Publications by authors named "Neena Modi"

183 Publications

Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score-matched observational study.

Arch Dis Child Fetal Neonatal Ed 2021 Nov 18. Epub 2021 Nov 18.

Department of Neonatal Medicine, Imperial College London, London, UK.

Objective: To evaluate the impact of timing of initiation of parenteral nutrition (PN) after birth in very preterm infants.

Design: Propensity-matched analysis of data from the UK National Neonatal Research Database.

Patients: 65 033 babies <31 weeks gestation admitted to neonatal units in England and Wales between 2008 and 2019.

Interventions: PN initiated in the first 2 days (early) versus after the second postnatal day (late). Babies who died in the first 2 days without receiving PN were analysed as 'late'.

Main Outcome Measures: The main outcome measure was morbidity-free survival to discharge. The secondary outcomes were survival to discharge, growth and other core neonatal outcomes.

Findings: No difference was found in the primary outcome (absolute rate difference (ARD) between early and late 0.50%, 95% CI -0.45 to 1.45, p=0.29). The early group had higher rates of survival to discharge (ARD 3.3%, 95% CI 2.7 to 3.8, p<0.001), late-onset sepsis (ARD 0.84%, 95% CI 0.48 to 1.2, p<0.001), bronchopulmonary dysplasia (ARD 1.24%, 95% CI 0.30 to 2.17, p=0.01), treated retinopathy of prematurity (ARD 0.50%, 95% CI 0.17 to 0.84, p<0.001), surgical procedures (ARD 0.80%, 95% CI 0.20 to 1.40, p=0.01) and greater drop in weight z-score between birth and discharge (absolute difference 0.019, 95% CI 0.003 to 0.035, p=0.02). Of 4.9% of babies who died in the first 2 days, 3.4% were in the late group and not exposed to PN.

Conclusions: Residual confounding and survival bias cannot be excluded and justify the need for a randomised controlled trial powered to detect differences in important functional outcomes.
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http://dx.doi.org/10.1136/archdischild-2021-322383DOI Listing
November 2021

Five-minute Apgar score and outcomes in neonates of 24-28 weeks' gestation.

Arch Dis Child Fetal Neonatal Ed 2021 Nov 15. Epub 2021 Nov 15.

Division of Neonatology and Pediatrics, Ospedale Versilia, Viareggio, Azienda USL Toscana Nord Ovest, Italy.

Objectives: To assess associations between 5 min Apgar score and mortality and severe neurological injury (SNI) and to report test characteristics in preterm neonates.

Design, Setting And Patients: Retrospective cohort study of neonates 24 to 28 weeks' gestation born between 2007 and 2016 and admitted to neonatal units in 11 high-income countries.

Exposure: 5 min Apgar score.

Main Outcome Measures: In-hospital mortality and SNI defined as grade 3 or 4 periventricular/intraventricular haemorrhage or periventricular leukomalacia. Outcome rates were calculated for each Apgar score and compared after adjustment. The diagnostic characteristics and ORs for each value from 0 versus 1-10 to 0-9 versus 10, with 1-point increments were calculated.

Results: Among 92 412 included neonates, as 5 min Apgar score increased from 0 to 10, mortality decreased from 60% to 8%. However, no clear increasing or decreasing pattern was identified for SNI. There was an increase in sensitivity and decrease in specificity for both mortality and SNI associated with increasing scores. The Apgar score alone had an area under the curve of 0.64 for predicting mortality, which increased to 0.73 with the addition of gestational age.

Conclusions: In neonates of 24-28 weeks' gestation admitted to neonatal units, higher 5 min Apgar score was associated with lower mortality in a graded manner, while the association with SNI remained relatively constant at all scores. Among survivors, low Apgar scores did not predict SNI.
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http://dx.doi.org/10.1136/archdischild-2021-322230DOI Listing
November 2021

Covid-19 treatments and vaccines must be evaluated in pregnancy.

BMJ 2021 10 14;375:n2377. Epub 2021 Oct 14.

Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, UK.

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http://dx.doi.org/10.1136/bmj.n2377DOI Listing
October 2021

Changes in neonatal admissions, care processes and outcomes in England and Wales during the COVID-19 pandemic: a whole population cohort study.

BMJ Open 2021 10 1;11(10):e054410. Epub 2021 Oct 1.

Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK

Objectives: The COVID-19 pandemic instigated multiple societal and healthcare interventions with potential to affect perinatal practice. We evaluated population-level changes in preterm and full-term admissions to neonatal units, care processes and outcomes.

Design: Observational cohort study using the UK National Neonatal Research Database.

Setting: England and Wales.

Participants: Admissions to National Health Service neonatal units from 2012 to 2020.

Main Outcome Measures: Admissions by gestational age, ethnicity and Index of Multiple Deprivation, and key care processes and outcomes.

