评估出生胎龄<29 周的婴儿行为功能是否通过ω-3 长链多不饱和脂肪酸改善的方案：一项随机对照试验的随访。

Protocol for assessing if behavioural functioning of infants born <29 weeks' gestation is improved by omega-3 long-chain polyunsaturated fatty acids: follow-up of a randomised controlled trial.

机构信息

SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia

School of Psychology and Discipline of Paediatrics, Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, South Australia, Australia.

出版信息

BMJ Open. 2021 May 5;11(5):e044740. doi: 10.1136/bmjopen-2020-044740.

DOI:10.1136/bmjopen-2020-044740

PMID:33952546

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8103387/

Abstract

INTRODUCTION

During the last trimester of pregnancy, the fetal brain undergoes a rapid growth spurt and accumulates essential nutrients including docosahexaenoic acid (DHA). This takes place ex-utero for infants born <29 weeks' gestation, without the in-utero provisions of DHA. Infants born <29 weeks' are more likely to experience behavioural and emotional difficulties than their term-born counterparts. It has been hypothesised that supplementing preterm infants with dietary DHA may alleviate insufficiency and subsequently prevent or minimise behavioural problems. This protocol describes a follow-up of infants born <29 weeks gestation who were enrolled in a randomised controlled trial (RCT) of DHA supplementation. We aim to determine whether DHA supplementation improves the behaviour, and general health of these infants.

METHODS AND ANALYSIS

Infants born <29 weeks' gestation were enrolled in a multicentre blinded RCT of enteral DHA supplementation. Infants were randomised to receive an enteral emulsion that provided 60 mg/kg/day of DHA or a control emulsion commenced within the first 3 days of enteral feeding, until 36 weeks' postmenstrual age or discharge home, whichever occurred first. Families of surviving children (excluding those who withdrew from the study) from the Australian sites (up to 955) will be invited to complete a survey. The survey will include questions regarding child behavioural and emotional functioning, executive functioning, respiratory health and general health. We hypothesise that the DHA intervention will have a benefit on the primary outcome, parent-rated behaviour and emotional status as measured using the Total Difficulties score of the Strengths and Difficulties Questionnaire. Detecting a 2-point difference between groups (small effect size of 0.25 SD) with 90% power will require follow-up of 676 participants.

ETHICS AND DISSEMINATION

The Women's and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/16/WCHN/184). Results will be disseminated in peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER

ACTRN12612000503820.

摘要

简介

在妊娠的最后三个月，胎儿大脑经历快速生长突增，并积累包括二十二碳六烯酸（DHA）在内的必需营养物质。对于妊娠 29 周以下出生的婴儿来说，这是在子宫外进行的，而 DHA 则无法在子宫内提供。与足月出生的婴儿相比，妊娠 29 周以下出生的婴儿更有可能出现行为和情绪问题。有人假设，给早产儿补充膳食 DHA 可能会缓解不足，并随后预防或最小化行为问题。本方案描述了对参加二十二碳六烯酸补充剂随机对照试验（RCT）的妊娠 29 周以下出生的婴儿进行的随访。我们旨在确定 DHA 补充是否能改善这些婴儿的行为和整体健康状况。

方法和分析

妊娠 29 周以下的婴儿参加了一项多中心、双盲、RCT 的肠内 DHA 补充试验。婴儿被随机分配接受一种肠内乳剂，该乳剂每天提供 60mg/kg 的 DHA，或在开始肠内喂养的前 3 天内接受对照乳剂，直到达到 36 周的校正胎龄或出院回家，以先发生者为准。来自澳大利亚站点（最多 955 名）的幸存儿童（不包括退出研究的儿童）的家长将被邀请完成一项调查。该调查将包括有关儿童行为和情绪功能、执行功能、呼吸健康和整体健康的问题。我们假设 DHA 干预将对主要结局产生益处，即家长评定的行为和情绪状况，采用《长处与困难问卷》的总困难评分进行测量。要检测到两组之间 2 分的差异（0.25 标准差的小效应量），需要对 676 名参与者进行随访。