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• Journal article
  Pillay T, Modi N, Rivero-Arias O, Manktelow B, Seaton SE, Armstrong N, Draper ES, Dawson K, Paton A, Ismail AQT, Yang M, Boyle EMet al., 2019,

  Optimising neonatal service provision for preterm babies born between 27 and 31 weeks gestation in England (OPTI-PREM), using national data, qualitative research and economic analysis: a study protocol.

  , BMJ Open, Vol: 9, Pages: 1-9, ISSN: 2044-6055

  INTRODUCTION: In England, for babies born at 23-26 weeks gestation, care in a neonatal intensive care unit (NICU) as opposed to a local neonatal unit (LNU) improves survival to discharge. This evidence is shaping neonatal health services. In contrast, there is no evidence to guide location of care for the next most vulnerable group (born at 27-31 weeks gestation) whose care is currently spread between 45 NICU and 84 LNU in England. This group represents 12% of preterm births in England and over onr-third of all neonatal unit care days. Compared with those born at 23-26 weeks gestation, they account for four times more admissions and twice as many National Health Service bed days/year. METHODS: In this mixed-methods study, our primary objective is to assess, for babies born at 27-31 weeks gestation and admitted to a neonatal unit in England, whether care in an NICU vs an LNU impacts on survival and key morbidities (up to age 1 year), at each gestational age in weeks. Routinely recorded data extracted from real-time, point-of-care patient management systems held in the National Neonatal Research Database, Hospital Episode Statistics and Office for National Statistics, for January 2014 to December 2018, will be analysed. Secondary objectives are to assess (1) whether differences in care provided, rather than a focus on LNU/NICU designation, drives gestation-specific outcomes, (2) where care is most cost-effective and (3) what parents' and clinicians' perspectives are on place of care, and how these could guide clinical decision-making. Our findings will be used to develop recommendations, in collaboration with national bodies, to inform clinical practice, commissioning and policy-making. The project is supported by a parent advisory panel and a study steering committee. ETHICS AND DISSEMINATION: Research ethics approval has been obtained (IRAS 212304). Dissemination will be through publication of findings and development of recommendations for care. TRIAL REGISTRATION

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• Journal article
  Tume LN, Arch B, Woolfall K, Latten L, Deja E, Roper L, Pathan N, Eccleson H, Hickey H, Brown M, Beissel A, Andrzejewska I, Gale C, Valla FV, Dorling Jet al., 2019,

  Gastric residual volume measurement in U.K. PICUs: a survey of practice

  , Pediatric Critical Care Medicine, Vol: 20, Pages: 707-713, ISSN: 1529-7535

  Objectives: Despite little evidence, the practice of routine measurement of gastric residual volume to guide both the initiation and delivery of enteral feeding in PICUs is widespread internationally. In light of increased scrutiny of the evidence surrounding this practice, and as part of a trial feasibility study, we aimed to determine enteral feeding and gastric residual volume measurement practices in U.K. PICUs.Design: An online survey to 27 U.K. PICUs.Setting: U.K. PICUs.Subjects: A clinical nurse, senior doctor, and dietician were invited to collaboratively complete one survey per PICU and send a copy of their unit guidelines on enteral feeding and gastric residual volume.Interventions: None.Measurement and Main Results: Twenty-four of 27 units (89%) approached completed the survey. Twenty-three units (95.8%; 23/24) had written feeding guidelines, and 19 units (19/23; 83%) sent their guidelines for review. More units fed continuously (15/24; 62%) than intermittently (9/24; 37%) via the gastric route as their primary feeding method. All but one PICU routinely measured gastric residual volume, regardless of the method of feeding. Eighteen units had an agreed definition of feed tolerance, and all these included gastric residual volume. Gastric residual volume thresholds for feed tolerance were either volume based (mL/kg body weight) (11/21; 52%) or a percentage of the volume of feed administered (6/21; 29%). Yet only a third of units provided guidance about the technique of gastric residual volume measurement.Conclusions: Routine gastric residual volume measurement is part of standard practice in U.K. PICUs, with little guidance provided about the technique which may impact the accuracy of gastric residual volume. All PICUs that defined feed tolerance included gastric residual volume in the definition. This is important to know when proposing a standard practice arm of any future trial of no-routine gastric residual volume measurement in critically ill children.