Methods: We calculated differences in numbers and rates between April and June 2020 (spring), the first 3 months of national lockdown (COVID-19 period), and December 2019-February 2020 (winter), prior to introduction of mitigation measures, and compared them with the corresponding differences in the previous 7 years. We considered the COVID-19 period highly unusual if the spring-winter difference was smaller or larger than all previous corresponding differences, and calculated the level of confidence in this conclusion.

Results: Marked fluctuations occurred in all measures over the 8 years with several highly unusual changes during the COVID-19 period. Total admissions fell, having risen over all previous years (COVID-19 difference: -1492; previous 7-year difference range: +100, +1617; p<0.001); full-term black admissions rose (+66; -64, +35; p<0.001) whereas Asian (-137; -14, +101; p<0.001) and white (-319; -235, +643: p<0.001) admissions fell. Transfers to higher and lower designation neonatal units increased (+129; -4, +88; p<0.001) and decreased (-47; -25, +12; p<0.001), respectively. Total preterm admissions decreased (-350; -26, +479; p<0.001). The fall in extremely preterm admissions was most marked in the two lowest socioeconomic quintiles.

Conclusions: Our findings indicate substantial changes occurred in care pathways and clinical thresholds, with disproportionate effects on black ethnic groups, during the immediate COVID-19 period, and raise the intriguing possibility that non-healthcare interventions may reduce extremely preterm births.
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http://dx.doi.org/10.1136/bmjopen-2021-054410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8488283PMC
October 2021

Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks' gestation: a propensity score matched observational study.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 21. Epub 2021 Sep 21.

Neonatal Medicine, Imperial College London, London, UK.

Objective: To evaluate whether in preterm neonates parenteral nutrition use in the first 7 postnatal days, compared with no parenteral nutrition use, is associated with differences in survival and other important morbidities. Randomised trials in critically ill older children show that harms, such as nosocomial infection, outweigh benefits of early parenteral nutrition administration; there is a paucity of similar data in neonates.

Design: Retrospective cohort study using propensity matching including 35 maternal, infant and organisational factors to minimise bias and confounding.

Setting: National, population-level clinical data obtained for all National Health Service neonatal units in England and Wales.

Patients: Preterm neonates born between 30 and 32 weeks.

Interventions: The exposure was parenteral nutrition administered in the first 7 days of postnatal life; the comparator was no parenteral nutrition.

Main Outcome Measures: The primary outcome was survival to discharge from neonatal care. Secondary outcomes comprised the neonatal core outcome set.

Results: 16 292 neonates were compared in propensity score matched analyses. Compared with matched neonates not given parenteral nutrition in the first postnatal week, neonates who received parenteral nutrition had higher survival at discharge (absolute rate increase 0.91%; 95% CI 0.53% to 1.30%), but higher rates of necrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia (absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) and need for surgical procedures (absolute rate increase 0.92%).

Conclusions: In neonates born between 30 and 32 weeks' gestation, those given parenteral nutrition in the first postnatal week had a higher rate of survival but higher rates of important neonatal morbidities. Clinician equipoise in this area should be resolved by prospective randomised trials.

Trial Registration Number: NCT03767634.
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http://dx.doi.org/10.1136/archdischild-2021-321643DOI Listing
September 2021

Birthweight and patterns of postnatal weight gain in very and extremely preterm babies in England and Wales, 2008-19: a cohort study.

Lancet Child Adolesc Health 2021 10 25;5(10):719-728. Epub 2021 Aug 25.

School of Public Health, Faculty of Medicine, Imperial College London, London, UK; Section of Neonatal Medicine, Chelsea and Westminster Hospital, London, UK. Electronic address:

Background: Intrauterine and postnatal weight are widely regarded as biomarkers of fetal and neonatal wellbeing, but optimal weight gain following preterm birth is unknown. We aimed to describe changes over time in birthweight and postnatal weight gain in very and extremely preterm babies, in relation to major morbidity and healthy survival.

Methods: In this cohort study, we used whole-population data from the UK National Neonatal Research Database for infants below 32 weeks gestation admitted to neonatal units in England and Wales between Jan 1, 2008, and Dec 31, 2019. We used non-linear Gaussian process to estimate monthly trends, and Bayesian multilevel regression to estimate unadjusted and adjusted coefficients. We evaluated birthweight; weight change from birth to 14 days; weight at 36 weeks postmenstrual age; associated Z scores; and longitudinal weights for babies surviving to 36 weeks postmenstrual age with and without major morbidities. We adjusted birthweight for antenatal, perinatal, and demographic variables. We additionally adjusted change in weight at 14 days and weight at 36 weeks postmenstrual age, and their Z scores, for postnatal variables.

