Pell Lisa G, Bassani Diego G, Nyaga Lucy, Njagi Isaac, Wanjiku Catherine, Thiruchselvam Thulasi, Macharia William, Minhas Ripudaman S, Kitsao-Wekulo Patricia, Lakhani Amyn, Bhutta Zulfiqar A, Armstrong Robert, Morris Shaun K
Centre for Global Child Health, The Hospital for Sick Children, Toronto, Canada.
Department of Community Health, Faculty of Health Sciences, Aga Khan University, Mombasa, Kenya.
BMC Pregnancy Childbirth. 2016 Sep 8;16(1):265. doi: 10.1186/s12884-016-1042-5.
Each year, more than 200 million children under the age of 5 years, almost all in low- and middle-income countries (LMICs), fail to achieve their developmental potential. Risk factors for compromised development often coexist and include inadequate cognitive stimulation, poverty, nutritional deficiencies, infection and complications of being born low birthweight and/or premature. Moreover, many of these risk factors are closely associated with newborn morbidity and mortality. As compromised development has significant implications on human capital, inexpensive and scalable interventions are urgently needed to promote neurodevelopment and reduce risk factors for impaired development.
METHOD/DESIGN: This cluster randomized trial aims at evaluating the impact of volunteer community health workers delivering either an integrated neonatal survival kit, an early stimulation package, or a combination of both interventions, to pregnant women during their third trimester of pregnancy, compared to the current standard of care in Kwale County, Kenya. The neonatal survival kit comprises a clean delivery kit (sterile blade, cord clamp, clean plastic sheet, surgical gloves and hand soap), sunflower oil emollient, chlorhexidine, ThermoSpot(TM), Mylar infant sleeve, and a reusable instant heater. Community health workers are also equipped with a portable hand-held electric scale. The early cognitive stimulation package focuses on enhancing caregiver practices by teaching caregivers three key messages that comprise combining a gentle touch with making eye contact and talking to children, responsive feeding and caregiving, and singing. The primary outcome measure is child development at 12 months of age assessed with the Protocol for Child Monitoring (Infant and Toddler version). The main secondary outcome is newborn mortality.
This study will provide evidence on effectiveness of delivering an innovative neonatal survival kit and/or early stimulation package to pregnant women in Kwale County, Kenya. Study findings will help inform policy on the most appropriate interventions for promoting healthy brain development and reduction of newborn morbidity and mortality in Kenya and other similar settings.
ClinicalTrial.gov NCT02208960 (August 1, 2014).
每年，超过2亿5岁以下儿童无法充分发挥其发育潜力，这些儿童几乎全部来自低收入和中等收入国家（LMICs）。发育受损的风险因素往往并存，包括认知刺激不足、贫困、营养缺乏、感染以及低出生体重和/或早产带来的并发症。此外，这些风险因素中的许多都与新生儿发病率和死亡率密切相关。由于发育受损对人力资本有重大影响，因此迫切需要廉价且可扩展的干预措施来促进神经发育并减少发育受损的风险因素。
方法/设计：这项整群随机试验旨在评估，与肯尼亚夸勒县目前的标准护理相比，由社区志愿者卫生工作者在孕妇妊娠晚期提供综合新生儿生存包、早期刺激方案或两种干预措施的组合，所产生的影响。新生儿生存包包括一个清洁分娩包（无菌刀片、脐带夹、清洁塑料布、手术手套和洗手液）、葵花籽油润肤剂、洗必泰、热感贴（ThermoSpot™）、聚酯薄膜婴儿睡袋和一个可重复使用的即时加热器。社区卫生工作者还配备了便携式手持电子秤。早期认知刺激方案侧重于通过向照顾者传授三条关键信息来加强照顾者的做法，这三条关键信息包括轻柔触摸并与儿童进行眼神交流和交谈、响应式喂养和照顾以及唱歌。主要结局指标是使用儿童监测方案（婴幼儿版）评估的12个月大儿童的发育情况。主要次要结局是新生儿死亡率。
本研究将为在肯尼亚夸勒县向孕妇提供创新的新生儿生存包和/或早期刺激方案的有效性提供证据。研究结果将有助于为肯尼亚和其他类似环境中促进健康大脑发育以及降低新生儿发病率和死亡率的最合适干预措施提供政策依据。
ClinicalTrial.gov NCT02208960（2014年8月1日）。
