Imperial College London

ProfessorNeenaModi

Faculty of MedicineSchool of Public Health

Professor of Neonatal Medicine
 
 
 
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Contact

 

+44 (0)20 3315 5102n.modi

 
 
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Assistant

 

Ms Surbhi Shah +44 (0)20 3315 5101

 
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Location

 

G4.2 ()Chelsea and Westminster HospitalChelsea and Westminster Campus

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Summary

 

Publications

Publication Type
Year
to

293 results found

Gagliardi L, Rusconi F, Reichman B, Adams M, Modi N, Lehtonen L, Kusuda S, Vento M, Darlow BA, Bassler D, Isayama T, Norman M, Håkansson S, Lee SK, Lui K, Yang J, Shah P, International Network for Evaluating Outcomes of Neonates iNeo Investigatorset al., 2021, Neonatal outcomes of extremely preterm twins by sex pairing: an international cohort study., Arch Dis Child Fetal Neonatal Ed, Vol: 106, Pages: 17-24

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.

Journal article

Battersby C, Gale C, Modi N, 2020, CLINICAL TRIALS IN NEC RESEARCH: Advances, Perils, and Pitfalls, Necrotizing Enterocolitis: Insights into Pathogenesis, Diagnosis and Treatment, Editors: Hackham, Publisher: World Scientific, ISBN: 978-981-4725-94-1

Book chapter

Modi N, Hanson M, 2020, Maternal, neonatal, and child health is essential for meeting SDG 3.4., Lancet, Vol: 396, Pages: 1731-1732

Journal article

Jacob CM, Briana DD, Di Renzo GC, Modi N, Bustreo F, Conti G, Malamitsi-Puchner A, Hanson Met al., 2020, Building resilient societies after COVID-19: the case for investing in maternal, neonatal, and child health, LANCET PUBLIC HEALTH, Vol: 5, Pages: E624-E627, ISSN: 2468-2667

Journal article

Modi N, 2020, Preterm Nutrition in 2020: Breast Milk, Probiotics and Other Components, Publisher: KARGER, Pages: 404-405, ISSN: 1661-7800

Conference paper

Yeo KT, Oei JL, De Luca D, Schmölzer GM, Guaran R, Palasanthiran P, Kumar K, Buonocore G, Cheong J, Owen LS, Kusuda S, James J, Lim G, Sharma A, Uthaya S, Gale C, Whittaker E, Battersby C, Modi N, Norman M, Naver L, Giannoni E, Diambomba Y, Shah PS, Gagliardi L, Harrison M, Pillay S, Alburaey A, Yuan Y, Zhang Het al., 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 Paediatrica: Nurturing the Child, Vol: 109, Pages: 2192-2207, ISSN: 1651-2227

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 25 May 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 USA. 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 were 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.

Journal article

Prior E, Modi N, 2020, Adult outcomes after preterm birth., Postgrad Med J, Vol: 96, Pages: 619-622

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.

Journal article

Haumont D, Modi N, Saugstad OD, Antetere R, Cuong N, Turner M, Costeloe K, Aelvoet Wet al., 2020, Evaluating preterm care across Europe using the eNewborn European Network database, Pediatric Research, Vol: 88, Pages: 484-495, ISSN: 0031-3998

BackgroundThe inefficiency of recording data repeatedly limits the number of studies conducted. Here we illustrate the wider use of data captured as part of the European eNewborn benchmarking programme.MethodsWe extracted data on 39,529 live-births from 22 weeks 0 days to 31 weeks 6 days gestational age (GA) or ≤1500 g birth weight. We explored relationships between delivery room care and Apgar scores on mortality and bronchopulmonary dysplasia (BPD) and calculated the time needed for each country to detect a clinically relevant change in these outcomes following a hypothetical intervention.ResultsEarly neonatal, neonatal, and in-hospital mortality were 3.90% (95% CI 3.71, 4.09), 6.00% (5.77, 6.24) and 7.57% (7.31, 7.83), respectively. The odds of death were greater with decreasing GA, lower Apgar scores, growth restriction, male sex, multiple birth and no antenatal steroids. Relationships for BPD were similar. The time required for participating countries to achieve 80% power to detect a relevant change in outcomes following a hypothetical intervention in 23–25 weeks’ GA infants ranged from 12 years for neonatal mortality and 22 years for BPD compared to 1 year for the whole network.ConclusionsThe eNewborn platform offers opportunity to drive efficiencies in benchmarking, quality control and research.