Findings: The cohort comprised 90 817 infants. Over the 12-year period, mean differences adjusted for antenatal, perinatal, demographic, and postnatal variables were 0 g (95% compatibility interval -7 to 7) for birthweight (-0·01 [-0·05 to 0·03] for change in associated Z score); 39 g (26 to 51) for change in weight from birth to 14 days (0·14 [0·08 to 0·19] for change in associated Z score); and 105 g (81 to 128) for weight at 36 weeks postmenstrual age (0·27 [0·21 to 0·33] for change in associated Z score). Greater weight at 36 weeks postmenstrual age was robust to additional adjustment for enteral nutritional intake. In babies surviving without major morbidity, weight velocity in all gestational age groups stabilised at around 34 weeks postmenstrual age at 16-25 g per day along parallel percentile lines.

Interpretation: The birthweight of very and extremely preterm babies has remained stable over 12 years. Early postnatal weight loss has decreased, and subsequent weight gain has increased, but weight at 36 weeks postmenstrual age is consistently below birth percentile. In babies without major morbidity, weight velocity follows a consistent trajectory, offering opportunity to construct novel preterm growth curves despite lack of knowledge of optimal postnatal weight gain.

Funding: UK Medical Research Council.
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http://dx.doi.org/10.1016/S2352-4642(21)00232-7DOI Listing
October 2021

Future Research in Preterm Nutrition.

Authors:
Neena Modi

World Rev Nutr Diet 2021 5;122:357-366. Epub 2021 Aug 5.

Section of Neonatal Medicine, Faculty of Medicine, Imperial College London, London, United Kingdom.

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http://dx.doi.org/10.1159/000514765DOI Listing
August 2021

Incorporating parent, former patient and clinician perspectives in the design of a national UK double-cluster, randomised controlled trial addressing uncertainties in preterm nutrition.

BMJ Paediatr Open 2021 15;5(1):e001112. Epub 2021 Jun 15.

Section of Neonatal Medicine, Imperial College London, London, UK.

Background: Comparative effectiveness randomised controlled trials are powerful tools to resolve uncertainties in existing treatments and care processes. We sought parent and patient perspectives on the design of a planned national, double-cluster randomised controlled trial (COLLABORATE) to resolve two longstanding uncertainties in preterm nutrition.

Methods: We used qualitative focus groups and interviews with parents, former patients and clinicians. We followed the Consolidated Criteria for Reporting Qualitative Research checklist and conducted framework analysis, a specific methodology within thematic analysis.

Results: We identified support for the trial's methodology and vision, and elicited themes illustrating parents' emotional needs in relation to clinical research. These were: relieving the pressure on mothers to breastfeed; opt-out consent as reducing parent stress; the desire for research to be a partnership between clinicians, parents and researchers; the value of presenting trial information in a collaborative tone; and in a format that allows assimilation by parents at their own pace. We identified anxiety and cognitive dissonance among some clinicians in which they recognised the uncertainties that justify the trial but felt unable to participate because of their strongly held views.

Conclusions: The early involvement of parents and former patients identified the centrality of parents' emotional needs in the design of comparative effectiveness research. These insights have been incorporated into trial enrolment processes and information provided to participants. Specific outputs were a two-sided leaflet providing very brief as well as more detailed information, and use of language that parents perceive as inclusive and participatory. Further work is warranted to support clinicians to address personal biases that inhibit trial participation.
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http://dx.doi.org/10.1136/bmjpo-2021-001112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8208018PMC
June 2021

Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group.

Pediatr Res 2021 Jun 7. Epub 2021 Jun 7.

Department of Pharmacology and Toxicology, Radboud Institute for Health Sciences, Radboudumc, Nijmegen, The Netherlands.

Background: The COVID-19 pandemic has had a devastating impact on multiple aspects of healthcare, but has also triggered new ways of working, stimulated novel approaches in clinical research and reinforced the value of previous innovations. Conect4children (c4c, www.conect4children.org ) is a large collaborative European network to facilitate the development of new medicines for paediatric populations, and is made up of 35 academic and 10 industry partners from 20 European countries, more than 50 third parties, and around 500 affiliated partners.

Methods: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equity.

Findings: We summarise aspects of clinical research in paediatrics stimulated and reinforced by COVID-19 that the Conect4children group recommends regulators, sponsors, and investigators retain for the future, to enhance the efficiency, reduce the cost and burden of medicines and non-interventional studies, and deliver research-equityWe provide examples of research innovation, and follow this with recommendations to improve the efficiency of future trials, drawing on industry perspectives, regulatory considerations, infrastructure requirements and parent-patient-public involvement. We end with a comment on progress made towards greater international harmonisation of paediatric research and how lessons learned from COVID-19 studies might assist in further improvements in this important area.
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http://dx.doi.org/10.1038/s41390-021-01587-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184051PMC
June 2021

Cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocol.

