultrasound and surfactant administration: a pragmatic, multicenter study.

Chest 2021 Jul 19. Epub 2021 Jul 19.

Neonatal Intensive Care Unit, Vittore Buzzi Children's Hospital, Milan, Italy.

Background: Previous research shows that a lung ultrasound score (LUS) can anticipate CPAP failure in neonatal respiratory distress syndrome.

Research Question: Can LUS also predict the need for surfactant replacement?

Study Design And Methods: Multicenter, pragmatic study on preterm neonates who underwent lung ultrasound at birth and those given surfactant by masked physicians were also scanned within 24 hours from administration. Clinical data and respiratory support variables were recorded. Accuracy of LUS, SatO/FiO FiO and Silverman score for surfactant administration were evaluated using receiver operating curves. The simultaneous prognostic value of LUS and SatO/FiO for surfactant administration, adjusting for gestational age, were analyzed through logistic regression model.

Results: Two hundred forty infants were enrolled. One-hundred eight received at least one dose of surfactant. LUS predicted the first surfactant administration with an area under the curve (AUC) = 0.86 (95%CI 0.81-0.91) cut-off=9 Sensitivity=0.79 (95% CI, 0.70; 0.86), Specificity=0.83 (95% CI, 0.76; 0.89), Positive Predictive Value =0.79 (95% CI, 0.71; 0.87), Negative Predictive Value=0.82 (95% CI, 0.75; 0.89), Likelihood Ratio +=4.65 (95% CI, 3.14; 6.89), and Likelihood Ratio -= 0.26 (95% CI, 0.18; 0.37). No significant difference was shown among different gestational age (GA) groups: 25-27 (AUC =0.91; 95% CI 0.84-0.99), 28-30 (AUC=0.81; 95% CI 0.72-0.91), 31-33 (AUC = 0.88; 95% CI 0.79-0.95) weeks GA, respectively. LUS declined significantly within 24 hours in babies receiving one surfactant dose. When comparing FiO, SatO/FiO, LUS and Silverman scores as criteria for surfactant administration, only the latter had a significantly poorer performance. The combination of SatO/FiO and LUS had the highest predictive power with AUC = 0.93 (95%CI 0.89-0.97) regardless of the GA interval.

Interpretation: LUS is a reliable criterion to administer the first surfactant dose irrespective of GA. Its association with SatO/FiO significantly improves the prediction power for surfactant need.
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http://dx.doi.org/10.1016/j.chest.2021.06.076DOI Listing
July 2021

Neonatal Dyshormonogenetic Goiter with Hypothyroidism Associated with Novel Mutations in Thyroglobulin and SLC26A4 Gene.

Pediatr Rep 2021 May 2;13(2):210-215. Epub 2021 May 2.

Pediatric Unit, Department of Pediatrics, "Vittore Buzzi" Children's Hospital, 20154 Milan, Italy.

Congenital goiter is an uncommon cause of neck swelling and it can be associated with hypothyroidism. We discuss a case of primary hypothyroidism with goiter presenting at birth. Ultrasound showed the enlargement of the gland and thyroid function tests detected marked hypothyroidism. Genetic analysis via next generation sequencing (NGS) was performed finding two mutations associated with thyroid dyshormonogenesis: c.7813 C > T, homozygous in the exon 45 of the thyroglobulin gene (TG) and c.1682 G > A heterozygous in exon 15 of the SLC26A4 gene (pendrin). Sanger sequencing of parents' DNA samples revealed that the first mutation (c.7813 C > T) was inherited from both of them, while the second one (c.1682 G > A) was inherited from the mother. Hormone replacement therapy was started, following which a gradual decrease in the size of the goiter was seen with the normalization of hormonal levels. Normal infant growth status and neurological development were recorded during follow-up. Neonatal dyshormonogenetic goiter with hypothyroidism may represent an unusual cause of neonatal neck mass. Early identification and hormone replacement therapy are crucial for a better neurodevelopmental outcome. Genetic analysis is mandatory in order to reach a specific diagnosis and to elucidate new patterns of thyroid disorder.
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http://dx.doi.org/10.3390/pediatric13020029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8163152PMC
May 2021

Delivery Room Management of Asphyxiated Term and Near-Term Infants.

Neonatology 2021 May 21:1-13. Epub 2021 May 21.

Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Edmonton, Alberta, Canada.

Approximately 800,000 newborns die annually due to birth asphyxia. The resuscitation of asphyxiated term newly born infants often occurs unexpected and is challenging for healthcare providers as it demands experience and knowledge in neonatal resuscitation. Current neonatal resuscitation guidelines often focus on resuscitation of extremely and/or very preterm infants; however, the recommendations for asphyxiated term newborn infants differ in some aspects to those for preterm infants (i.e., respiratory support, supplemental oxygen, and temperature management). Since the update of the neonatal resuscitation guidelines in 2015, several studies examining various resuscitation approaches to improve the outcome of asphyxiated infants have been published. In this review, we discuss current recommendations and recent findings and provide an overview of delivery room management of asphyxiated term newborn infants.
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http://dx.doi.org/10.1159/000516429DOI Listing
May 2021

Efficacy of Everolimus Low-Dose Treatment for Cardiac Rhabdomyomas in Neonatal Tuberous Sclerosis: Case Report and Literature Review.

