Mater Research Institute, Faculty of Medicine, The University of Queensland, South Brisbane, Queensland, Australia.
Neonatal Critical Care Unit, Mater Mothers' Hospitals, South Brisbane, Queensland, Australia.
Trials. 2023 Apr 22;24(1):290. doi: 10.1186/s13063-023-07224-0.
The Taste And Smell To Enhance nutrition (TASTE) trial investigated the effects of smell and taste of milk with tube feeding compared to routine care on the growth of preterm infants. There was no difference between groups in growth (weight, head circumference, length) z-scores at discharge from the hospital. Infants in the intervention group had higher head circumference and length z-scores at 36 weeks postmenstrual age, both secondary outcomes. The objective of this follow-up study is to assess 2-year neurodevelopmental and growth outcomes after exposure of preterm infants to the smell and taste of milk with tube feeding compared to routine care.
This is a neurodevelopmental follow-up study of a two-center, placebo-controlled randomized trial. Infants born before 29 weeks postmenstrual age and/or with a birth weight of less than 1250 g were randomized to smell and taste of milk with each tube feed or routine care. The current follow-up assessed the 2-year neurodevelopmental and growth outcomes of participants of the TASTE trial discharged from the hospital (n = 334). The primary outcome is survival free of any major neurodevelopmental impairment comprising any moderate/severe cerebral palsy (Gross Motor Function Classification System score II-V), Bayley Scales of Infant and Toddler Development, Third/Fourth Edition (Bayley-III/Bayley-4) motor, cognitive, or language scores < -2SD, blindness, or deafness at 2 years of age. Other outcomes include death, breastfeeding within the first year, and respiratory support, oral feeding, and anthropometric parameters at 2 years of age. The Human Research Ethics Committees of Mater Misericordiae Limited and the Royal Women's Hospital approved the TASTE trial including the neurodevelopmental follow-up described in this protocol.
For patients and their families, the neurodevelopmental outcomes of preterm infants are of utmost importance. Consequently, they should be investigated following any interventional study performed during the newborn period. Furthermore, improved weight gain and head growth in the hospital are associated with better long-term neurodevelopmental outcomes. Smelling and tasting of milk is an uncomplicated and cost-effective intervention that may improve the growth and neurodevelopmental outcomes of preterm infants. Potential limitations affecting this follow-up study, caused by the COVID-19 pandemic, are anticipated and discussed in this protocol.
Name of the registry: Australian and New Zealand Clinical Trials Registry; Registration number: ACTRN12617000583347 ; Registration date: 26 April 2017.
味觉和嗅觉增强营养（TASTE）试验研究了与常规护理相比，管饲牛奶的气味和味道对早产儿生长的影响。出院时，两组在生长（体重、头围、身长）Z 评分方面无差异。干预组婴儿在 36 孕周时的头围和身长 Z 评分更高，这两个都是次要结果。本随访研究的目的是评估在接触管饲牛奶的气味和味道后，与常规护理相比，早产儿在 2 岁时的神经发育和生长结局。
这是一项为期 2 年的多中心、安慰剂对照随机试验的神经发育随访研究。出生胎龄小于 29 周和/或出生体重小于 1250 克的婴儿被随机分配到每管饲奶时接受气味和味道刺激或常规护理。目前的随访评估了 TASTE 试验中出院（n=334）的参与者的 2 年神经发育和生长结局。主要结局是在 2 岁时无任何主要神经发育障碍（任何中度/重度脑瘫（粗大运动功能分类系统评分 II-V）、贝利婴幼儿发育量表第三/四版（Bayley-III/Bayley-4）运动、认知或语言评分< -2SD、失明或耳聋）的存活率。其他结局包括死亡、出生后 1 年内母乳喂养、2 岁时呼吸支持、口服喂养和人体测量参数。Mater Misericordiae Limited 和皇家妇女医院的人体研究伦理委员会批准了 TASTE 试验，包括本方案中描述的神经发育随访。
对于患者及其家属而言，早产儿的神经发育结局至关重要。因此，应在新生儿期进行任何干预性研究后进行调查。此外，住院期间体重增加和头围增长较好与长期神经发育结局较好相关。嗅觉和味觉是一种简单且具有成本效益的干预措施，可改善早产儿的生长和神经发育结局。本方案中讨论了预期可能会对这项随访研究产生影响的、由 COVID-19 大流行引起的潜在局限性。
注册名称：澳大利亚和新西兰临床试验注册中心；注册号：ACTRN12617000583347；注册日期：2017 年 4 月 26 日。