Journal article

Wong HS, Wadon M, Evans A, Kirov G, Modi N, O'Donovan MC, Thapar Aet al., 2020, Contribution of de novo and inherited rare CNVs to very preterm birth, JOURNAL OF MEDICAL GENETICS, Vol: 57, Pages: 552-557, ISSN: 0022-2593

Journal article

Wong HS, Hopkins L, ODonovan MC, Thapar A, Modi Net al., 2020, Pilot study to establish a prospective neonatal cohort: Study of Preterm Infants and Neurodevelopmental Genes (SPRING), BMJ Paediatrics Open, Vol: 4, ISSN: 2399-9772

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 one-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 (inter-quartile range) gestation 28.9 (26-30) weeks; birthweight 1120 (886-1420) grams) 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.

Journal article

Webbe J, Duffy JMN, Afonso E, Al-Muzaffar I, Brunton G, Greenough A, Hall NJ, Knight M, Latour JM, Lee-Davey C, Marlow N, Noakes L, Nycyk J, Richard-Löndt A, Wills-Eve B, Modi N, Gale Cet al., 2020, Core outcomes in neonatology: Development of a core outcome set for neonatal research, Archives of Disease in Childhood: Fetal and Neonatal Edition, Vol: 105, Pages: 425-431, ISSN: 1359-2998

BackgroundNeonatal research evaluates many different outcomes using multiple measures. This canprevent synthesis of trial results in meta-analyses and selected outcomes may not berelevant to former patients, parents and health professionals.ObjectiveTo define a core outcome set (COS) for research involving infants receiving neonatal care ina high income setting.DesignOutcomes reported in neonatal trials and qualitative studies were systematically reviewed.Stakeholders were recruited for a three-round international Delphi survey. A consensusmeeting was held to confirm the final COS, based upon the survey results.ParticipantsFour hundred and fourteen former patients, parents, healthcare professionals andresearchers took part in the eDelphi survey; 173 completed all 3 rounds. Sixteenstakeholders participated in the consensus meeting.ResultsThe literature reviews identified 104 outcomes; these were included in round one.Participants proposed ten additional outcomes; 114 outcomes were scored in round two andthree. Round one scores showed different stakeholder groups prioritised contrastingoutcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotisingenterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability,quality of life, adverse events, visual impairment/blindness, hearing impairment /deafness,retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.6Conclusions and relevanceA COS for clinical trials and other research studies involving infants receiving neonatal carein a high-income setting has been identified. This COS for neonatology will help standardiseoutcome selection in clinical trials and ensure these are relevant to those most affected byneonatal care.

Journal article

Modi N, 2020, Children first, or last?, EBIOMEDICINE, Vol: 56, ISSN: 2352-3964

Journal article

Sakonidou S, Andrzejewska I, Webbe J, Modi N, Bell D, Gale Cet al., 2020, Interventions to improve quantitative measures of parent satisfaction in neonatal care: a systematic review, BMJ Paediatrics Open, Vol: 4, ISSN: 2399-9772

Objective: Interventions improving parent satisfaction can reduce parent stress, may improve parent-infant bonding and infant outcomes. Our objective was to systematically review neonatal interventions relating to parents of infants of all gestations where an outcome was parent satisfaction. Methods: We searched the databases MEDLINE, EMBASE, PsychINFO, Cochrane Central Register of Controlled Trials, CINAHL, HMIC, Maternity and Infant Care between 1 January 1946 and 1 October 2017. Inclusion criteria were randomised controlled trials (RCT), cohort studies and other non-randomised studies if participants were parents of infants receiving neonatal care, interventions were implemented in neonatal units (of any care level) and ≥1 quantitative outcome of parent satisfaction was measured. Included studies were limited to the English language only. We extracted study characteristics, interventions, outcomes and parent involvement in intervention design. Included studies were not sufficiently homogenous to enable quantitative synthesis. We assessed quality with the Cochrane Collaboration risk of bias tool (randomised) and the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) (non-randomised studies). Results: We identified 32 studies with satisfaction measures from over 2800 parents and grouped interventions into 5 themes. Most studies were non-randomised involving preterm infants. Parent satisfaction was measured by 334 different questions in 29 questionnaires (only 6/29 fully validated). 18/32 studies reported higher parent satisfaction in the intervention group. The intervention theme with most studies reporting higher satisfaction was parent involvement (10/14). Five (5/32) studies reported involving parents in intervention design. All studies had high risk of bias. Conclusions: Many interventions, commonly relating to parent involvement, are reported to improve parent satisfaction. Inconsistency in satisfaction measurements and high risk of b

