Publications
370 results found
Modi N, Bhalotra S, Bustreo F, et al., 2022, We must value and safeguard human health for a sustainable future, BMJ-BRITISH MEDICAL JOURNAL, Vol: 379, ISSN: 0959-535X
Modi N, 2022, Message to the new prime minister (whoever this might be), ARCHIVES OF DISEASE IN CHILDHOOD, ISSN: 0003-9888
Yao S, Uthaya S, Gale C, et al., 2022, Postnatal corticosteroid use for prevention or treatment of Bronchopulmonary Dysplasia in England and Wales 2012-2019: a retrospective population cohort study, BMJ Open, Vol: 12, ISSN: 2044-6055
Objective: Describe the population of babies who do and do not receive postnatal corticosteroids for prevention or treatment of bronchopulmonary dysplasia (BPD).Design: Retrospective cohort study using data held in the National Neonatal Research Database.Setting: National Health Service neonatal units in England and Wales.Patients: Babies born less than 32 weeks gestation and admitted to neonatal units from 1 January 2012 to 31 December 2019.Main outcomes: Proportion of babies given postnatal corticosteroid; type of corticosteroid; age at initiation and duration, trends over time.Secondary outcomes: Survival to discharge, treatment for retinopathy of prematurity, BPD, brain injury, severe necrotising enterocolitis, gastrointestinal perforation.Results: 8% (4713/62019) of babies born <32 weeks and 26% (3525/13527) born <27 weeks received postnatal corticosteroids for BPD. Dexamethasone was predominantly used 5.3% (3309/62019), followed by late hydrocortisone 1.5%, inhaled budesonide 1.5%. prednisolone 0.8%, early hydrocortisone 0.3% and methylprednisolone 0.05%. Dexamethasone use increased over time (2012: 4.5 vs 2019: 5.8%, p=0.04). Median postnatal age of initiation of corticosteroid course was around 3 weeks for late hydrocortisone, 4 weeks for dexamethasone, 6 weeks for inhaled budesonide, 12 weeks for prednisolone and 16 weeks for methylprednisolone. Babies who received postnatal corticosteroids were born more prematurely, had a higher incidence of comorbidities and a longer length of stay.Conclusions: In England and Wales, around 1 in 12 babies born less than 32 weeks and 1 in 4 born less than 27 weeks receive postnatal corticosteroids to prevent or treat BPD. Given the lack of convincing evidence of efficacy, challenges of recruiting to and length of time taken to conduct randomised controlled trial, our data highlight the need to monitor long-term outcomes in children who received neonatal postnatal corticosteroids.
Hyde MJ, Jeffries S, McCarthy RL, et al., 2022, Infant body mass index, eczema and atopy at one year of age in relation to mode of delivery, CLINICAL AND EXPERIMENTAL ALLERGY, Vol: 52, Pages: 1351-1354, ISSN: 0954-7894
Modi N, 2022, The future of perinatal research, EUROPEAN JOURNAL OF PEDIATRICS, ISSN: 0340-6199
Sawtell M, van Blankenstein E, Bilal T, et al., 2022, Views of parents, adults born preterm and professionals on linkage of real-world data of preterm babies, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 108, Pages: 194-199, ISSN: 1359-2998
Objective To explore views of parents of preterm babies, adults born preterm and professionals, on the linkage of real-world health and education data for research on improving future outcomes of babies born preterm.Design Three-stage mixed-methods participatory design involving focus groups, a national survey and interviews. Survey participants who expressed uncertainty or negative views were sampled purposively for invitation to interview. Mixed methods were used for data analysis.Setting and participants All data collection was online. Participants were: focus groups—17 parents; survey—499 parents, 44 adults born preterm (total 543); interviews—6 parents, 1 adult born preterm, 3 clinicians, 2 teachers.Results Three key themes were identified: (1) Data linkage and opt-out consent make sense for improving future outcomes. We found clear demand for better information on long-term outcomes and strong support for data linkage with opt-out consent as a means of achieving this. (2) Information requirements—what, how and when. There was support for providing information in different formats and discussing linkage near to, or following discharge from, the neonatal unit, but not sooner. (3) Looking to the future; the rights of young people. We identified a desire for individuals born preterm to be consulted in the future on the use of their data.Conclusion With appropriate information provision, at the right time, parents, adults born preterm and professionals are supportive of data linkage for research, including where temporary identifiers and opt-out consent are used. Resources are being co-produced to improve communication about routine data linkage.