Pediatr Rep 2021 Mar 1;13(1):104-112. Epub 2021 Mar 1.

Pediatric Cardiology Unit, "Vittore Buzzi" Children's Hospital, 20154 Milano, Italy.

: Cardiac rhabdomyomas (CRs) are the most common cardiac tumors in newborns. Approximately 80-90% of cases are associated with tuberous sclerosis complex (TSC). In selective cases, Everolimus has resulted in a remarkable tumoral regression effect in children with TS. The optimal dosage for neonates is still unknown. : We describe the use of Everolimus in a neonate with multiple biventricular CRs, causing subaortic obstruction, in which a low-dose treatment (0.1 mg/die), in an effort to maintain serum trough levels of 3-7 ng/mL, was successfully used off-label, without adverse effects. : We showed that a low-dose Everolimus regimen may be an effective and safe treatment for CR regression in TS neonates, when the minimum therapeutic range was maintained.
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http://dx.doi.org/10.3390/pediatric13010015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931111PMC
March 2021

Lung Ultrasound Score Progress in Neonatal Respiratory Distress Syndrome.

Pediatrics 2021 04 9;147(4). Epub 2021 Mar 9.

NICU, Vittore Buzzi Children's Hospital, Milan, Italy.

Background And Objectives: The utility of a lung ultrasound score (LUS) has been described in the early phases of neonatal respiratory distress syndrome (RDS). We investigated lung ultrasound as a tool to monitor respiratory status in preterm neonates throughout the course of RDS.

Methods: Preterm neonates, stratified in 3 gestational age cohorts (25-27, 28-30, and 31-33 weeks), underwent lung ultrasound at weekly intervals from birth. Clinical data, respiratory support variables, and major complications (sepsis, patent ductus arteriosus, pneumothorax, and persistent pulmonary hypertension of the neonate) were also recorded.

Results: We enrolled 240 infants in total. The 3 gestational age intervals had significantly different LUS patterns. There was a significant correlation between LUS and the ratio of oxygen saturation to inspired oxygen throughout the admission, increasing with gestational age (b = -0.002 [ < .001] at 25-27 weeks; b = -0.006 [ < .001] at 28-30 weeks; b = -0.012 [ < .001] at 31-33 weeks). Infants with complications had a higher LUS already at birth (12 interquartile range 13-8 vs 8 interquartile range 12-4 control group; = .001). In infants 25 to 30 weeks' gestation, the LUS at 7 days of life predicted bronchopulmonary dysplasia with an area under the curve of 0.82 (95% confidence interval 0.71 to 93).

Conclusions: In preterm neonates affected by RDS, the LUS trajectory is gestational age dependent, significantly correlates with the oxygenation status, and predicts bronchopulmonary dysplasia. In this population, LUS is a useful, bedside, noninvasive tool to monitor the respiratory status.
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http://dx.doi.org/10.1542/peds.2020-030528DOI Listing
April 2021

The neonatal assessment manual score (NAME) for improving the clinical management of infants: a perspective validity study.

Ital J Pediatr 2021 Mar 7;47(1):53. Epub 2021 Mar 7.

RAISE lab, Foundation COME Collaboration, Corso Europa 29 - 66054 Vasto (Italy), Pescara, Italy.

Background And Objectives: The Neonatal Assessment Manual scorE (NAME) was developed to assist in the clinical management of infants in the neonatal ward by assessing their body's compliance and homogeneity. The present study begins its validation process.

Methods: An expert panel of neonatal intensive care unit (NICU) professionals investigated the NAME face and content validity. Content validity was assessed through the content validity index (CVI). Construct validity was assessed using data collected from 50 newborns hospitalized in the NICU of "Vittore Buzzi" Children Hospital of Milan, Italy. Kendall's τ and ordinal logistic regressions were used to evaluate the correlation between the NAME scores and infants' gestational age, birth weight, post-menstrual age, weight at the time of assessment, and a complexity index related to organic complications.

Results: The CVIs for compliance, homogeneity, and the whole scale were respectively 1, 0.9, and 0.95. Construct validity analysis showed significant positive correlations between the NAME and infants' weight and age, and a negative correlation between the NAME and the complexity index (τ = - 0.31 [95% IC: - 0.47, - 0.12], p = 0.016 and OR = 0.56 [95% IC: 0.32, 0.94], p = 0.034 for categorical NAME; τ = - 0.32 [95% IC: - 0.48, - 0.14], p = 0.005 for numerical NAME).

Conclusions: The NAME was well accepted by NICU professionals in this study and it demonstrates good construct validity in discriminating the infant's general condition. Future studies are needed to test the NAME reliability and predictive capacity.
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http://dx.doi.org/10.1186/s13052-021-01012-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938573PMC
March 2021

Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study.

Arch Dis Child Fetal Neonatal Ed 2021 Feb 17. Epub 2021 Feb 17.

Department of Woman and Child Health, University Hospital of Padova, Padova, Italy

Background: The thermal servo-controlled systems are routinely used in neonatal intensive care units (NICUs) to accurately manage patient temperature, but their role during the immediate postnatal phase has not been previously assessed.

Objective: To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth.

Study Design And Setting: Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals.