Journal article

Helenius K, Longford N, Lehtonen L, Modi N, Gale Cet al., 2020, Association of early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury in extremely preterm infants: observational cohort study with propensity score matching, Obstetrical and Gynecological Survey, Vol: 75, Pages: 145-147, ISSN: 0029-7828

Approximately 1 in 20 preterm infants in high-income countries are born at less than 28 weeks' gestation with increased risk of death and morbidity. Previous studies have shown improved outcomes when care is provided in tertiary hospitals as compared with nontertiary hospitals; this study aims to examine the rate of adverse outcomes for those preterm infants who underwent postnatal transfer to a tertiary facility in England.

Journal article

Modi N, 2020, Votes for a better future, ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 105, Pages: 13-14, ISSN: 0003-9888

Journal article

Goss KCW, Gale C, Malone R, Longford N, Ratcliffe K, Modi Net al., 2020, Effect of surfactant dose on outcomes in preterm infants with respiratory distress syndrome: the OPTI-SURF study protocol, BMJ OPEN, Vol: 10, ISSN: 2044-6055

Journal article

Modi N, 2020, Improving the Efficiency and Impact of Clinical Research: A Game Changer for 21st Century Neonatology., Neonatology, Vol: 117, Pages: 207-210

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.

Journal article

Wadon M, Modi N, Wong HS, Thapar A, O'Donovan MCet al., 2019, Recent advances in the genetics of preterm birth, ANNALS OF HUMAN GENETICS, Vol: 84, Pages: 205-213, ISSN: 0003-4800

Journal article

Webbe J, Ali S, Sakonidou S, Webbe T, Duffy J, Brunton G, Modi N, Gale Cet al., 2019, Inconsistent outcome reporting in large neonatal trials: a systematic review, Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 105, Pages: 69-75, ISSN: 1359-2998

ObjectiveInconsistent outcome selection and reporting in clinical trials are important sources of research waste; it is not known how common this problem is in neonatal trials. Our objective was to determine whether large clinical trials involving infants receiving neonatal care report a consistent set of outcomes, how composite outcomes are used and whether parents or former patients were involved in outcome selection.DesignA literature search of CENTRAL, CINAHL, EMBASE and Medline was conducted; randomised trials published between July 1st 2012 and July 1st 2017 and involving at least 100 infants in each arm were included. Outcomes and outcome measures were extracted and categorised by physiological system; reported former patient and parent involvement in outcome selection was extracted.ResultsSeventy six trials involving 43126 infants were identified; 216 different outcomes with 889 different outcome measures were reported. Outcome reporting covered all physiological systems but was variable between individual trials: only 67/76 (88%) of trials reported survival and 639 outcome measures were only reported in a single trial. Thirty three composite outcomes were used in 41 trials. No trials reported former patient or parent involvement in outcome selection.ConclusionsInconsistent outcome reporting and a lack of parent and former patient involvement in outcome selection in neonatal clinical trials limits the ability of such trials to answer clinically meaningful questions. Developing and implementing a core outcome set for future neonatal trials, with input from all stakeholders, should address these issues.

Journal article

Jawad S, Modi N, Prevost AT, Gale Cet al., 2019, A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data, Trials, Vol: 20, ISSN: 1745-6215

BackgroundWe aimed to test whether a common set of key data items reported across high impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD). MethodsWe systematically reviewed neonatal clinical trials published in four high impact medical journals over 10 years (2006-2015) and extracted baseline characteristics, stratification items, and potential confounders used to adjust primary outcomes. Completeness was examined using data held in the NNRD for identified data items, for infants admitted to neonatal units in 2015. The NNRD is a repository of routinely recorded data extracted from neonatal Electronic Patient Records (EPR) of all admissions to National Health Service (NHS) Neonatal Units in England, Wales and Scotland. We defined missing data as an empty field or an implausible value. We reported common data items as frequencies and percentages alongside percentages of completeness. ResultsWe identified 44 studies involving 32,095 infants and 126 data items. Fourteen data items were reported by more than 20% of studies (table 2). Gestational age (95%), sex (93%) and birth weight (91%) were the most common baseline data items. The completeness of data in the NNRD was high for these data with greater than 90% completeness found for 9 of the 14 most common items.Conclusion High impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined.