Webbe J, Battersby C, Longford N, et al., 2022, Use of parenteral nutrition in the first postnatal week in England and Wales: An observational study using real-world data, BMJ Paediatrics Open, Vol: 6, ISSN: 2399-9772
BackgroundParenteral nutrition (PN) is used to provide supplemental support to neonates while enteral feeding is being established. PN is a high-cost intervention with beneficial and harmful effects. Internationally there is substantial variation in how PN is used, and there are limited contemporary data describing use across the UK. ObjectiveTo describe PN use in the first postnatal week in infants born and admitted to neonatal care in England, Scotland and Wales.MethodData describing neonates admitted to National Health Service (NHS) neonatal units between 1st January 2012 and 31st December 2017, extracted from routinely recorded data held the National Neonatal Research Database (NNRD); the denominator was live births, from Office for National Statistics.ResultsOver the study period 62,145 neonates were given PN in the first postnatal week (1.4% of all live births); use was higher in more preterm neonates (76% of livebirths at <28 weeks, 0.2% of term livebirths) and in neonates with lower birth weight. 15% (9181/62145) of neonates given PN in the first postnatal week were born at term. There was geographic variation in PN administration: the proportion of live births given PN within neonatal regional networks ranged from 1.0% (95% confidence intervals: 1.0, 1.0) to 2.8% (95% confidence interval: 2.7, 2.9). Conclusions and relevanceSignificant variation exists in neonatal PN use; it is unlikely this reflects optimal use of an expensive intervention. Research is needed to identify which babies will benefit most and which are at risk of harm from early PN. RegistrationClinicalTrials.gov: NCT03767634
Jeffries S, Moss R, Hyde M, et al., 2022, Improving physiological stability of very preterm babies: a preliminary randomised controlled trial, British Journal of Midwifery, Vol: 30, ISSN: 0969-4900
Background:Preterm babies born below 32 weeks gestational age are placed in incubators, therefore deprived of exposure to maternal heartbeat sounds and breathing rhythms. The Babybe is a unique soft-robotics device which replicates these via the Babybe mattress in the incubator.Aims:Obtain data on the experience of mothers who participated in COSYBABY in relation to using the device and learn what, if any, value this device has to parents in the neonatal unit setting.Methods:We used qualitative focus groups conducted by our Patient and Public Involvement (PPI) leads and interviews with parents. We conducted framework analysis.Findings:Resulting themes included: willingness to try anything, Babybe supporting mothers, scepticism and searching for causality, limitations of the Babybe, and beyond the intervention.Conclusions:The Babybe provides socioemotional benefits to mothers of neonatal babies, even though health benefits to their baby are uncertain.
Uthaya S, Jeffries S, Andrewsjewska I, et al., 2022, Randomised controlled trial of human derived breast milk fortifier versus bovine milk fortifier on body composition in very preterm babies, EARLY HUMAN DEVELOPMENT, Vol: 171, ISSN: 0378-3782
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Moss R, Lammons W, Johnson S, et al., 2022, More than words: Parent, Patient and Public Involvement perspectives on language used by clinical researchers in neonatal care, Early Human Development, Vol: 171, Pages: 1-3, ISSN: 0378-3782
In this qualitative study exploring parent views of information about research studies, we found they accepted uncertainty as justification, and that three key aspects of language - words, tone, and pace - influence parents' decision about their baby's inclusion. We recommend parents are routinely involved in developing information materials.
Shah PS, Norman M, Rusconi F, et al., 2022, Five-minute Apgar score and outcomes in neonates of 24-28 weeks' gestation., Arch Dis Child Fetal Neonatal Ed, Vol: 107, Pages: 437-446
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 240 to 286 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.