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• Journal article
  Binder C, Giordano V, Thanhaeuser M, Kreissl A, Huber-Dangl M, Longford N, Haiden N, Berger A, Repa A, Klebermass-Schrehof Ket al., 2019,

  A Mixed Lipid Emulsion Containing Fish Oil and Its Effect on Electrophysiological Brain Maturation in Infants of Extremely Low Birth Weight: A Secondary Analysis of a Randomized Clinical Trial

  , The Journal of Pediatrics, Vol: 211, Pages: 46-53.e2, ISSN: 0022-3476

  ObjectiveTo assess whether parenteral nutrition for infants of extremely low birth weight using a mixed lipid emulsion that contains fish oil influences electrophysiological brain maturation.Study designThe study is a prespecified secondary outcome analysis of a randomized controlled trial of 230 infants of extremely low birth weight receiving a mixed (soybean oil, medium-chain triglycerides, olive oil, and fish oil; intervention) or a soybean oil−based lipid emulsion (control). The study was conducted at a single-level IV neonatal care unit (Medical University Vienna; June 2012 to October 2015). Electrophysiological brain maturation (background activity, sleep−wake cycling, and brain maturational scores) was assessed biweekly by amplitude-integrated electroencephalography (birth to discharge).ResultsA total of 317 amplitude-integrated electroencephalography measurements (intervention: n = 165; control: n = 152) from 121 (intervention: n = 63; control: n = 58) of 230 infants of the core study were available for analysis. Demographic characteristics were not significantly different. By 28 weeks of postmenstrual age, infants receiving the intervention displayed significantly greater percentages of continuous background activity. Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater. Maximum maturational scores were reached 2 weeks earlier in the intervention group (36.4 weeks, 35.4-37.5) compared with the control group (38.4 weeks, 37.1-42.4) (median, IQR; P < .001).ConclusionsUsing a mixed parenteral lipid emulsion that contains fish oil, we found that electrophysiological brain maturation was accelerated in infants who were preterm.

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• Journal article
  Modi N, 2019,

  Information technology infrastructure, quality improvement and research: the UK National Neonatal Research Database

  , Translational pediatrics, Vol: 8, Pages: 193-198, ISSN: 2224-4344

  Technological developments, coupled with strengthened governance and data security have led to increasing recognition of the potential of real-world health data to benefit patient care and health services. Real-world health data are those captured in the course of routine care. Here I describe a mature source of real-world health data, the UK National Neonatal Research Database and provide examples of the many types of uses it supports.

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• Journal article
  Webbe J, Longford N, Uthaya S, Modi N, Gale Cet al., 2019,

  Outcomes following early parenteral nutrition use in preterm neonates: Protocol for an observational study

  , BMJ Open, Vol: 9, Pages: 1-5, ISSN: 2044-6055

  Introduction Preterm babies are among the highest users of parenteral nutrition (PN) of any patient group, but there is wide variation in commencement, duration, and composition of PN and uncertainty around which groups will benefit from early introduction. Recent studies in critically unwell adults and children suggest that harms, specifically increased rates of nosocomial infection, outweigh the benefits of early administration of PN. In this study, we will describe early PN use in neonatal units in England, Wales and Scotland. We will also evaluate if this is associated with differences in important neonatal outcomes in neonates born between 30+0 and 32+6 weeks+days gestation.Methods and analysis We will use routinely collected data from all neonatal units in England, Wales and Scotland, available in the National Neonatal Research Database (NNRD). We will describe clinical practice in relation to any use of PN during the first 7 postnatal days among neonates admitted to neonatal care between 1 January 2012 and 31 December 2017. We will compare outcomes in neonates born between 30+0 and 32+6 weeks+days gestation who did or did not receive PN in the first week after birth using a propensity score-matched approach. The primary outcome will be survival to discharge home. Secondary outcomes will include components of the neonatal core outcome set: outcomes identified as important by former patients, parents, clinicians and researchers.Ethics and dissemination We have obtained UK National Research Ethics Committee approval for this study (Ref: 18/NI/0214). The results of this study will be presented at academic conferences; the UK charity Bliss will aid dissemination to former patients and parents.

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• Journal article
  Shah PS, Lui K, Reichman B, Norman M, Kusuda S, Lehtonen L, Adams M, Vento M, Darlow BA, Modi N, Rusconi F, Hakansson S, San Feliciano L, Helenius KK, Bassler D, Hirano S, Lee SK, 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, 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, Fung G, Harrison A, Synnes A, Ting J, Cieslak Z, Sherlock R, Yee W, Aziz K, Toye J, 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, Mabry 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, Oman H, Toy-Friedman SE, Bar-Oz B, Feldman M, Saad N, Flidel-Rimon O, Weisbrod M, Lubin D, Litmanovitz I, Kngelman 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, Amiznka 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 Aet al., 2019,

  The International Network for Evaluating Outcomes (iNeo) of neonates: evolution, progress and opportunities