Journal article

Parkinson JRC, Emsley R, Adkins JLT, Longford N, Ozanne SE, Holmes E, Modi Net al., 2019, Clinical and molecular evidence of accelerated ageing following very preterm birth, Pediatric Research, Vol: 87, Pages: 1005-1010, ISSN: 0031-3998

BACKGROUND: The mechanisms responsible for the associations between very preterm birth and a higher risk of poor cardiovascular and metabolic health in adult life are unknown. METHODS: Here, we compare the clinical and molecular phenotypes of healthy, normal-weight young adults (18-27 years), born very preterm (<33 weeks gestational age (GA)) and at full-term (37-42 weeks GA). Outcomes included whole-body MRI, hepatic and muscle 1H MRS, blood pressure measurements and telomere length. RESULTS: We recruited 156 volunteers, 69 preterm (45 women; 24 men) and 87 born at full-term (45 women; 42 men). Preterm individuals had a significantly altered blood pressure profile, including higher systolic blood pressure (SBP mmHg: preterm men 133.4 ± 10.1, term men 23.0 ± 6.9; preterm women 124.3 ± 7.1, term women 118.4 ± 8.0, p < 0.01 for all). Furthermore, preterm men had fewer long telomeres (145-48.5 kb: preterm men 14.1 ± 0.9%, term men 17.8 ± 1.1%, p < 0.05; 48.5-8.6 kb: preterm men 28.2 ± 2.6, term men 37.0 ± 2.4%, p < 0.001) and a higher proportion of shorter telomeres (4.2-1.3 kb: preterm men 40.4 ± 3.5%, term men 29.9 ± 3.2%, p < 0.01). CONCLUSION: Our data indicate that healthy young adults born very preterm manifest clinical and molecular evidence of accelerated ageing.

Journal article

Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K, Allen M, Allen A, Freimane DA, Aschner J, Ballard R, Belew Y, Bax R, Bellflower B, Bhatt-Mehta V, Blum M, Bonardi C, Bondurant P, Boylan G, Buracchio T, Burckart G, Burnett A, Burnham J, Carlson C, Chen A, Clay B, Cohen A, Connolly E, Connor E, Darsey E, De Lisa R, Degl J, Dempsey E, Diacovo T, Dionne J, Duchon J, Eklund W, Fabbri L, Fielder A, Freilich E, Furst-Recktenwald S, Graham T, Green D, Grogan C, Heiselman D, Hellstrom A, Herold R, Hibbs AM, Hirschfeld S, Brown MH, Holberton J, Iveli P, Jobe A, Kayton A, Kenner C, Kraft W, Kusuda S, Lacaze T, Lewis T, Lui K, Lutsar I, Mangili A, Mangum B, McCune S, McDonald K, McGuire C, McPherson C, Miller T, Ming J, Mitzner A, Modi N, Morrison M, Morsing E, Mulugeta L, Nakamura H, Nelson S, Noel G, Olshansky M, Oschman A, Ozsahin H, Padula M, Peiris V, Koplowitz LP, Pham J, Pilon A, Portman R, Pressler R, Rabe H, Raju T, Roepke DA, Savani R, Schnell P, Segal R, Senterre T, Shah P, Sheridan P, Sherwin C, Singh R, Soll R, Soul J, Spence K, Storari L, Taminiau J, Tseng B, Van Den Anker J, Varga J, Venkataraman P, Vivas N, Walker K, Wilson J, Zajicek A, Zaloga G, Zeldis Set al., 2019, Development of a neonatal adverse event severity scale through a Delphi consensus approach, ARCHIVES OF DISEASE IN CHILDHOOD, Vol: 104, Pages: 1167-+, ISSN: 0003-9888