BMJ Open 2021 05 4;11(5):e050452. Epub 2021 May 4.

Edinburgh Clinical Trials Unit (ECTU) Usher Institute, University of Edinburgh, Edinburgh, UK.

Introduction: The aim of the cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS).

Methods And Analysis: We will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks' gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost-utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained.

Research Ethics Approval And Dissemination: CHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals.

Trial Registration Number: ISRCTN32652461.
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http://dx.doi.org/10.1136/bmjopen-2021-050452DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8098973PMC
May 2021

Consent and the continuing evolution of clinical research ethics.

Authors:
Neena Modi

Arch Dis Child Fetal Neonatal Ed 2021 May;106(3):230-231

School of Public Health, Imperial College London, London, UK

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http://dx.doi.org/10.1136/archdischild-2020-320970DOI Listing
May 2021

Health of women and children is central to covid-19 recovery.

BMJ 2021 04 14;373:n899. Epub 2021 Apr 14.

Imperial College London, Chelsea and Westminster campus, London SW10 9NH, UK

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http://dx.doi.org/10.1136/bmj.n899DOI Listing
April 2021

Identification of variation in nutritional practice in neonatal units in England and association with clinical outcomes using agnostic machine learning.

Sci Rep 2021 03 30;11(1):7178. Epub 2021 Mar 30.

NIHR Imperial Biomedical Research Centre, ITMAT Data Science Group, Imperial College London, London, UK.

We used agnostic, unsupervised machine learning to cluster a large clinical database of information on infants admitted to neonatal units in England. Our aim was to obtain insights into nutritional practice, an area of central importance in newborn care, utilising the UK National Neonatal Research Database (NNRD). We performed clustering on time-series data of daily nutritional intakes for very preterm infants born at a gestational age less than 32 weeks (n = 45,679) over a six-year period. This revealed 46 nutritional clusters heterogeneous in size, showing common interpretable clinical practices alongside rarer approaches. Nutritional clusters with similar admission profiles revealed associations between nutritional practice, geographical location and outcomes. We show how nutritional subgroups may be regarded as distinct interventions and tested for associations with measurable outcomes. We illustrate the potential for identifying relationships between nutritional practice and outcomes with two examples, discharge weight and bronchopulmonary dysplasia (BPD). We identify the well-known effect of formula milk on greater discharge weight as well as support for the plausible, but insufficiently evidenced view that human milk is protective against BPD. Our framework highlights the potential of agnostic machine learning approaches to deliver clinical practice insights and generate hypotheses using routine data.
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http://dx.doi.org/10.1038/s41598-021-85878-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8009880PMC
March 2021

The implications of routine milk fortification for the short and long-term health of preterm babies.

Authors:
Neena Modi

Semin Fetal Neonatal Med 2021 06 25;26(3):101216. Epub 2021 Feb 25.

Imperial College London, Chelsea and Westminster Hospital campus, 369 Fulham Road, London, SW10 9NH, UK. Electronic address:

Fortification refers to the practice of enriching human milk feeds for very preterm babies with macronutrients, minerals and vitamins. Though standard of care in some parts of the world, adoption of fortification is not universal. Fortification entered into use on the assumption that human milk macronutrient content, principally protein, is insufficient to support the growth and development of very preterm babies. However, because of the substantial variability in human milk composition, routine fortification risks exposing some babies to very high protein intakes, which may be dangerous. Some clinicians fear fortification with cow-milk derived products will increase the risk of necrotising enterocolitis, leading them to favour commercial fortifiers made from pooled human milk over cow milk based products, a practice that has additional ethical implications. Randomised controlled trials of multi-nutrient fortification to-date are inadequate. No trial has had power to detect important functional effects; the majority are methodologically weak and focus primarily upon short-term growth. Evidence to guide practice is inadequate. There is an urgent need for collaboration to conduct high-quality research to end these long-standing uncertainties.
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http://dx.doi.org/10.1016/j.siny.2021.101216DOI Listing
June 2021

Racial microaggressions within respiratory and critical care medicine.

Lancet Respir Med 2021 03 2;9(3):e27-e28. Epub 2021 Mar 2.

King's College Hospital NHS Foundation Trust, London SE5 9RS, UK; Institute for Women's and Children's Health, King's College London, London, UK. Electronic address:

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http://dx.doi.org/10.1016/S2213-2600(21)00001-1DOI Listing
March 2021

Variations in Neonatal Length of Stay of Babies Born Extremely Preterm: An International Comparison Between iNeo Networks.

J Pediatr 2021 06 15;233:26-32.e6. Epub 2021 Feb 15.