Participants: Infants with estimated birth weight <1500 g and/or gestational age <30 weeks.

Intervention: Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room.

Primary Outcome: Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C).

Results: At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01).

Conclusions: In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge.

Trial Registration Number: NCT03844204.
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http://dx.doi.org/10.1136/archdischild-2020-320567DOI Listing
February 2021

Neuroimaging and neurodevelopmental outcome after early fetal growth restriction: NEUROPROJECT-FGR.

Pediatr Res 2021 Jan 19. Epub 2021 Jan 19.

Department of Woman, Mother and Child, Buzzi Hospital, University of Milan, via Castelvetro 32, 20154, Milan, Italy.

Background: Adverse neurodevelopmental outcomes and MRI alterations are reported in infants born after fetal growth restriction (FGR). This study evaluates the additional role of FGR over prematurity in determining brain impairment.

Methods: Retrospective observational study comparing 48 FGR and 36 appropriate for gestational age infants born between 26 and 32 weeks' gestation who underwent a cerebral MRI at term equivalent age. Exclusion criteria were twins, congenital anomalies, and findings of overt brain lesions. Main outcomes were total maturation score (TMS) and cerebral areas independently measured by two neuro-radiologists and Griffiths or Bayley scale III scores at median age of 2 years.

Results: TMS was not significantly different between the groups. Inner calvarium and parenchyma's areas were significantly smaller in FGR cases. There were no significant differences in the average quotient scores. A positive correlation between parenchyma area and cognitive score was found (r = 0.372, p = 0.0078) and confirmed after adjusting for sex, gestational age, and birth weight (p = 0.0014). Among FGR, the subgroup with umbilical arterial Doppler velocimetry alterations had significantly worse gross motor scores (p = 0.005).

Conclusions: FGR plays additional role over prematurity in determining brain impairment. An early structural dimensional MRI evaluation may identify infants who are at higher risk.

Impact: Fetal growth-restricted infants showed smaller cerebral parenchymal areas than preterm controls. There is a positive correlation between the parenchyma area and the cognitive score. These results highlight the already known link between structure and function and add importance to the role of a structural dimensional MRI evaluation even in the absence of overt brain lesions.
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http://dx.doi.org/10.1038/s41390-020-01333-1DOI Listing
January 2021

Surfactant lung delivery with LISA and InSurE in adult rabbits with respiratory distress.

Pediatr Res 2021 Jan 15. Epub 2021 Jan 15.

Neonatal Intensive Care Unit, "V. Buzzi" Children's Hospital, ASST-FBF-Sacco, Milan, Italy.

Background: In preterm infants, InSurE (Intubation-Surfactant-Extubation) and LISA (less invasive surfactant administration) techniques allow for exogenous surfactant administration while reducing lung injury associated with mechanical ventilation. We compared the acute pulmonary response and lung deposition of surfactant by LISA and InSurE in surfactant-depleted adult rabbits.

Methods: Twenty-six spontaneously breathing surfactant-depleted adult rabbits (6-7 weeks old) with moderate RDS and managed with nasal continuous positive airway pressure were randomized to 3 groups: (1) 200 mg/kg of surfactant by InSurE; (2) 200 mg/kg of surfactant by LISA; (3) no surfactant treatment (Control). Gas exchange and lung mechanics were monitored for 180 min. After that, surfactant lung deposition and distribution were evaluated monitoring disaturated-phosphatidylcholine (DSPC) and surfactant protein C (SP-C), respectively.

Results: No signs of recovery were found in the untreated animals. After InSurE, oxygenation improved more rapidly compared to LISA. However, at 180' LISA and InSurE showed comparable outcomes in terms of gas exchange, ventilation parameters, and lung mechanics. Neither DSPC in the alveolar pool nor SP-C signal distributions in a frontal lung section were significantly different between InSurE and LISA groups.

Conclusions: In an acute setting, LISA demonstrated efficacy and surfactant lung delivery similar to that of InSurE in surfactant-depleted adult rabbits.

Impact: Although LISA technique is gaining popularity, there are still several questions to address. This is the first study comparing LISA and InSurE in terms of gas exchange, ventilation parameters, and lung mechanics as well as surfactant deposition and distribution. In our animal study, three hours post-treatment, LISA method seems to be as effective as InSurE and showed similar surfactant lung delivery. Our findings provide some clarifications on a fair comparison between LISA and InSurE techniques, particularly in terms of surfactant delivery. They should reassure some of the concerns raised by the clinical community on LISA adoption in neonatal units.
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http://dx.doi.org/10.1038/s41390-020-01324-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7809896PMC
January 2021

Response to therapy among neonates with gastro-esophageal reflux is associated with esophageal clearance.

Early Hum Dev 2021 01 10;152:105248. Epub 2020 Nov 10.

Neonatal Unit, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Largo A. Gemelli 8, 00168 Rome, Italy.

Background: Few studies evaluated the efficacy of pharmacological therapy for gastro-esophageal reflux disease (GERD) in newborns, whose safety has been questioned. Esophageal basal impedance (BI) is a marker of mucosal integrity, and treatment with proton pump inhibitors significantly increases BI in infants; however, no correlation with clinical improvement was reported.

Aims: To evaluate the relationship between BI and other esophageal pH-impedance parameters and clinical response to therapy in newborns with GERD.