Journal article

Lui K, Lee SK, Kusuda S, Adams M, Vento M, Reichman B, Darlow BA, Lehtonen L, Modi N, Norman M, Hakansson S, Bassler D, Rusconi F, Lodha A, Yang J, Shah PS, Marshall P, Schmidt P, Dhawan A, Craven P, de Waal K, Simmer K, Gill A, Pillow J, Stack J, Birch P, Cooke L, Casalaz D, Holberton J, Stewart A, Downe L, Stewart M, Bajuk B, Berry A, Hunt R, Kilburn C, De Paoli T, Bolisetty S, Paradisis M, Rieger I, Koorts P, Kuschel C, Doyle L, Numa A, Carlisle H, Badawi N, Loughran-Fowlds A, Koh G, Davis J, Luig M, Andersen C, Chambers G, Austin N, Lynn A, Darlow B, Edmonds L, Mildenhall L, Buksh M, Battin M, van den Boom J, Bourchier D, Richardson V, Dineen F, Rajadurai VS, Lam S, Fung G, Harrison A, Synnes A, Cieslak Z, Sherlock R, Yee W, Aziz K, Fajardo C, Kalapesi Z, Sankaran K, Daspal S, Seshia M, Alvaro R, Mukerji A, Da Silva O, Nwaesei C, Lee K-S, Dunn M, Lemyre B, Dow K, Pelausa E, Barrington K, Drolet C, Piedboeuf B, Claveau M, Beltempo M, Bertelle V, Masse E, Canning R, Makary H, Ojah C, Monterrosa L, Deshpandey A, Afifi J, Kajetanowicz A, Andersson S, Tammela O, Sankilampi U, Saarela T, Prazad P, Noguchi A, McWan K, Button B, Stratton W, Hamvus A, Raghaven A, Derrick M, Hadley R, Covert R, Lablanc O, Weiss M, Bell A, Shareef M, Silvestri J, Heymann E, Zangen S, Smolkin T, Mimouni F, Bader D, Rothschild A, Strauss Z, Felszer C, Omari H, Tov-Friedman SE, Bar-Oz B, Feldman M, Saad N, Flidel-Rimon O, Weisbrod M, Lubin D, Litmanovitz I, Kugelman A, Shinwell E, Klinger G, Nijim Y, Bin-Nun A, Golan A, Mandel D, Fleisher-Sheffer V, Kohelet D, Bakhrakh L, Hattori S, Shirai M, Ishioka T, Mori T, Amizuka T, Huchimukai T, Yoshida H, Sasaki A, Shimizu J, Nakamura T, Maruyama M, Matsumoto H, Hosokawa S, Taki A, Nakagawa M, Ko K, Uozumi A, Nakata S, Shimazaki A, Yoda T, Numata O, Imamura H, Kobayashi A, Tokuriki S, Uchida Y, Arai T, Ito M, Ieda K, Ono T, Hayashi M, Maki K, Yamakawa M, Kawai M, Fujii N, Shiomi K, Nozaki K, Wada H, Kim T, Tokunaga Y, Takatera A, Oshima T, Sumida H Met al., 2019, Trends in Outcomes for Neonates Born Very Preterm and Very Low Birth Weight in 11 High-Income Countries, JOURNAL OF PEDIATRICS, Vol: 215, Pages: 32-+, ISSN: 0022-3476

Journal article

Shahroor M, Lehtonen L, Lee SK, Hakansson S, Vento M, Darlow BA, Adams M, Mori A, Lui K, Bassler D, Morisaki N, Modi N, Noguchi A, Kusuda S, Beltempo M, Helenius K, Isayama T, Reichman B, Shah PSet al., 2019, Unit-Level Variations in Healthcare Professionals' Availability for Preterm Neonates < 29 Weeks' Gestation: An International Survey, NEONATOLOGY, Vol: 116, Pages: 347-355, ISSN: 1661-7800