UK Neonatal Collaborative, Neonatal Data Analysis Unit, Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.

Objective: To compare length of stay (LOS) in neonatal care for babies born extremely preterm admitted to networks participating in the International Network for Evaluating Outcomes of Neonates (iNeo).

Study Design: Data were extracted for babies admitted from 2014 to 2016 and born at 24 to 28 weeks of gestational age (n = 28 204). Median LOS was calculated for each network for babies who survived and those who died while in neonatal care. A linear regression model was used to investigate differences in LOS between networks after adjusting for gestational age, birth weight z score, sex, and multiplicity. A sensitivity analysis was conducted for babies who were discharged home directly.

Results: Observed median LOS for babies who survived was longest in Japan (107 days); this result persisted after adjustment (20.7 days more than reference, 95% CI 19.3-22.1). Finland had the shortest adjusted LOS (-4.8 days less than reference, 95% CI -7.3 to -2.3). For each week's increase in gestational age at birth, LOS decreased by 12.1 days (95% CI -12.3 to -11.9). Multiplicity and male sex predicted mean increases in LOS of 2.6 (95% CI 2.0-3.2) and 2.1 (95% CI 1.6-2.6) days, respectively.

Conclusions: We identified between-network differences in LOS of up to 3 weeks for babies born extremely preterm. Some of these may be partly explained by differences in mortality, but unexplained variations also may be related to differences in clinical care practices and healthcare systems between countries.
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http://dx.doi.org/10.1016/j.jpeds.2021.02.015DOI Listing
June 2021

Facilitating quality improvement through routinely recorded clinical information.

Authors:
Neena Modi

Semin Fetal Neonatal Med 2021 02 29;26(1):101195. Epub 2021 Jan 29.

Professor of Neonatal Medicine, Imperial College London, Chelsea and Westminster Hospital Campus, 369 Fulham Road, London, SW10 9NH, UK. Electronic address:

In this chapter, I discuss how quality improvement activities can be facilitated using routinely available clinical data. I begin by providing a definition of quality improvement and quality healthcare, and identifying what I consider key components and their information requirements. I suggest that quality improvement can be made simpler, more efficient and less labour and resource intensive by focussing on outcomes. Finally, I provide pointers for developing resources of routinely available clinical information.
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http://dx.doi.org/10.1016/j.siny.2021.101195DOI Listing
February 2021

Changing clinical characteristics of infants treated for hypoxic-ischaemic encephalopathy in England, Wales and Scotland: a population-based study using the National Neonatal Research Database.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 4;106(5):501-508. Epub 2021 Feb 4.

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London Faculty of Medicine, London, UK

Background: Therapeutic hypothermia is standard of care for babies with moderate/severe hypoxic-ischaemic encephalopathy and is increasingly used for mild encephalopathy.

Objective: Describe temporal trends in the clinical condition of babies diagnosed with hypoxic-ischaemic encephalopathy who received therapeutic hypothermia.

Design: Retrospective cohort study using data held in the National Neonatal Research Database.

Setting: National Health Service neonatal units in England, Wales and Scotland.

Patients: Infants born from 1 January 2010 to 31 December 2017 with a recorded diagnosis of hypoxic-ischaemic encephalopathy who received therapeutic hypothermia for at least 3 days or died in this period.

Main Outcomes: Primary outcomes: recorded clinical characteristics including umbilical cord pH; Apgar score; newborn resuscitation; seizures and treatment on day 1.

Secondary Outcomes: recorded hypoxic-ischaemic encephalopathy grade.

Results: 5201 babies with a diagnosis of hypoxic-ischaemic encephalopathy received therapeutic hypothermia or died; annual numbers increased over the study period. A decreasing proportion had clinical characteristics of severe hypoxia ischaemia or a diagnosis of moderate or severe hypoxic-ischaemic encephalopathy, trends were statistically significant and consistent across multiple clinical characteristics used as markers of severity.

Conclusions: Treatment with therapeutic hypothermia for hypoxic-ischaemic encephalopathy has increased in England, Scotland and Wales. An increasing proportion of treated infants have a diagnosis of mild hypoxic-ischaemic encephalopathy or have less severe clinical markers of hypoxia. This highlights the importance of determining the role of hypothermia in mild hypoxic-ischaemic encephalopathy. Receipt of therapeutic hypothermia is unlikely to be a useful marker for assessing changes in the incidence of brain injury over time.
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http://dx.doi.org/10.1136/archdischild-2020-319685DOI Listing
September 2021

Inter-center variability in neonatal outcomes of preterm infants: A longitudinal evaluation of 298 neonatal units in 11 countries.

Semin Fetal Neonatal Med 2021 02 21;26(1):101196. Epub 2021 Jan 21.