Study Design: Multicenter retrospective study.

Subjects: Infants who received omeprazole or ranitidine for GERD.

Outcome Measures: Complete response to therapy was defined as symptom decrease by ≥50% compared to baseline, partial response as symptom decrease <50%, no response as no symptom decrease based on chart analysis. Response to therapy was assessed 2 and 4 weeks after the onset of therapy. Univariate and multivariate statistics were performed to assess associations between response to therapy and clinical/pH-impedance parameters.

Results: We studied 60 infants (51 born preterm): 47 received omeprazole, 13 ranitidine. Response to therapy was associated with decreasing esophageal clearance time: odds ratio 0.308, 95%CI 0.126-0.753, p = 0.010 at 2 weeks, odds ratio 0.461, 95%CI 0.223-0.955, p = 0.037 at 4 weeks.

Conclusions: Clinical response to therapy among infants with GERD was associated with esophageal clearance but not with esophageal BI level.
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http://dx.doi.org/10.1016/j.earlhumdev.2020.105248DOI Listing
January 2021

Flow-synchronized NIPPV with double-inspiratory loop cannula: An in vitro study.

Pediatr Pulmonol 2021 02 19;56(2):400-408. Epub 2020 Nov 19.

Neonatal Intensive Care Unit and Neonatology, "San Giovanni Calibita" Fatebenefratelli Hospital - Isola Tiberina, Rome, Italy.

Background: Although short binasal prongs (SBP) are the most common interface for noninvasive ventilation, the "double-inspiratory loop cannulas" (DILC) have recently been introduced into many neonatal intensive care units. DILC show advantages over SBP, including reduced nasal trauma and increased comfort. However, their higher intrinsic resistance may compromise ventilation. Our aim was to test a new, low resistance DILC interface.

Methods: A test lung was programmed to simulate preterm neonates (500-2000 g BW) with moderate-to-severe respiratory distress syndrome. The artificial nose was designed to keep prongs-to-nares leaks to around 30%. Giulia® ventilator (GINEVRI srl) was used to provide nasal continuous positive airway pressure (NCPAP) and flow synchronized nasal intermittent positive pressure ventilation (NIPPV). NCPAP was set at 4-10 cmH O and synchronized-NIPPV (SNIPPV) at peak inspiratory pressure, 15-20-25 cmH O; inspiratory time, 0.3-0.5 s; and positive end-expiratory pressure, 5-8 cmH O. Four sizes of Sync-flow Cannula® (GINEVRI srl) were tested. The Sync-flow Cannula® was compared with Neotech RAM® cannula and Ginevri SBP®. The outcome measures were the flow/pressure relationship through the four Sync-flow Cannula® sizes, the difference in resistance, the drop in ventilator-alveoli pressure measured by the test lung and the system response time during flow-SNIPPV.

Results: The smaller DILC sizes had the lowest flow-pressure ratio. The resistance of the RAM® cannula was significantly higher compared to the other interfaces (p < .001). With 30% leaks, there was a 4-38% ventilator-alveoli drop in pressure, depending on interface size. The system response time was excellent (~65-70 ms).

Conclusions: With about 30% leaks, the Sync-flow Cannula® interfaces result in good pressure transmission and give optimal performance for flow-SNIPPV. Clinical studies are needed to confirm the clinical relevance of these data.
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http://dx.doi.org/10.1002/ppul.25161DOI Listing
February 2021

Respiratory Support of Neonate Affected by Bronchiolitis in Neonatal Intensive Care Unit.

Am J Perinatol 2020 09 8;37(S 02):S10-S13. Epub 2020 Sep 8.

Division of Neonatology, "V. Buzzi" Children's Hospital, Milan, Italy.

Acute respiratory infections are very common medical emergency in early infancy, often requiring hospitalization. The most frequent respiratory infection at this stage of life is bronchiolitis, with a benign course in the majority of cases. However, especially during neonatal period, infants are at higher risk for developing complications, and ventilatory support of various degrees is needed. The two most widespread methods to provide noninvasive respiratory support are heated humidified high-flow nasal cannula and nasal continuous positive airway pressure. They are both used in neonatal intensive care unit to treat respiratory distress syndrome of the premature infants, and the main concept of recruiting and distending alveoli is valid also for respiratory failure occurring during bronchiolitis. However, there is still ongoing debate about the superiority of one method, and their real efficacy still need to be confirmed. Once respiratory failure does not respond to noninvasive ventilation, more intensive care must be provided in the form of conventional mechanical ventilation or high-frequency ventilation. There is currently no evidence of the optimal ventilation strategy to use, and a deeper comprehension of the pulmonary mechanics during bronchiolitis would be desirable to tailor ventilation according to the degree of severity. Further research is then urgently needed to better clarify these aspects. KEY POINTS: · Guidelines on the management of bronchiolitis in neonatal population are lacking.. · Noninvasive respiratory support is mostly delivered with HHHFNC and nCPAP.. · A deeper comprehension of the pulmonary mechanics during bronchiolitis is crucial to tailor invasive ventilation..
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http://dx.doi.org/10.1055/s-0040-1713604DOI Listing
September 2020

Intravenous paracetamol in comparison with ibuprofen for the treatment of patent ductus arteriosus in preterm infants: a randomized controlled trial.