Journal article

Helenius K, Longford N, Lehtonen L, Modi N, Gale C, Babirecki M, Kamalanathan A, Wickham T, Aucharaz K, Gupta A, Paul N, Wong LM, Mittal A, Broggio P, Surana P, Singh A, Seal S, Hassan A, Schwarz K, Thomas M, Foo A, Anderson J, Whincup G, Brearey S, Chang J, Gad K, Hasib A, Garbash M, Allwood A, Adiotomre P, Brooke N, Deketelaere A, Khader KA, Shephard R, Rekha S, Abuzgia B, Jain M, Pirie S, Surana P, Zengeya S, Watts T, Balal S, Seagrave C, Bate T, Dixon H, Aladangady N, Gaili H, James M, Lal M, Ambadkar P, Pandey P, Hickey A, Rhodes S, Pai V, Lama M, Miall L, Cusack J, Kairamkonda V, Grosdenier M, Kollipara L, Kefas J, Yoxall B, Birch J, Whitehead G, Krishnamurthy R, Sashikumar P, Misra I, Pillay T, Ali I, Thiagarajan P, Dyke M, Selter M, Kamath P, Alsford L, Spencer V, Gupta S, Nicholl R, Wardle S, Chakrabarti S, Adams E, McDevitt K, Reddy A, Gibson D, Khashu M, Reddy C, Pearson F, Amess P, Deshpande S, Sleight E, Groves C, Godambe S, Bosman D, Rewitzky G, Banjoko O, Kumar N, Muogbo D, Lopez W, D'Amore A, Mattara S, Zipitis C, De Halpert P, Settle P, Munyard P, McIntyre J, Bartle D, Pain K, Fedee J, Maddock N, Gupta R, Moore A, Godden C, Amess P, Jones S, Fenton A, Mahadevan S, Brown N, Mack K, Adiotomre P, Bolton R, Khan A, Mannix P, Huddy C, Yasin S, Butterworth S, Godambe S, Nedungadi S, Cairns P, Reynolds P, Brennan N, Heal C, Salgia S, Abu-Harb M, Birch J, Knight C, Clark S, Theron M, Murthy V, Paul S, Kisat H, Kendall G, Blake K, Obi O, Garbash M, Kumar H, Rawlingson C, Webb D, Bird S, Narayanan S, Eyre E, Evans I, Sanghavi R, Sullivan C, Garr R, Leith W, Vasu V, Harry L, Vamvakiti K, Vemuri G, Eaton M, Samy Met al., 2019, Association of early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury in extremely preterm infants: observational cohort study with propensity score matching, BMJ: British Medical Journal, Vol: 367, Pages: 1-11, ISSN: 0959-535X

Objective To determine if postnatal transfer or birth in a non-tertiary hospital is associated with adverse outcomes.Design Observational cohort study with propensity score matching.Setting National health service neonatal care in England; population data held in the National Neonatal Research Database.Participants Extremely preterm infants born at less than 28 gestational weeks between 2008 and 2015 (n=17 577) grouped based on birth hospital and transfer within 48 hours of birth: upward transfer (non-tertiary to tertiary hospital, n=2158), non-tertiary care (born in non-tertiary hospital; not transferred, n=2668), and controls (born in tertiary hospital; not transferred, n=10 866). Infants were matched on propensity scores and predefined background variables to form subgroups with near identical distributions of confounders. Infants transferred between tertiary hospitals (horizontal transfer) were separately matched to controls in a 1:5 ratio.Main outcome measures Death, severe brain injury, and survival without severe brain injury.Results 2181 infants, 727 from each group (upward transfer, non-tertiary care, and control) were well matched. Compared with controls, infants in the upward transfer group had no significant difference in the odds of death before discharge (odds ratio 1.22, 95% confidence interval 0.92 to 1.61) but significantly higher odds of severe brain injury (2.32, 1.78 to 3.06; number needed to treat (NNT) 8) and significantly lower odds of survival without severe brain injury (0.60, 0.47 to 0.76; NNT 9). Compared with controls, infants in the non-tertiary care group had significantly higher odds of death (1.34, 1.02 to 1.77; NNT 20) but no significant difference in the odds of severe brain injury (0.95, 0.70 to 1.30) or survival without severe brain injury (0.82, 0.64 to 1.05). Compared with infants in the upward transfer group, infants in the non-tertiary care group had no significant difference in death before discharge (1.10, 0.84

Journal article

Gale C, Modi N, Jawad S, Culshaw L, Dorling J, Bowler U, Forster A, King A, McLeish J, Linsell L, Turner MA, Robberts H, Stanbury K, van Staa T, Juszczak Eet al., 2019, The WHEAT pilot trial-WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multicentre, electronic patient record (EPR), randomised controlled point-of-care pilot trial., BMJ Open, Vol: 9, Pages: 1-7, ISSN: 2044-6055