Webbe J, Uthaya S, Modi N, 2022, Nutrition for the micro preemie: Beyond milk, SEMINARS IN FETAL & NEONATAL MEDICINE, Vol: 27, ISSN: 1744-165X
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- Citations: 1
Abbas-Hanif A, Modi N, Majeed A, 2022, Long term implications of covid-19 in pregnancy, BMJ: British Medical Journal, Vol: 377, ISSN: 0959-535X
Modi N, 2022, Quality of Growth, Body Composition and Longer-Term Metabolic Outcomes
The optimum growth and body composition of the preterm baby is unknown despite non-evidence-based opinions that this should mimic that of the full-term infant. The relationship between body composition at birth, in both preterm and full-term babies, and later cardiometabolic outcomes is also unknown. Newborn body composition is influenced by maternal adiposity and diabetes, gestational age at birth, infant sex, and intrauterine growth restriction. Nutritional intake, breast and formula feeding, illness severity, and possibly growth velocity, are subsequent influences. It is not known whether differences in newborn body composition between ethnic groups are a consequence of genetic endowment, or intrauterine influences. Progress in this area requires funders and investigators to collaborate to establish high-quality, longitudinal cohort studies designed to have the ability to elicit causal inferences, and randomized controlled trials aiming to influence body composition that are of sufficient size to identify effects on functional outcomes at multiple time points across the life course, be generalizable across populations, and have power to detect important interactions.
Modi N, 2022, Rising costs spell disaster for the nation's health, BMJ-BRITISH MEDICAL JOURNAL, Vol: 377, ISSN: 0959-535X
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- Citations: 5
Ramanan A, Modi N, de Wildt SN, 2022, Improving clinical paediatric research and learning from COVID-19: recommendations by the Conect4Children expert advice group, PEDIATRIC RESEARCH, Vol: 91, Pages: 1069-1077, ISSN: 0031-3998
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- Citations: 4
Greenbury SF, Angelini DE, Ougham K, et al., 2022, Post-natal growth of very preterm neonates, The Lancet Child & Adolescent Health, Vol: 6, Pages: E11-E11, ISSN: 2352-4642
Modi N, Conti G, Hanson M, 2022, Post-COVID economic recovery: women and children first ... or last?, ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 107, Pages: 214-215, ISSN: 0003-9888
Webbe J, Longford N, Battersby C, et al., 2022, Outcomes in relation to early parenteral nutrition use in preterm neonates born between 30 and 33 weeks gestation: a propensity score matched observational study, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, Pages: 131-136, ISSN: 1359-2998
ObjectiveTo evaluate whether in preterm neonates parenteral nutrition use in the first sevenpostnatal days, compared with no parenteral nutrition use, is associated withdifferences in survival and other important morbidities. Randomised trials in criticallyill older children show that harms, such as nosocomial infection, outweigh benefits ofearly parenteral nutrition administration; there is a paucity of similar data inneonates.DesignRetrospective cohort study using propensity matching including 35 maternal, infantand organisational factors to minimise bias and confounding.SettingNational, population-level clinical data obtained for all National Health Serviceneonatal units in England and Wales.PatientsPreterm neonates born between 30+0 and 32+6 weeks+days.InterventionsThe exposure was parenteral nutrition administered in the first seven days ofpostnatal life; the comparator was no parenteral nutrition.Main outcome measuresThe primary outcome was survival to discharge from neonatal care. Secondaryoutcomes comprised the neonatal core outcome set.Results16,292 neonates were compared in propensity score matched analyses. Comparedwith 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 ofnecrotising enterocolitis (absolute rate increase 4.6%), bronchopulmonary dysplasia(absolute rate increase 3.9%), late-onset sepsis (absolute rate increase 1.5%) andneed for surgical procedures (absolute rate increase 0.92%).ConclusionsIn neonates born between 30+0 and 32+6 weeks gestation, those given parenteralnutrition in the first postnatal week had a higher rate of survival but higher rates ofimportant neonatal morbidities. Clinician equipoise in this area should be resolvedby prospective, randomised trials.
