Department of Paediatrics and Child Health, Obafemi Awolowo University, Ile-Ife, 220005, Nigeria.
Komfo Anokye Teaching Hospital, P.O. Box 1934, Adum, Kumasi, Ghana.
Trials. 2023 Apr 10;24(1):265. doi: 10.1186/s13063-023-07192-5.
Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment.
This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat.
Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors.
Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369.
早产或低出生体重是新生儿死亡的最大单一原因，但通过新生儿护理干预措施，包括袋鼠式护理（KMC），可以降低死亡率。此前，世界卫生组织（WHO）协调的一项多国家随机对照试验报告称，与出生几天后在婴儿被认为临床稳定时开始持续 KMC 相比，出生后立即开始持续 KMC 可显著提高生存率。尚未研究这种生存优势是否会导致更高的神经发育障碍发病率，或者立即开始 KMC 是否也会对认知发展产生有益影响。因此，我们假设通过前瞻性随访已经参加立即开始 KMC 试验的婴儿，评估他们的生长和神经发育情况，接触立即开始 KMC 的低出生体重婴儿的神经发育损伤率将低于传统 KMC 治疗的婴儿。
这项前瞻性队列研究将纳入主要 WHO 立即开始 KMC 试验中存活的新生儿。主要试验和这项随访研究正在南亚和撒哈拉以南非洲的五个低收入和中等收入国家进行。比较神经发育障碍风险的估计样本量总计为 2200 名儿童。主要结局将包括脑瘫、听力障碍、视力障碍、精神和运动发育以及癫痫的发生率，并在 3 岁时进行评估。分析将采用意向治疗。
立即开始 KMC 可能会降低与低出生体重相关的并发症，如呼吸疾病、体温过低、低血糖和感染，这些并发症可能导致神经认知发育受损。神经保护也可能通过改善生理稳定来介导，这可能导致神经通路更好地成熟，降低缺氧风险，对父母产生积极影响，改善睡眠周期和应激反应。本研究将通过调查对幸存者神经发育障碍的长期影响，来评估 KMC 的总体影响。
印度临床试验注册处 CTRI/2019/11/021899。于 2019 年 11 月 6 日注册。母体试验的试验注册：ACTRN12618001880235；印度临床试验注册处：CTRI/2018/08/015369。