INTRODUCTION: Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment. METHODS AND ANALYSIS: We will undertake a randomised, controlled, multicentre, unblinded, pilot trial comparing two care pathways: continuing milk feeds (before, during and after red cell transfusions) and withholding milk feeds (for 4 hours before, during and for 4 hours after red cell transfusions), with infants randomly assigned with equal probability. We will use opt-out consent. A nested qualitative study will explore parent and health professional views. Infants will be eligible if born at <30+0 gestational weeks+days. Primary feasibility outcomes will be rate of recruitment, opt-out, retention, compliance, data completeness and data accuracy; clinical outcomes will include mortality and NEC. The trial will recruit in two neonatal networks in England for 9 months. Data collection will continue until all infants have reached 40+0 corrected gestational weeks or neonatal discharge. Participant identification and recruitment, randomisation and all trial data collection will be embedded within existing neonatal EPR systems (BadgerNet and BadgerEPR); outcome data will be extracted from routinely recorded data held in the National Neonatal Research Database. ETHICS AND DISSEMINATION: This study holds Research Ethics Committee approval to use an opt-out approach to consent. Results will infor

Journal article

Gale C, Modi N, Jawad S, Culshaw L, Dorling J, Bowler U, Forster A, King A, McLeish J, Linsell L, Turner M, Robberts H, Stanbury K, van Staa T, Juszczak Eet al., 2019, Study Protocol: The WHEAT pilot trial - WithHolding Enteral feeds Around packed red cell Transfusion to prevent necrotising enterocolitis in preterm neonates: a multi-centre, electronic patient record (EPR), randomised controlled point-of-care pilot trial, BMJ Open, ISSN: 2044-6055

Necrotising enterocolitis (NEC) is a potentially devastating neonatal disease. A temporal association between red-cell transfusion and NEC is well described. Observational data suggest that withholding enteral feeds around red-cell transfusions may reduce the risk of NEC but this has not been tested in randomised trials; current UK practice varies. Prevention of NEC is a research priority but no appropriately powered trials have addressed this question. The use of a simplified opt-out consent model and embedding trial processes within existing electronic patient record (EPR) systems provide opportunities to increase trial efficiency and recruitment.

Journal article

Mills L, Coulter L, Savage E, Modi Net al., 2019, Macronutrient content of donor milk from a regional human milk bank: variation with donor mother-infant characteristics., The British Journal of Nutrition: an international journal of nutritional science, Vol: 122, Pages: 1155-1167, ISSN: 0007-1145

Better understanding of the variation in macronutrient content of human donor milk (HDM) potentiates targeted nutrition for preterm babies. This study describes the relationship of maternal age, parity, monthly lactation stage estimate (LSEm), daily volume of milk expressed (Vd), sex, gestation, and birthweight z scores, with macronutrient content of HDM. Multilevel mother-infant pair ID random intercept models were performed using the predictor variables above on the outcome HDM macronutrient content determined using mid infrared spectroscopy. Mean macronutrient content was also compared by gestational age, and small or appropriate for gestational age (SGA) (z score <-1.28) or (AGA) (z score ≥ -1.28) categories. 2966 samples of donations from 1175 mother-infant pairs to the UK North West Human Milk Bank between 2011-2017 were analysed. Mean (sd) protein, fat, carbohydrate, and calculated energy, were 0.89 (0.24) g/dl, 2.99 (0.96) g/dl, 7.09 (0.44) g/dl, and 60.37 (8.41) kcal/dl respectively. Preterm SGA HDM was significantly higher in protein, fat, and energy content than term AGA HDM, and significantly lower in carbohydrate content than term AGA HDM after controlling for LSEm, Vd, and between subject effects. Degree of prematurity did not influence macronutrient content. Between subject effects accounted for more of the variance in macronutrient content than the fixed effects in the model. Despite this, SGA status, as well as prematurity, may be an important determinant of macronutrient content in human milk. As bioavailability of macronutrients from HDM is uncertain, studies evaluating growth and body composition in preterm and SGA babies fed HDM are warranted.