Eur J Pediatr 2021 Mar 4;180(3):807-816. Epub 2020 Sep 4.

Angelini Pharma S.p.A, Viale Amelia 70, 00181, Rome, Italy.

Our aim was to assess the efficacy and safety of intravenous (i.v.) paracetamol vs. i.v. ibuprofen for the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25-31 weeks were randomized to receive i.v. paracetamol (15 mg/kg/6 h for 3 days) or i.v. ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with paracetamol or ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received paracetamol or ibuprofen, respectively. Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar.Conclusions: Intravenous paracetamol was less effective in closing hsPDA than ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.Trial registration: Clinicaltrials.gov : NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: • The successful closure of patent ductus arteriosus with oral paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous paracetamol. What is New: • Intravenous paracetamol is less effective in closing hsPDA than ibuprofen, but have a similar constriction effect. • These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.
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http://dx.doi.org/10.1007/s00431-020-03780-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7886841PMC
March 2021

Neonatal Assessment Manual Score: Is There a Role of a Novel, Structured Touch-Based Evaluation in Neonatal Intensive Care Unit?

Front Pediatr 2020 6;8:432. Epub 2020 Aug 6.

Division of Neonatology, "V. Buzzi" Children's Hospital, ASST-FBF-Sacco, Milan, Italy.

Despite the technological improvements in monitoring preterm infants in the neonatal intensive care unit, routine care in the neonatal ward is primarily based on manual procedures. Although manual clinical procedures play a critical role in neonatology, little attention has been paid to palpation as a clinical assessment tool. Palpation is a clinical evaluation tool that relies mostly on the senses of touch and proprioception. Based on recent studies investigating the role and clinical effectiveness of touch in full-term and preterm babies, this paper proposes an evaluative touch-based procedure-the Neonatal Assessment Manual Score (NAME) model-that could be useful in the neonatal ward and describes its rationale. The operator applies gentle light pressures to the infant's body. In essence, the touch stimulates low-threshold afferent fibers that could influence the interoceptive cerebral network and the autonomic nervous system, thus altering the blood flow and breathing rhythm. These events could change how bodily fluids distribute among body segments and hence the body volume. The volume modification could be felt manually through haptic perception owing to the high sensitivity of the fingers. On the basis of their clinical conditions and stage of development, infants will respond differently to the applied pressures. Evaluating the infant's response, the operator produces a score of "bad," "marginal," or "good" for communicating quickly and clearly the infant's conditions to other professionals. Because the NAME model is intended for every professional who is used to touch-based procedures, if future studies confirmed its validity and reliability in clinical practice, the NAME model could become a part of the neonatal ward routine care for better assessing and managing the infant's conditions, even during emergencies.
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http://dx.doi.org/10.3389/fped.2020.00432DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7424031PMC
August 2020

Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial.

Complement Ther Clin Pract 2020 May 8;39:101116. Epub 2020 Feb 8.

Division of Neonatology, "V. Buzzi" Children's Hospital, ASST-FBF-Sacco, Milan, Italy.

Background: Osteopathic manipulative treatment (OMT) has been successfully tested in the context of preterm infants. No studies, however, have been conducted to investigate the OMT immediate effects on physiological measurements, such as partial oxygen saturation (SpO2) and heart rate (HR). The purpose of the present study was to assess the effect of osteopathic treatment on SpO2 and HR values and to compare it with 10 min of static touch.

Materials And Methods: Ninety-six preterm infants (41 male), aged 33.5 weeks (±4.3) with mean weight at birth of 2067gr (±929) were recruited from the neonatal intensive care unit (NICU) of the Buzzi Hospital in Milan, and randomly allocated to two groups: OMT and Static Touch. Each protocol session consisted of: a) 5-min Pre-touch baseline recording, b) 10-min touch procedure, c) 5-min post-touch recording. Primary and secondary outcomes were, respectively, the baseline changes of HR and SpO2.

Results: The 2 × 2 repeated measure ANOVA for HR showed a statistically significant effect (F (1,94) = 5.34; p < 0.02), revealing that the OMT group decreases the HR value at T2 (p = 0.006). In contrast, SpO2 analysis showed an increase of SpO2 value where the OMT group demonstrated higher values at T2 (p = 0.04).

Conclusion: Results from the present study suggest that a single osteopathic intervention may induce beneficial effects on preterm physiological parameters.

Trial Registration: ClinicalTrials.gov identifier: NCT03833635 - Date: February 7, 2019.
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http://dx.doi.org/10.1016/j.ctcp.2020.101116DOI Listing
May 2020

Fatherhood during the COVID-19 pandemic: an unexpected turnaround.

Early Hum Dev 2020 05 24;144:105048. Epub 2020 Apr 24.

Division of Neonatology, "V.Buzzi" Children's Hospital, ASST-FBF-Sacco, Milan, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.earlhumdev.2020.105048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194733PMC
May 2020

Body temperature at nursery admission in a cohort of healthy newborn infants: results from an observational cross-sectional study.

Ital J Pediatr 2020 Apr 15;46(1):46. Epub 2020 Apr 15.

Division of Neonatology, "V. Buzzi" Children's Hospital, ASST-FBF-Sacco, Milan, Italy.