Department of Pediatrics and Maternal-infant Care Research Centre, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario, Canada, M5G 1X5. Electronic address:

Collaboration and cooperation of clinicians and neonatal units at regional, national, and international levels are key features of many networks or systems that aim to improve neonatal outcomes. Network performance is typically assessed by comparing individual, unit-level outcomes. In this paper, we provide insight into another dimension, i.e., inter-center outcome variation in 10 national/regional neonatal collaborations from 11 high-income countries. We illustrate the use of coefficients of variation for evaluation of mortality and a composite outcome of mortality, severe neurological injury, treated retinopathy of prematurity, and bronchopulmonary dysplasia, as a measure of inter-center variation. These inter-center variation estimates could help to identify areas of opportunities and challenges for each country/region; they also provide "macro"-level evaluations that can be useful for clinicians, administrators, managers and policy makers.
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http://dx.doi.org/10.1016/j.siny.2021.101196DOI Listing
February 2021

Post-COVID economic recovery: women and children first … or last?

Arch Dis Child 2021 Jan 27. Epub 2021 Jan 27.

Institute of Developmental Sciences and NIHR Biomedical Research Centre, University of Southampton School of Medicine, Southampton, UK.

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http://dx.doi.org/10.1136/archdischild-2020-320898DOI Listing
January 2021

Equity in coronavirus disease 2019 vaccine development and deployment.

Am J Obstet Gynecol 2021 05 15;224(5):423-427. Epub 2021 Jan 15.

Department of Obstetrics and Gynaecology, School of Medicine, University of Buenos Aires, Buenos Aires, Argentina.

The coronavirus disease 2019 pandemic exposed weaknesses in multiple domains and widened gender-based inequalities across the world. It also stimulated extraordinary scientific achievement by bringing vaccines to the public in less than a year. In this article, we discuss the implications of current vaccination guidance for pregnant and lactating women, if their exclusion from the first wave of vaccine trials was justified, and if a change in the current vaccine development pathway is necessary. Pregnant and lactating women were not included in the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. Therefore, perhaps unsurprisingly, the first vaccine regulatory approvals have been accompanied by inconsistent advice from public health, governmental, and professional authorities around the world. Denying vaccination to women who, although pregnant or breastfeeding, are fully capable of autonomous decision making is a throwback to a paternalistic era. Conversely, lack of evidence generated in a timely manner, upon which to make an informed decision, shifts responsibility from research sponsors and regulators and places the burden of decision making upon the woman and her healthcare advisor. The World Health Organization, the Task Force on Research Specific to Pregnant Women and Lactating Women, and others have highlighted the long-standing disadvantage experienced by women in relation to the development of vaccines and medicines. It is uncertain whether there was sufficient justification for excluding pregnant and lactating women from the initial severe acute respiratory syndrome coronavirus 2 vaccine trials. In future, we recommend that regulators mandate plans that describe the development pathway for new vaccines and medicines that address the needs of women who are pregnant or lactating. These should incorporate, at the outset, a careful consideration of the balance of the risks of exclusion from or inclusion in initial studies, patient and public perspectives, details of "developmental and reproductive toxicity" studies, and approaches to collect data systematically from participants who are unknowingly pregnant at the time of exposure. This requires careful consideration of any previous knowledge about the mode of action of the vaccine and the likelihood of toxicity or teratogenicity. We also support the view that the default position should be a "presumption of inclusion," with exclusion of women who are pregnant or lactating only if justified on specific, not generic, grounds. Finally, we recommend closer coordination across countries with the aim of issuing consistent public health advice.
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http://dx.doi.org/10.1016/j.ajog.2021.01.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7810027PMC
May 2021

Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol.

BMJ Open 2020 12 12;10(12):e038959. Epub 2020 Dec 12.

Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.

Introduction: Respiratory distress syndrome is a condition seen in preterm infants primarily due to surfactant insufficiency. European guidelines recommend the dose and method of surfactant administration. However, in routine practice, clinicians often use a 'whole vial' approach to surfactant dosing. The aim of this study is to assess whether in preterm infants of gestational age 36 weeks or less, a low first dose of surfactant (100-130 mg/kg) compared with a high first dose (170-200 mg/kg) affects survival with no mechanical ventilation on either on postnatal days 3 and 4, and other outcomes.

Methods And Analysis: In this prospective, observational study, we will use the National Neonatal Research Database as the main data source. We will obtain additional information describing the dose and method of surfactant administration through the neonatal EPR system. We will use propensity scores to form matched groups with low first dose and high first dose for comparison.

Ethics And Dissemination: This study was approved by the West Midlands-Black Country Research Ethics Committee (REC reference: 18/WM/0132; IRAS project ID: 237111). The results of the research will be made publicly available through presentations at local, national or international conferences and will be submitted for publication in a peer-reviewed journal.