Journal article

Modi N, Ashby D, Battersby C, Brocklehurst P, Chivers Z, Costeloe K, Draper ES, Foster V, Kemp J, Majeed A, Murray J, Petrou S, Rogers K, Santhakumaran S, Saxena S, Statnikov Y, Wong H, Young Aet al., 2019, Developing routinely recorded clinical data from electronic patient records as a national resource to improve neonatal health care: the Medicines for Neonates research programme, Programme Grants for Applied Research, Vol: 7, Pages: 1-396, ISSN: 2050-4322

BackgroundClinical data offer the potential to advance patient care. Neonatal specialised care is a high-cost NHS service received by approximately 80,000 newborn infants each year.Objectives(1) To develop the use of routinely recorded operational clinical data from electronic patient records (EPRs), secure national coverage, evaluate and improve the quality of clinical data, and develop their use as a national resource to improve neonatal health care and outcomes. To test the hypotheses that (2) clinical and research data are of comparable quality, (3) routine NHS clinical assessment at the age of 2 years reliably identifies children with neurodevelopmental impairment and (4) trial-based economic evaluations of neonatal interventions can be reliably conducted using clinical data. (5) To test methods to link NHS data sets and (6) to evaluate parent views of personal data in research.DesignSix inter-related workstreams; quarterly extractions of predefined data from neonatal EPRs; and approvals from the National Research Ethics Service, Health Research Authority Confidentiality Advisory Group, Caldicott Guardians and lead neonatal clinicians of participating NHS trusts.SettingNHS neonatal units.ParticipantsNeonatal clinical teams; parents of babies admitted to NHS neonatal units.InterventionsIn workstream 3, we employed the Bayley-III scales to evaluate neurodevelopmental status and the Quantitative Checklist of Autism in Toddlers (Q-CHAT) to evaluate social communication skills. In workstream 6, we recruited parents with previous experience of a child in neonatal care to assist in the design of a questionnaire directed at the parents of infants admitted to neonatal units.Data sourcesData were extracted from the EPR of admissions to NHS neonatal units.Main outcome measuresWe created a National Neonatal Research Database (NNRD) containing a defined extract from real-time, point-of-care, clinician-entered EPRs from all NHS neonatal units in England, Wales and Scotland (

Journal article

Seaton SE, Draper ES, Abrams KR, Modi N, Manktelow BN, Babirecki M, Kamalanathan A, TimWickham, Aucharaz K, Gupta A, Paul N, Wong LM, Mittal A, Broggio P, Surana P, Singh A, Seal S, Hassan A, Schwarz K, Thomas M, Foo A, JoAnderson, Whincup G, Brearey S, Chang J, Gad K, Hasib A, Garbash M, Allwood A, Adiotomre P, NigelBrooke, Deketelaere A, Khader A, Shephard R, SanghaviRekha, Abuzgia B, Jain M, Pirie S, Surana P, Zengeya S, Watts T, Balal S, Seagrave C, TristanBate, Dixon H, Aladangady N, Gaili H, MatthewJames, Lal M, Ambadkar, Pandey P, Hickey A, SimonRhodes, Pai V, Lama M, Miall L, Cusack J, Kairamkonda V, Grosdenier M, Kollipara, Kefas J, Yoxall B, Birch J, Whitehead G, Krishnamurthy, Sashikumar P, Misra I, Pillay T, Ali I, Dyke M, Selter M, Kamath P, Alsford L, Spencer V, Gupta S, Nicholl R, StevenWardle, Chakrabarti S, Adams E, McDevitt K, AjayReddy, Gibson D, Khashu M, Reddy C, FreyaPearson, Amess P, Deshpande, Sleight E, Groves C, Godambe S, Bosman D, Rewitzky G, Banjoko O, NKumar, Muogbo D, Lopez W, D'Amore A, ShameelMattara, Zipitis C, De Halpert P, Settle P, PaulMunyard, McIntyre J, Bartle D, Pain K, Fedee J, Maddock N, Gupta R, Moore A, Godden C, Amess P, Jones S, Fenton A, Mahadevan, Brown N, Mack K, Adiotomre P, Bolton R, Gupta V, Mannix P, Huddy C, Yasin S, Butterworth S, Godambe S, Nedungadi S, Cairns P, Reynolds P, Brennan N, Heal C, Salgia S, Abu-Harb M, Birch J, Knight C, Clark S, Theron M, Murthy V, Paul S, HamudiKisat, Kendall G, Blake K, Obi O, Garbash M, Kumar H, Rawlingson C, Webb D, Bird, Narayanan S, Eyre E, Evans I, Sanghavi R, Sullivan C, Garr R, Leith W, Vasu V, Harry L, Vamvakiti K, Vemuri G, Eaton M, Samy Met al., 2019, Can we estimate the length of stay of very preterm multiples?, ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, Vol: 104, Pages: F568-+, ISSN: 1359-2998

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