  , Translational pediatrics, Vol: 8, Pages: 170-+, ISSN: 2224-4344

  Neonates born very preterm (before 32 weeks’ gestational age), are a significant public health concern because of their high-risk of mortality and life-long disability. In addition, caring for very preterm neonates can be expensive, both during their initial hospitalization and their long-term cost of permanent impairments. To address these issues, national and regional neonatal networks around the world collect and analyse data from their constituents to identify trends in outcomes, and conduct benchmarking, audit and research. Improving neonatal outcomes and reducing health care costs is a global problem that can be addressed using collaborative approaches to assess practice variation between countries, conduct research and implement evidence-based practices. The International Network for Evaluating Outcomes (iNeo) of neonates was established in 2013 with the goal of improving outcomes for very preterm neonates through international collaboration and comparisons. To date, 10 national or regional population-based neonatal networks/datasets participate in iNeo collaboration. The initiative now includes data on >200,000 very preterm neonates and has conducted important epidemiological studies evaluating outcomes, variations and trends. The collaboration has also surveyed >320 neonatal units worldwide to learn about variations in practices, healthcare service delivery, and physical, environmental and manpower related factors and support services for parents. The iNeo collaboration serves as a strong international platform for Neonatal-Perinatal health services research that facilitates international data sharing, capacity building, and global efforts to improve very preterm neonate care.

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• Journal article
  Sakonidou S, Andrzejewska I, Kotzamanis S, Carnegie W, Nakubulwa M, Woodcock T, Modi N, Bell D, Gale Cet al., 2019,

  Better use of data to improve parent satisfaction (BUDS): protocol for a prospective before-and-after pilot study employing mixed methods to improve parent experience of neonatal care

  , BMJ Paediatrics Open, Vol: 3, ISSN: 2399-9772

  Introduction Having a baby that requires neonatal care is stressful and traumatic. Parents often report dissatisfaction with communication of clinical information. In the UK neonatal care data are recorded daily using electronic patient record systems (EPR), from which deidentified data form the National Neonatal Research Database (NNRD). We aim to evaluate the impact of sharing neonatal EPR data with parents, on parent-reported satisfaction, parent–staff interactions, staff workload and data completeness.Methods A prospective, before-and-after, mixed-method study. Participants are parents of inpatient babies (maximum 90) and staff in a tertiary neonatal intensive care unit, London, UK. The intervention was developed by former neonatal parents, neonatologists and neonatal nurses: a communication tool for parents comprising individualised, written, daily infant updates for parents, derived from EPR data. The intervention will be provided to parents over 6 weeks. Plan-Do-Study-Act cycles will inform the tool’s iterative development and improvement. The tool’s impact will be measured using a validated parent survey, staff survey, data completeness measures and interviews.Analysis Primary outcome: parent satisfaction ‘with communication of clinical information and involvement in care’. Secondary outcomes: parent–staff interactions, staff workload, data completeness. Baseline survey data will be obtained from clinical service evaluation preceding the intervention. Baseline data completeness will be derived from the NNRD. During the intervention, surveys will be administered biweekly and data completeness assessed daily. We will analyse outcomes using run charts and partially paired statistical tests. Parent and staff interviews will explore information exchange and the communication tool’s impact.Discussion This study will evaluate the impact of a parent co-designed intervention on communication with parents in neonatal care and

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• Conference paper
  Duffy JMN, Hooft JT, Gale C, Brown M, Grobman W, Fitzpatrick R, Karumanchi AS, Lucas N, Magee L, Mol B, Stark M, Thangaratinam S, Wilson M, Von Dadelszen P, Williamson PR, Khan K, Ziebland S, McManus RJet al., 2019,

  Developing a core outcome set for future pre-eclampsia research: an international consensus development study involving 283 healthcare professionals, 41 researchers and 112 patients from 55 countries

  , Publisher: WILEY, Pages: 67-67, ISSN: 1470-0328
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• Journal article
  Ojha S, Dorling J, Battersby C, Longford N, Gale CRKet al., 2019,

  Optimising nutrition during therapeutic hypothermia

  , Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 104, Pages: F230-F231, ISSN: 1359-2998

  There is little evidence to inform provision of enteral or parenteral nutrition to infants with hypoxic ischaemic encephalopathy (HIE) during and soon after therapeutic hypothermia; as a consequence, clinical practice is both variable and changing. A 2014 UK survey found that 79% (33 of 42) of responding neonatal units routinely withheld enteral nutrition during cooling; 3 years later, a similar survey found that 41% (20 of 49) of responding units reported withholding enteral nutrition.1 The latter study also reports wide variation in how, when and how much to feed, and in the use of parenteral nutrition. Internationally, practice is even more variable: withholding enteral feeds is practised almost universally2 in some countries, while in others, milk feeding during hypothermia is routine.3 Here we discuss the limited evidence available to inform enteral and parenteral nutrition during therapeutic hypothermia.

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• Journal article
  Li Y, Liu X, Modi N, Uthaya Set al., 2019,

  Impact of breast milk intake on body composition at term in very preterm babies: secondary analysis of the Nutritional Evaluation and Optimisation in Neonates randomised controlled trial

  , ARCHIVES OF DISEASE IN CHILDHOOD-FETAL AND NEONATAL EDITION, Vol: 104, Pages: F306-F312, ISSN: 1359-2998
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  • Citations: 11

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