Trial Registration Number: NCT03808402; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-038959DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735095PMC
December 2020

Maternal, neonatal, and child health is essential for meeting SDG 3.4.

Lancet 2020 11 27;396(10264):1731-1732. Epub 2020 Oct 27.

Institute of Developmental Sciences and National Institute of Health Research Biomedical Research Centre, University of Southampton, Southampton, UK; University Hospital Southampton, Southampton, UK. Electronic address:

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http://dx.doi.org/10.1016/S0140-6736(20)32222-4DOI Listing
November 2020

Building resilient societies after COVID-19: the case for investing in maternal, neonatal, and child health.

Lancet Public Health 2020 11 21;5(11):e624-e627. Epub 2020 Sep 21.

Institute of Developmental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK; Southampton NIHR Biomedical Research Centre, Southampton General Hospital, Southampton, UK.

Resilient societies respond rapidly and effectively to health challenges and the associated economic consequences, and adapt to be more responsive to future challenges. Although it is only possible to recognise resilience retrospectively, the COVID-19 pandemic has occurred at a point in human history when, uniquely, sufficient knowledge is available on the early-life determinants of health to indicate clearly that a focus on maternal, neonatal, and child health (MNCH) will promote later resilience. This knowledge offers an unprecedented opportunity to disrupt entrenched strategies and to reinvest in MNCH in the post-COVID-19 so-called new normal. Furthermore, analysis of the short-term, medium-term, and longer-term consequences of previous socioeconomic shocks provides important insights into those domains of MNCH, such as neurocognitive development and nutrition, for which investment will generate the greatest benefit. Such considerations apply to high-income countries (HICs) and low-income and middle-income countries (LMICs). However, implementing appropriate policies in the post-COVID-19 recovery period will be challenging and requires political commitment and public engagement.
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http://dx.doi.org/10.1016/S2468-2667(20)30200-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7505549PMC
November 2020

Pilot study to establish a prospective neonatal cohort: Study of Preterm Infants and Neurodevelopmental Genes (SPRING).

BMJ Paediatr Open 2020 30;4(1):e000648. Epub 2020 Jul 30.

Section of Neonatal Medicine, Imperial College London Department of Medicine, London, UK.

Background: Genetic risk variants and preterm birth are early and potent risk factors for later neuropsychiatric disorders. To understand the interrelationships between these factors, a large-scale genetic study of very preterm (VPT, <32 weeks gestation) infants with prospective follow-up is required. In this paper, we describe a streamlined study approach, using efficient processes for biological and clinical data collection, to feasibly establish such a cohort.

Methods: We sought to recruit 500 VPT families within a 1 year period from neonatal units. Treating clinical teams recruited eligible participants, obtained parent consent, collected blood samples and posted specimens to the research laboratory. We extracted all clinical data from the National Neonatal Research Database, an existing UK resource that captures daily patient-level data on all VPT infants.

Results: Between May 2017 and June 2018, we established a cohort of 848 VPT infants and their parents from 60 English neonatal units. The study population (median (IQR), gestation: 28.9 (26-30) weeks; birth weight: 1120 (886-1420) g) represented 18.9% of eligible infants born at the study sites during the recruitment period (n=4491). From the subset of 521 complete family trios, we successfully completed genotyping for 510 (97.9%) trios. Of the original 883 infants whose parents consented to participate, the parents of 796 (90.1%) infants agreed to future data linkage and 794 (89.9%) agreed to be recalled.

Conclusion: We demonstrate the feasibility and acceptability of streamlined strategies for genetic, neonatal and longitudinal data collection and provide a template for future cost-effective and efficient cohort development.
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http://dx.doi.org/10.1136/bmjpo-2020-000648DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7394180PMC
July 2020

Adult outcomes after preterm birth.

Postgrad Med J 2020 Oct 11;96(1140):619-622. Epub 2020 Aug 11.

Neonatal Medicine, Imperial College London, London, UK.

Extremely preterm birth reflects global disruption of the third trimester environment. Young adults born preterm have an adverse cardiovascular and metabolic health profile, together with molecular evidence of accelerated ageing and a reduced life expectancy. The underlying mechanism for these observations is unknown. This review summarises recent evidence of the lifetime effects of preterm birth and highlights the risks survivors face.
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http://dx.doi.org/10.1136/postgradmedj-2020-137707DOI Listing
October 2020

Review of guidelines and recommendations from 17 countries highlights the challenges that clinicians face caring for neonates born to mothers with COVID-19.

Acta Paediatr 2020 Nov 20;109(11):2192-2207. Epub 2020 Aug 20.

Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Aim: This review examined how applicable national and regional clinical practice guidelines and recommendations for managing neonates born to mothers with COVID-19 mothers were to the evolving pandemic.