Uthaya S, Longford N, Battersby C, et al., 2022, Early versus later initiation of parenteral nutrition for very preterm infants: a propensity score matched observational study, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 107, ISSN: 1359-2998
Background: A current standard of care based on expert opinion is to commence parenteral nutrition (PN) within hours of birth in very preterm infants. Trials in critically ill adults and children, including term infants have found short and long-term harms from early initiation of PN. Methods: We included all infants born below 31 weeks gestation between January 2008 and December 2019 and admitted to National Health Service neonatal units in England and Wales. The source of data was the National Neonatal Research Database. The exposure was PN initiated within the first two days after birth (early) versus after the second postnatal day (late). We used propensity matched analysis to balance the two groups on background variables. The primary outcome was survival to discharge without major morbidity. Findings: Of 65,033 infants included, 16,294 infants formed the matched cohort, 8147 in each group. There was no evidence of a difference in survival to discharge without major morbidity (absolute rate difference (ARD) between early versus late 0·50%; 95% Confidence Interval (CI), -1·45, 0·45; p=0·29). Survival to discharge was higher in the early group (ARD -3·25%; 95% CI, -3·82 to -2·68; p<0·001) but they also had higher rates of late-onset sepsis (ARD -0·84%; 95% CI, -1·20 to -0·48; p<0·001), bronchopulmonary dysplasia (ARD -1·24%; 95% CI, -2·17 to -0·30; p=0·01), treatment for retinopathy of prematurity (ARD (-0·5%; 95% CI, -0·84 to -0.17; p<0·001), surgical procedures (ARD -0·8%; 95% CI, -1·40 to -0·20; p=0·01) and greater drop in weight z-score between birth and discharge (absolute difference 0·019; 95% CI, 0·003 to 0·039; p=0·02). Among infants that died the median age (days) at death was shorter in the late group (ARD 6; 95% CI, 6; p<0.001). Interpretation: These o
Modi N, 2022, [Investigaciones futuras sobre nutrición de prematuros]., World Rev Nutr Diet, Vol: 122, Pages: 384-394
Abbas-Hanif A, Modi N, Smith SK, et al., 2021, Covid-19 treatments and vaccines must be evaluated in pregnancy., BMJ-British Medical Journal, Vol: 375, ISSN: 1756-1833
Greenbury SF, Longford N, Ougham K, et al., 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, Vol: 11, ISSN: 2044-6055
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 substantia
Greenbury SF, Angelini ED, Ougham K, et al., 2021, Birthweight and patterns of postnatal weight gain in very and extremely preterm babies in England and Wales, 2008-19: a cohort study, The Lancet Child & Adolescent Health, Vol: 5, Pages: 719-728, ISSN: 2352-4642
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 post
Hage L, Jeyakumaran D, Dorling J, et al., 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, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 106, Pages: 501-508, ISSN: 1359-2998
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.
Greenbury SF, Angelini ED, Ougham K, et al., 2021, Birthweight and Patterns of Postnatal Weight Gain in Very and Extremely Preterm Babies: A 12 Year, Whole Population Study, The Lancet Child & Adolescent Health, ISSN: 2352-4642
Lammons W, Moss R, Battersby C, et al., 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 Paediatrics Open, Vol: 5, ISSN: 2399-9772
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.
Seaton SE, Draper ES, Adams M, et al., 2021, Variations in Neonatal Length of Stay of Babies Born Extremely Preterm: An International Comparison Between iNeo Networks, JOURNAL OF PEDIATRICS, Vol: 233, Pages: 26-+, ISSN: 0022-3476
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Modi N, 2021, The implications of routine milk fortification for the short and long-term health of preterm babies, SEMINARS IN FETAL & NEONATAL MEDICINE, Vol: 26, ISSN: 1744-165X
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- Citations: 3
Modi N, Ayres-de-Campos D, Bancalari E, et al., 2021, Equity in coronavirus disease 2019 vaccine development and deployment, AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY, Vol: 224, Pages: 423-427, ISSN: 0002-9378
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- Citations: 25
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