Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching.
Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching.
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DOI：
10.1136/bmjopen-2018-026739
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发表时间：
2018-10-23
期刊：
影响因子：
2.9
通讯作者：
Gale C
中科院分区：
文献类型：
--
作者：
Battersby C;Longford N;Patel M;Selby E;Ojha S;Dorling J;Gale C
治疗性低温是妊娠≥36周的缺氧缺血性脑病（HIE）婴儿的标准治疗;治疗性低温期间的最佳营养缺乏共识。这导致这些婴儿的肠内喂养和肠外营养（PN）的变化。在这项研究中，我们的目的是确定最佳的肠内营养和PN策略，新生儿缺氧缺血性脑病在治疗低温。我们将使用英国（UK）国家新生儿研究数据库（NNRD）中常规记录的电子患者数据进行回顾性队列研究。我们将从2008年1月1日至2016年12月31日期间出生的胎龄≥36周的婴儿中提取数据，这些婴儿在英格兰，威尔士和苏格兰的新生儿病房接受治疗性低温至少72小时或在治疗性低温期间死亡。我们将组成匹配组，以进行两项比较：（1）在治疗性低温期间，肠内喂养婴儿与非肠内喂养婴儿之间NEC的风险;（2）在治疗性低温期间，接受静脉葡萄糖（无任何PN）的婴儿与接受PN的婴儿之间迟发性血流感染的风险。还将检查以下次要结局：生存率、住院时间、出院时母乳喂养、低血糖、完全肠内喂养时间和生长。比较组将使用倾向评分匹配在人口统计学、母体、婴儿和组织因素上进行匹配。在这项研究中，我们将使用NNRD中保存的去身份化数据，NNRD是一个已建立的国家人口数据库;父母可以选择退出NNRD中保存的婴儿数据。本研究获得了研究特定研究伦理委员会的批准（East Midlands莱斯特中心，17/EM/0307）。这些结果将有助于为接受低温治疗的HIE婴儿提供最佳营养管理信息;结果将通过会议、科学出版物和与父母合作制作的以父母为中心的信息传播。NCT 03278847;预结果，ISRCTN 47404296;预结果。
Therapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia. We will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching. In this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby’s data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents. NCT03278847; pre-results, ISRCTN47404296; pre-results.
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影响因子：
2.5
作者：
Chang, Lilly L.;Wynn, James L.;Weiss, Michael D.
通讯作者：
Weiss, Michael D.
影响因子：
2.6
作者：
Hazeldine, Beth;Thyagarajan, Balamurugan;Chakkarapani, Elavazhagan
通讯作者：
Chakkarapani, Elavazhagan
影响因子：
4.7
作者：
Walter, E.;Liu, F. X.;Sondhi, S.
通讯作者：
Sondhi, S.
影响因子：
7.2
作者：
Hemkens, Lars G.;Benchimol, Eric I.;Langan, Sinead M.;Briel, Matthias;Kasenda, Benjamin;Januel, Jean-Marie;Herrett, Emily;von Elm, Erik
通讯作者：
von Elm, Erik
DOI：
10.1136/archdischild-2014-306284
发表时间：
2015-11
期刊：
Archives of disease in childhood. Fetal and neonatal edition
影响因子：
--
作者：
Hassell KJ;Ezzati M;Alonso-Alconada D;Hausenloy DJ;Robertson NJ
通讯作者：
Robertson NJ