Methods: A systematic search and review identified 20 guidelines and recommendations that had been published by May 25, 2020. We analysed documents from 17 countries: Australia, Brazil, Canada, China, France, India, Italy, Japan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, the UK and the United States.

Results: The documents were based on expert consensus with limited evidence and were of variable, low methodological rigour. Most did not provide recommendations for delivery methods or managing symptomatic infants. None provided recommendations for post-discharge assimilation of potentially infected infants into the community. The majority encouraged keeping mothers and infants together, subject to infection control measures, but one-third recommended separation. Although breastfeeding or using breastmilk was widely encouraged, two countries specifically prohibited this.

Conclusion: The guidelines and recommendations for managing infants affected by COVID-19 were of low, variable quality and may be unsustainable. It is important that transmission risks are not increased when new information is incorporated into clinical recommendations. Practice guidelines should emphasise the extent of uncertainty and clearly define gaps in the evidence.
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http://dx.doi.org/10.1111/apa.15495DOI Listing
November 2020

Children first, or last?

Authors:
Neena Modi

EBioMedicine 2020 Jun 4;56:102818. Epub 2020 Jun 4.

Professor of Neonatal Medicine, Imperial College London, London, UK. Electronic address:

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http://dx.doi.org/10.1016/j.ebiom.2020.102818DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276509PMC
June 2020

Neonatal outcomes of extremely preterm twins by sex pairing: an international cohort study.

Arch Dis Child Fetal Neonatal Ed 2021 Jan 25;106(1):17-24. Epub 2020 May 25.

Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.

Objective: Infant boys have worse outcomes than girls. In twins, the 'male disadvantage' has been reported to extend to female co-twins via a 'masculinising' effect. We studied the association between sex pairing and neonatal outcomes in extremely preterm twins.

Design: Retrospective cohort study SETTING: Eleven countries participating in the International Network for Evaluating Outcomes of Neonates.

Patients: Liveborn twins admitted at 23-29 weeks' gestation in 2007-2015.

Main Outcome Measures: We examined in-hospital mortality, grades 3/4 intraventricular haemorrhage or cystic periventricular leukomalacia (IVH/PVL), bronchopulmonary dysplasia (BPD), retinopathy of prematurity requiring treatment and a composite outcome (mortality or any of the outcomes above).

Results: Among 20 924 twins, 38% were from male-male pairs, 32% were from female-female pairs and 30% were sex discordant. We had no information on chorionicity. Girls with a male co-twin had lower odds of mortality, IVH/PVL and the composite outcome than girl-girl pairs (reference group): adjusted OR (aOR) (95% CI) 0.79 (0.68 to 0.92), 0.83 (0.72 to 0.96) and 0.88 (0.79 to 0.98), respectively. Boys with a female co-twin also had lower odds of mortality: aOR 0.86 (0.74 to 0.99). Boys from male-male pairs had highest odds of BPD and composite outcome: aOR 1.38 (1.24 to 1.52) and 1.27 (1.16 to 1.39), respectively.

Conclusions: Sex-related disparities in outcomes exist in extremely preterm twins, with girls having lower risks than boys and opposite-sex pairs having lower risks than same-sex pairs. Our results may help clinicians in assessing risk in this large segment of extremely preterm infants.
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http://dx.doi.org/10.1136/archdischild-2020-318832DOI Listing
January 2021

Improving the Efficiency and Impact of Clinical Research: A Game Changer for 21st Century Neonatology.

Authors:
Neena Modi

Neonatology 2020 25;117(2):207-210. Epub 2020 May 25.

Imperial College London, Chelsea and Westminster Campus, London, United Kingdom,

Every clinician is aware of the many uncertainties that exist in everyday clinical care. These contribute to variation and inequity in outcomes and pose dangers to patient wellbeing and safety. Evidence generation is still too slow, too expensive, too much left to chance, too ad hoc, and wholly inadequate. Modern technologies can drive faster, more efficient evidence generation and implementation of findings. However, professional and public buy-in are also needed for success; in short, a new conceptual framework aimed at reducing uncertainties effectively, efficiently, and incrementally in clinical practice is required. Currently, much-needed research to reduce practice uncertainties is often never done, or conducted in ways that are inefficient or lack impact. The consequence is poor patient care and abrogation of the cardinal duty of doctors to "first, do no harm." Research is efficient if high quality, conducted rapidly, at reasonable cost, with minimal burden on investigators and participants. Research has impact if outcomes are incorporated into evidence syntheses, and robust conclusions are implemented into practice without delay. Here, I will discuss ways that build upon modern thinking and new technologies to improve the efficiency and impact of clinical research.
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http://dx.doi.org/10.1159/000506865DOI Listing
August 2021
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