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  • Journal article
    Uthaya SN, Liu X, Babalis D, Doré C, Warwick J, Bell J, Thomas E, Ashby D, Durighel G, Ederies A, Yanez-Lopez M, Modi Net al., 2016,

    Nutritional Evaluation and Optimisation in Neonates (NEON): a randomised double-blind controlled trial of amino-acid regimen and intravenous lipid composition in preterm parenteral nutrition

    , American Journal of Clinical Nutrition, Vol: 103, Pages: 1443-1452, ISSN: 1938-3207

    BackgroundParenteral nutrition is central to the care of very immature infants. Current international recommendations favour higher amino-acid intakes and fish oil-containing lipid emulsions. ObjectiveThe aim of this two-by-two factorial, double-blind multicentre randomised controlled trial was to compare the effect of high (immediate Recommended Daily Intake: Imm-RDI) versus low (incremental introduction: Inc-AA) parenteral amino-acid delivery, commenced within 24 hours of birth, on body composition, and a multi-component lipid emulsion containing 30% soy bean oil, 30% medium chain triglycerides, 25% olive oil and 15% fish oil (SMOF) versus soybean oil based lipid emulsion (SO) on Intra-Hepato-Cellular Lipid (IHCL) content. ResultsWe randomised 168 infants born <31 weeks gestation. We evaluated outcomes at term in 133 infants. There were no significant differences between Imm-RDI and Inc-AA groups for non-adipose mass (adjusted mean difference (95% CI): 1.0g (-108, 111) p=0.98) or between SMOF and SO groups for IHCL (adjusted mean ratio SMOF:SO (95% CI): 1.1 (0.8, 1.6) p=0.58). SMOF does not affect IHCL content. There was a significant interaction (p=0.05) between the two interventions for non-adipose mass. There were no significant interactions between group differences for either primary outcome measure after adjusting for additional confounders. Imm-RDI infants were more likely than Inc-AA infants to have blood urea nitrogen levels greater than 7mmol/l or 10mmol/l respectively (75% vs 49%; p<0.01 and 49% vs 18%; p<0.01). Head circumference at term was smaller in the Imm-RDI group (mean difference (95% CI): -0.8cm (-1.5, -0.1) p= 0.02). There were no significant differences in any pre-specified secondary outcomes including adiposity, liver function tests, incidence of conjugated hyperbilirubinaemia, weight, length, mortality and brain volumes. ConclusionsImmediate delivery of Recommended Daily Intake of parenteral amino-acids does not benefit body compo

  • Journal article
    Modi N, 2016,

    Neena Modi: Dogged, determined, driven

    , BMJ, Vol: 353, ISSN: 0959-8138
  • Journal article
    Modi N, 2016,

    Time to bring fetal growth assessment into the 21st century

    , BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Vol: 123, ISSN: 1470-0328
  • Journal article
    Gale CRK, Morris I, 2016,

    The UK National Neonatal Research Database: using neonatal data for research, quality improvement and more

    , Archives of Disease in Childhood-Education and Practice Edition, Vol: 101, Pages: 216-218, ISSN: 1743-0593

    Electronic data are increasingly recorded in clinical practice. Just as advances in genetics have gradually led to clinical benefit1 so too are ‘big data’ bringing tangible advances to patient care.2The UK has a long history of using electronic neonatal data for research and is now in the enviable position of having electronic patient data on all admissions to National Health Service (NHS) neonatal units in England, Wales and Scotland. This national resource, the National Neonatal Research Database (NNRD), is available for research, audit, benchmarking and quality improvement. Here, we provide an overview of how data entered into an electronic system (Badger.net; Clevermed Ltd) as a component of day-to-day care, are used to form the NNRD and how this can be used by health professionals.

  • Report
    Ougham K, Modi N, 2016,

    The NDAU report 2015

    , The NDAU report 2015, London, UK, Publisher: The Neonatal Data Analysis Unit, Imperial College London, 4
  • Journal article
    Watson SI, Arulampalam W, Petrou S, Marlow N, Morgan AS, Draper ES, Modi Net al., 2016,

    The effects of a one-to-one nurse-to-patient ratio on the mortality rate in neonatal intensive care: a retrospective, longitudinal, population-based study

    , Archives of Disease in Childhood-Fetal and Neonatal Edition, Vol: 101, Pages: F195-F200, ISSN: 1468-2052

    Objective To estimate the effect of the provision of a one-to-one nurse-to-patient ratio on mortality rates in neonatal intensive care units.Design A population-based analysis of operational clinical data using an instrumental variable method.Setting National Health Service neonatal units in England contributing data to the National Neonatal Research Database at the Neonatal Data Analysis Unit and participating in the Neonatal Economic, Staffing, and Clinical Outcomes Project.Participants 43 tertiary-level neonatal units observed monthly over the period January 2008 to December 2012.Intervention Proportion of neonatal intensive care days or proportion of intensive care admissions for which one-to-one nursing was provided.Outcomes Monthly in-hospital intensive care mortality rate.Results Over the study period, the provision of one-to-one nursing in tertiary neonatal units declined from a median of 9.1% of intensive care days in 2008 to 5.9% in 2012. A 10 percentage point decrease in the proportion of intensive care days on which one-to-one nursing was provided was associated with an increase in the in-hospital mortality rate of 0.6 (95% CI 1.2 to 0.0) deaths per 100 infants receiving neonatal intensive care per month compared with a median monthly mortality rate of 4.5 deaths per 100 infants per month. The results remained robust to sensitivity analyses that varied the estimation sample of units, the choice of instrumental variables, unit classification and the selection of control variables.Conclusions Our study suggests that decreases in the provision of one-to-one nursing in tertiary-level neonatal intensive care units increase the in-hospital mortality rate.