Background: Exposure to hypothermia is somehow unavoidable when a baby comes to life. This is the reason why any possible effort should be made by every caregiver involved during birth, from labour to transfer into the maternity ward, to reduce it. Hypothermia has widely shown to be related to several neonatal problems, and the risks are more relevant when the babies are born prematurely.

Method: An observational study was conducted in April 2016 to assess the current practises to avoid hypothermia at birth in 20 Italian neonatal units. Each unit introduced local improvements in clinical practice and the same observational study was repeated 1 year later.

Results: A total of 4722 babies were analysed. An overall increase in adherence to local and international recommendations emerged from our study. Significant differences between 2016 and 2017 were found in regard to neonatal temperature at nursery entry (36.3 °C vs 36.5 °C, respectively, p < 0.0001), delayed cord clamping practice > 60″ (48.1% vs 68.1%, respectively, p < 0.0001) and skin-to-skin practice > 60' (56.3% vs 60.9, respectively, p = 0.03). Statistical correlations with the risk of hypothermia were found for delivery room (OR 0.88 (CI 95%0.83-0.94), p < 0.0001) and maternal temperature (OR 0.57 (CI 95% 0.48-0.67), p < 0.0001).

Conclusion: Periodical assessment of the delivery room practice has shown to be effective in improving adherence to the international recommendations. Relationship between neonatal hypothermia and several other variables including the delivery room and mother temperature underlines how neonatal thermoregulation starts immediately after birth. Hence, a multi-disciplinary approach is needed to provide the optimal environment for a safe birth.
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http://dx.doi.org/10.1186/s13052-020-0810-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7157981PMC
April 2020

Monochorionic diamniotic twin pregnancy complicated by discordant premature closure of ductus arteriosus.

Clin Case Rep 2020 Apr 9;8(4):685-689. Epub 2020 Mar 9.

Fetal Therapy Unit 'Umberto Nicolini' V. Buzzi Children's Hospital University of Milan Milan Italy.

Prenatal DA closure due to early maternal intake of high-dose paracetamol and selective serotonin reuptake inhibitors. MC twin pregnancy uncomplicated by TTTS with discordant prenatal DA closure.
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http://dx.doi.org/10.1002/ccr3.2717DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7141735PMC
April 2020

Sustained Inflation vs Standard Resuscitation for Preterm Infants: A Systematic Review and Meta-analysis.

JAMA Pediatr 2020 04 6;174(4):e195897. Epub 2020 Apr 6.

Division of Biostatistics, Department of Public Health Sciences, University of Virginia, Charlottesville.

Importance: Most preterm infants require respiratory support to establish lung aeration after birth. Intermittent positive pressure ventilation and continuous positive airway pressure are standard therapies. An initial sustained inflation (inflation time >5 seconds) is a widely practiced alternative strategy.

Objective: To conduct a systematic review and meta-analysis of sustained inflation vs intermittent positive pressure ventilation and continuous positive airway pressure for the prevention of hospital mortality and morbidity for preterm infants.

Data Sources: MEDLINE (through PubMed), Embase, the Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials were searched through June 24, 2019.

Study Selection: Randomized clinical trials of preterm infants born at less than 37 weeks' gestation that compared sustained inflation (inflation time >5 seconds) vs standard resuscitation with either intermittent positive pressure ventilation or continuous positive airway pressure were included. Studies including other cointerventions were excluded.

Data Extraction And Synthesis: Two reviewers assessed the risk of bias of included studies. Meta-analysis of pooled outcome data used a fixed-effects model specific to rarer events. Subgroups were based on gestational age and study design (rescue vs prophylactic sustained inflation).

Main Outcomes And Measures: Death before hospital discharge.

Results: Nine studies recruiting 1406 infants met inclusion criteria. Death before hospital discharge occurred in 85 of 736 infants (11.5%) treated with sustained inflation and 62 of 670 infants (9.3%) who received standard therapy for a risk difference of 3.6% (95% CI, -0.7% to 7.9%). Although analysis of the primary outcome identified important heterogeneity based on gestational age subgroups, the 95% CI for the risk difference included 0 for each individual gestational age subgroup. There was no difference in the primary outcome between subgroups based on study design. Sustained inflation was associated with increased risk of death in the first 2 days after birth (risk difference, 3.1%; 95% CI, 0.9%-5.3%). No differences in the risk of other secondary outcomes were identified. The quality-of-evidence assessment was low owing to risk of bias and imprecision.

Conclusions And Relevance: There was no difference in the risk of the primary outcome of death before hospital discharge, and there was no evidence of efficacy for sustained inflation to prevent secondary outcomes. These findings do not support the routine use of sustained inflation for preterm infants after birth.
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http://dx.doi.org/10.1001/jamapediatrics.2019.5897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7042947PMC
April 2020

Comparison between two ocular cleansing modalities in a population of newborns admitted to Neonatal Intensive Care Unit with clinical signs of conjunctivitis: a randomized controlled trial.

