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• 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
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• 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, ISSN: 1745-6215

  <jats:title>Abstract</jats:title> <jats:p>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. 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.ConclusionHigh 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.RegistrationPROSPERO registration number CRD42016046138, registered prospectively 17 th August 2016</jats:p>

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• 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

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• Conference paper
  Juszczak E, Kwakkenbos L, McCall S, Imran M, Hemkens LG, Zwarenstein M, Frobert O, Relton C, Sampson M, Thabane CL, Benchimol EI, Campbell MK, Torgerson DJ, Erlinge D, Rice DB, Langan S, Mc Cord KA, van Staa TP, Moher D, Verkooijen HM, Uher R, Worron-Sauve MB, Boutron I, Ravaud P, Thombs BD, Gale Cet al., 2019,

  Introducing the CONsolidated Standards of Reporting Trials (CONSORT) statement for randomised controlled trials (RCTs) using cohorts and routinely collected health data

  , Publisher: BMC
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• 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

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• 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.

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• Journal article
  Caplan MS, Underwood MA, Modi N, Patel R, Gordon PV, Sylvester KG, McElroy S, Manzoni P, Gephart S, Chwals WJ, Turner MA, Davis JM, Allen M, Baer G, Besner G, Canvasser J, Chaaban H, Clay R, Connolly E, Davis JM, Duchon J, Eklund W, Ferguson J, Gadepalli S, Good M, Grogan C, Hudson L, Khashu M, Kim J, Lotze A, Mangili A, Markel T, Martin L, Miyazawa T, Neu J, Noel G, Portman R, Rosito S, Schwartz A, Scottoline B, Seo S, Stromberg S, Treem W, Umberger E, Warren T, West Aet al., 2019,

  Necrotizing enterocolitis: using regulatory science and drug development to improve outcomes

  , Journal of Pediatric Ophthalmology and Strabismus, Vol: 212, Pages: 208-215.e1, ISSN: 0022-345X
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• 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 (

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  Ojha S, Battersby C, Longford NT, Jeyakumaran D, Dorling J, Gale Cet al., 2019,

  OPTIMISING NURTITION DURING THERAPEUTIC HYPOTHERMIA: AN OBSERVATIONAL STUDY USING PROPENSITY SCORE MATCHING

  , 3rd Congress of Joint European Neonatal Societies (jENS), Publisher: NATURE PUBLISHING GROUP, Pages: 20-21, ISSN: 0031-3998
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• 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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  • Citations: 1

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