  • Conference paper
    Parkinson JRC, Hyde MJ, Modi N, 2016,

    The search for biomarkers of long-term outcome after preterm birth

    , 84th Nestle-Nutrition-Institute Workshop on Next-Generation Nutritional Biomarkers to Guide Better Health Care, Publisher: Karger, Pages: 71-80, ISSN: 1664-2147

    Preterm birth and survival rates are rising globally, and consequently there is a growing necessity to safeguard life-long health. Epidemiological and other studies from around the world point to a higher risk of adverse adult health outcomes following preterm birth. These reports encompass morbidities in multiple domains, poorer reproductive health, and reduced longevity. The contributions of genetic inheritance, intrauterine exposures, and postnatal care practices to this altered adult phenotype are not known. Early detection is essential to implement preventive measures and to test protective antenatal and neonatal interventions to attenuate aberrant health trajectories. A satisfactory biomarker of outcome must be predictive of later functional health and ideally remain stable over the period from infancy to childhood and adult life. To date, blood pressure is the index that best fulfils these criteria. High throughput ‘omic' technologies may identify biomarkers of later outcome and health risk. However, their potential can only be realized with initial investment in large, longitudinal cohort studies, which couple serial metabolomic profiling with functional health assessments across the life course.

  • Journal article
    Raban S, Santhakumaran S, Keraan Q, Joolay Y, Uthaya S, Horn A, Modi N, Harrison Met al., 2016,

    A randomised controlled trial of high vs low volume initiation and rapid vs slow advancement of milk feeds in infants with birthweights 1000 g in a resource-limited setting

    , Paediatrics and International Child Health, Vol: 36, Pages: 288-295, ISSN: 2046-9047

    Background: Optimal feeding regimens for infants ≤ 1000 g have not been established and are a global healthcare concern.Aims and objectives: A controlled trial to establish the safety and efficacy of high vs low volume initiation and rapid vs slow advancement of milk feeds in a resource-limited setting was undertaken.Methods: Infants ≤ 1000 g birthweight were randomised to one of four arms, either low (4 ml/kg/day) or high (24 ml/kg/day) initiation and either slow (24 ml/kg/day) or rapid (36 ml/kg/day) advancement of exclusive feeds of human milk (mother’s or donor) until a weight of 1200 g was reached. After this point, formula was used to supplement insufficient mother’s milk. The primary outcome was time to reach 1500 g.Results: infants were recruited (51: low/slow; 47: low/rapid; 52: high/slow; 50: high/rapid). Infants on rapid advancement regimens reached 1500 g most rapidly (hazard ratio 1.48, 95% CI 1.05–2.09, P=0.03). The rapid advancement groups also regained birthweight more rapidly (hazard ratio 1.77, 95% CI 1.26–2.50, P=0.001). There was no apparent effect of high vs low initiation volumes but there was some evidence of interaction between interventions. There were no significant differences in other secondary outcomes, including necrotising enterocolitis, feed intolerance and late-onset sepsis.Conclusions: In this small pilot study, higher initiation feed volumes and larger daily increments appeared to be well tolerated and resulted in more rapid early weight gain. These data provide justification for a larger study in resource-limited settings to address mortality, necrotising enterocolitis and other important outcomes.

  • Journal article
    Gale C, Modi N, 2015,

    Neonatal randomised point-of-care trials are feasible and acceptable in the UK: results from two national surveys

    , Archives of Disease in Childhood-Fetal and Neonatal Edition, Vol: 101, Pages: 86-86, ISSN: 1468-2052
  • Journal article
    Mazmanyan P, Mellor K, Dore CJ, Modi Net al., 2015,

    A randomised controlled trial of flow driver and bubble continuous positive airway pressure in preterm infants in a resource-limited setting

    , Archives of Disease in Childhood. Fetal and Neonatal Edition, Vol: 101, Pages: 16-20, ISSN: 1359-2998

    Objectives The variable-flow flow driver (FD; EME) and continuous-flow bubble (Fisher-Paykel) continuous positive airway pressure (CPAP) systems are widely used. As these differ in cost and technical requirements, determining comparative efficacy is important particularly where resources are limited.Design We performed a randomised, controlled, equivalence trial of CPAP systems. We specified the margin of equivalence as 2 days. We analysed binary variables by logistical regression adjusted for gestation, and log transformed continuous variables by multiple linear regression adjusted for gestation, sex and antenatal steroids.Setting A neonatal unit with no blood gas analyser or surfactant availability and limited X-ray and laboratory facilitiesPatients Neonates <37 weeks of gestation.Interventions We provided CPAP at delivery followed by randomisation to FD or bubble (B).Outcomes Primary outcome included total days receiving CPAP; secondary outcomes included days receiving CPAP, supplemental oxygen, ventilation, death, pneumothorax and nasal excoriation.Results We randomised 125 infants (B 66, FD 59). Differences in infant outcomes on B and FD were not statistically significant. The median (range) for CPAP days for survivors was B 0.8 (0.04 to 17.5), FD 0.5 (0.04 to 5.3). B:FD (95% CI) ratios were CPAP days 1.3 (0.9 to 2.1), CPAP plus supplementary oxygen days 1.2 (0.7 to 1.9). B:FD (95% CI) ORs were death 2.3 (0.2 to 28), ventilation 2.1 (0.5 to 9), nasal excoriation 1.2 (0.2 to 8) and pneumothorax 2.4 (0.2 to 26).Conclusions In a resource-limited setting we found B CPAP equivalent to FD CPAP in the total number of days receiving CPAP within a margin of 2 days.

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