Minerva Pediatr 2019 Dec;71(6):500-504

Neonatal Intensive Care Unit, V. Buzzi Children's Hospital, ASST-FBF-Sacco, Milan, Italy -

Background: Neonatal conjunctivitis is frequent and could benefit from daily cleansing with saline. Anyway super infections can occur and therefore antibiotics are frequently needed. Recently alternative therapies (e.g. Echinacea angustifolia) are used for neonatal conjunctivitis to try to reduce antibiotics therapy. The aim of the study was to verify if the use of gauze containing Echinacea angustifolia compared to standard sodium-chloride at the onset of conjunctivitis symptoms is effective in reducing the clinical symptoms and the risk for superinfections.

Methods: The study was randomized and controlled. Neonates admitted in a tertiary level Neonatal Intensive Care Unit (NICU), with clinical signs of conjunctivitis during hospital stay, were randomized in two groups: group A (3 times daily ocular cleansing for 48 h with sterile gauze; group B (3 times daily ocular cleansing for 48 h with Iridium® baby gauze (Neoox) containing Echinacea angustifolia and pineapple sativus). An eye swab for cultural analysis was taken at time of presentation (T0) prior to treatment and at the end of ocular cleansing (T1).

Results: Sixty-three neonates were enrolled (GrA=30 and GrB=33). At T0, eye specimen positivity was found in 16/30 (48%) in group A and in 18/33 (55%) in group B (P=0.9). No statistical differences among groups at T0 regarding culture positivity. After 48 h, babies in Gr A have significantly fewer positive swabs compared to group B (group A: 18/29, group B: 10/32; P=0.009). Neonates in group B who had negative swab at T0 had a significantly reduced risk to have positive culture at T1 (OR 0.28, CI: 0.10-0,80, P=0.01), also considering confounding factors (birth weight, gestational age, mode of delivery) (adjusted OR 0.15, CI: 0.03-0.52, P<0.01). No differences in regard to antibiotic needs (P=0.95) during the course of conjunctivitis between groups.

Conclusions: Our data suggest that these gauzes containing Echinacea angustifolia might help in avoiding super-infections, contaminations and in reducing ocular bacterial load.
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http://dx.doi.org/10.23736/S0026-4946.19.05659-7DOI Listing
December 2019

Dynamic touch reduces physiological arousal in preterm infants: A role for c-tactile afferents?

Dev Cogn Neurosci 2019 10 21;39:100703. Epub 2019 Aug 21.

Research Centre for Brain & Behaviour, School of Natural Sciences & Psychology, Liverpool John Moores University, UK.

Preterm birth is a significant risk factor for a range of long-term health problems and developmental disabilities. Though touch plays a central role in many perinatal care strategies, the neurobiological basis of these approaches is seldom considered. C-Tactile afferents (CTs) are a class of unmyelinated nerve fibre activated by low force, dynamic touch. Consistent with an interoceptive function, touch specifically targeted to activate CTs activates posterior insular cortex and has been reported to reduce autonomic arousal. The present study compared the effect of 5 min of CT optimal velocity stroking touch to 5 min of static touch on the heart-rate and oxygen saturation levels of preterm infants between 28- & 37-weeks gestational age. CT touch produced a significant decrease in infants' heart-rates and increase in their blood oxygenation levels, which sustained throughout a 5-min post-touch period. In contrast, there was no significant change in heart-rate or blood oxygenation levels of infants receiving static touch. These findings provide support for the hypothesis that CTs signal the affective quality of nurturing touch, providing a neurobiological substrate for the apparent beneficial effects of neonatal tactile interventions and offering insight for their optimisation.
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http://dx.doi.org/10.1016/j.dcn.2019.100703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969366PMC
October 2019

Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial.

Nutrients 2019 Jul 5;11(7). Epub 2019 Jul 5.

Pediatrics Department, Reina Sofia University Hospital, Maimonides Institute for Biomedical research, CIBERER, 14004 Cordoba, Spain.

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.
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http://dx.doi.org/10.3390/nu11071530DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683277PMC
July 2019

Effects of Sustained Inflation or Positive Pressure Ventilation on the Release of Adrenomedullin in Preterm Infants with Respiratory Failure at Birth.

Am J Perinatol 2019 07 25;36(S 02):S110-S114. Epub 2019 Jun 25.

Neonatal Intensive Care Unit, G. D'Annunzio University of Chieti, Chieti, Italy.

Objective: Delivery room (DR) management may play an important role in the development and prevention of lung injury. Therefore, in a cohort of low birth weight infants (LBW), we investigated the effects of two different lung recruitment maneuvers, such as positive pressure ventilation (PPV) and sustained inflation (SI) on adrenomedullin (AM), a well-established lung-specific vasoactive agent.

Study Design: This is a prospective case-control randomized study in 44 LBW infants spontaneously breathing with respiratory failure at birth requiring respiratory support. LBW were randomized to receive PPV ( = 22) or SI ( = 22) support. AM was measured from blood in samples collected at birth from arterial artery (BLT0) and at 1-hour (BLT1) and at 24-hour (BLT2) from peripheral venous site. AM assessment in urine samples was performed at 1-hour (URT1) and at 24-hour (URT2).

Results: No significant differences in AM ( > 0.05) blood (T0-T2) and urine (T1, T2) levels were observed between groups.

Conclusion: The present data, showing the absence of any differences in AM blood and urine levels, suggest that PPV and SI are both feasible and equally effective DR maneuvers. The findings open the way to further studies evaluating the effects of PPV and SI on short-/long-term respiratory outcome through biomarkers assessment.
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http://dx.doi.org/10.1055/s-0039-1692133DOI Listing
July 2019

Patent ductus arteriosus in preterm infants born at 23-24 weeks' gestation: Should we pay more attention?

Early Hum Dev 2019 08 15;135:16-22. Epub 2019 Jun 15.

Clinical Trials Coordinating Center, Careggi University Hospital of Florence, Florence, Italy.

Background: Infants born at 23-24 weeks' gestation have the highest risk of developing a hemodynamically significant patent ductus arteriosus (hsPDA), that is refractory to pharmacological closure requiring surgical ligation. Thus, these patients might have the greatest benefits from hsPDA closure, although previous studies on PDA closure were not focused on this population.

Aim: To compare the occurrence of hsPDA, failure rate of the first course of ibuprofen in closing hsPDA, and need of surgical closure in infants born at 23-24 weeks' gestation to those in infants born at 25-28 weeks' gestation.

Study Design: This is a retrospective multicenter study including infants born at 23-28 weeks of gestation admitted to the neonatal care units from January 2013 to December 2017. All infants underwent echocardiographical assessment for hsPDA diagnosis and eventually pharmacological treatment, and surgical closure.

Results: We studied a total of 842 infants of which 562 (67%) developed a PDA. Among those with PDA, 511 (91%) received a pharmacological treatment for a hsPDA. We found that a hsPDA occurred in 70% (106/151) of infants born at 23-24 weeks and in 59% (405/691) of infants born at 25-28 weeks of gestation (P < 0.001). Failure of closure with the first-treatment cycle (69 vs. 40%; P < 0.001) and need of surgical closure (19 vs 10%) were more frequent (P < 0.011) in infants born at 23-24 than 25-28 gestational weeks. Paracetamol vs. ibuprofen treatment and gestational age of 23-24 versus 25-28 weeks increased closure failure, while less severe RDS and maternal clinical chorioamnionitis decreased it.

Conclusions: Among extremely preterm infants, infants born at 23-24 weeks of gestation have the highest risk of developing a hsPDA refractory to pharmacological treatment requiring surgical closure. Our findings support the need of individualized more careful strategies for hsPDA management in this special population.
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http://dx.doi.org/10.1016/j.earlhumdev.2019.06.002DOI Listing
August 2019

Stress and feelings in mothers and fathers in NICU: identifying risk factors for early interventions.

Prim Health Care Res Dev 2019 06 7;20:e81. Epub 2019 Jun 7.

NICU, Ospedale dei Bambini V. Buzzi, ASST Fatebenefratelli-Sacco, Milano, Italy.

Aims: The aims of this study were to explore parents' stress levels and negative feelings after premature births and to identify the risk factors related to parents' stress and negative feelings during their children's neonatal intensive care unit (NICU) stay.

Background: Preterm birth is a multi-problematic event that may put the babies in danger for both their medical and neurophysiological conditions and could have a negative impact on both the mother-father relationship and the parent-child interactions.

Methods: The study involved 43 mothers and 38 fathers of preterm infants. All participants filled out the Parental Stressor Scale: Neonatal Intensive Care Unit and the Profile of Mood States.

Findings: The results revealed significant differences between mothers' and fathers' responses to preterm births in terms of both stress and negative feelings. We found that, for mothers, their own young age and the baby's need for respiratory support were significant predictors of stress; for fathers, their own young age and the baby's lower gestational age and worse condition at birth were significant predictors of stress and negative feelings. The NICU may be a stressful place both for mothers and fathers. Identifying which mothers and fathers are at risk immediately after their children are born could help to direct specific interventions that can reduce these parents' stress and prevent them from negative feelings.
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http://dx.doi.org/10.1017/S1463423619000021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6567892PMC
June 2019

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

JAMA 2019 03;321(12):1165-1175

Division of Neonatology, Department of Pediatrics, Loma Linda University, Loma Linda, California.

Importance: Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations.

Objective: To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants.

Design, Setting, And Participants: Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes.

Interventions: The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H2O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211).

Main Outcome And Measures: The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours.

Results: Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, -3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups.

Conclusions And Relevance: Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions.

Trial Registration: clinicaltrials.gov Identifier: NCT02139800.
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http://dx.doi.org/10.1001/jama.2019.1660DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6439695PMC
March 2019

Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial.

Trials 2019 Mar 20;20(1):178. Epub 2019 Mar 20.

Centre for the Studies of Asphyxia and Resuscitation, Neonatal Research Unit, Royal Alexandra Hospital, Kingsway Avenue 10240, Edmonton, T5H 3V9, Alberta, Canada.

Background: Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury. The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15 min) in addition to the routine monitoring of arterial oxygen saturation (SpO) and heart rate (HR).

Methods/design: COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these. The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO, SpO, and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15 min after birth during the immediate transition period and resuscitation. Thereafter, each neonate will be followed up for primary outcome to term date or discharge. The primary outcome is mortality or cerebral injury (or both) defined as any intra-ventricular bleeding or cystic periventricular leukomalacia (or both). Secondary outcomes are neonatal morbidities.

Discussion: crSO monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury.

Trial Registration: ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.
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http://dx.doi.org/10.1186/s13063-019-3258-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6427901PMC
March 2019
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