Piper Joe D, Mazhanga Clever, Mwapaura Marian, Mapako Gloria, Mapurisa Idah, Mashedze Tsitsi, Munyama Eunice, Kuona Maria, Mashiri Thombizodwa, Sibanda Kundai, Matemavi Dzidzai, Tichagwa Monica, Nyoni Soneni, Saidi Asinje, Mangwende Manasa, Mbewe Gabriel, Chidhanguro Dzivaidzo, Mpofu Eddington, Tome Joice, Mutasa Batsirai, Chasekwa Bernard, Njovo Handrea, Nyachowe Chandiwana, Muchekeza Mary, Sauramba Virginia, Gladstone Melissa J, Wells Jonathan C, Allen Elizabeth, Moulton Lawrence H, Smuk Melanie, Humphrey Jean H, Langhaug Lisa F, Tavengwa Naume V, Ntozini Robert, Prendergast Andrew J
Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.
Blizard Institute, Queen Mary University of London, London, UK.
EClinicalMedicine. 2024 Nov 22;78:102946. doi: 10.1016/j.eclinm.2024.102946. eCollection 2024 Dec.
Few trials have explored long-term effects of interventions designed to reduce child stunting. We evaluated school-age outcomes in rural Zimbabwean children who received cluster-randomised water, sanitation and hygiene (WASH) and/or infant and young child feeding (IYCF) interventions from pregnancy up to 18 months of age.
The Sanitation Hygiene Infant Nutrition Efficacy (SHINE) trial enrolled pregnant women from two rural Zimbabwean districts (Chirumanzu and Shurugwi) between 2012 and 2015, and cluster-randomised them using a 2 × 2 factorial design to standard-of-care, WASH, IYCF, or combined WASH & IYCF, with a co-primary outcome of height-for-age Z-score and haemoglobin at 18 months (clinicaltrials.govNCT01824940). Children who were HIV-unexposed, age 7 years, and still living in Shurugwi district were eligible for this follow-up study (registered at PACTR 202201828512110) and measured between 1st April 2021 and 30th September 2022. The primary outcome at 7 years was cognitive function using the Kaufman Assessment Battery for Children (KABC-II). Secondary outcomes were executive function, literacy and numeracy, fine motor skills, socioemotional function, handgrip strength, broad jump distance, shuttle-run test distance, anthropometry, lean mass index, and skinfold thicknesses. Study nurses conducting assessments were blinded to intervention arm. Analysis followed a pre-registered statistical analysis plan. Intention-to-treat analyses using generalized estimating equations were used to assess the long-term effects of WASH and IYCF on each outcome, leveraging the factorial trial design. A pre-specified subgroup analysis by child sex was also performed.
Among 3989 HIV-negative women, 3676 children were assessed at age 18 months; of these, 1002 (510 female) were assessed at mean (SD) age 7.3 (0.2) years. There was no effect of IYCF or WASH on the KABC-II score or secondary cognitive outcomes, except a small improvement in socioemotional function in WASH arms (-0.98 points, 95% CI -1.73, -0.22, p = 0.01). Children in IYCF arms had higher handgrip strength (0.28 Kg, 95% CI 0.02, 0.53, p = 0.03); however, in the pre-specified subgroup analysis, improved handgrip strength was seen only in boys (0.53 Kg, 95% CI 0.19, 0.87 p = 0.002). There were no significant effects of either intervention on other outcomes.
Early-life IYCF and WASH led to few functional benefits by school-age. Interventions that are more comprehensive, delivered for longer, and include nurturing care should be considered to improve long-term cognitive and physical function.
Wellcome [220671/Z/20/Z, 108065/Z/15/Z]; NIH [R61HD103101]; Thrasher [15250]; and IMMANA [3.02].
很少有试验探讨旨在减少儿童发育迟缓的干预措施的长期效果。我们评估了津巴布韦农村地区儿童的学龄期结局，这些儿童从孕期到18个月龄接受了整群随机分组的水、环境卫生与个人卫生（WASH）和/或婴幼儿喂养（IYCF）干预措施。
环境卫生、个人卫生与婴儿营养功效（SHINE）试验于2012年至2015年招募了来自津巴布韦两个农村地区（奇鲁曼祖和舒鲁圭）的孕妇，并采用2×2析因设计将她们整群随机分组，分为标准治疗组、WASH组、IYCF组或WASH与IYCF联合组，共同主要结局为18个月龄时的年龄别身高Z评分和血红蛋白水平（clinicaltrials.govNCT01824940）。未感染艾滋病毒、7岁且仍居住在舒鲁圭地区的儿童符合这项随访研究的条件（在PACTR 202201828512110注册），并于2021年4月1日至2022年9月30日进行测量。7岁时的主要结局是使用考夫曼儿童评估量表（KABC-II）评估的认知功能。次要结局包括执行功能、读写和算术能力、精细运动技能、社会情感功能、握力、跳远距离、往返跑测试距离、人体测量、瘦体重指数和皮褶厚度。进行评估的研究护士对干预组不知情。分析遵循预先注册的统计分析计划。使用广义估计方程进行意向性分析，以评估WASH和IYCF对每个结局的长期影响，利用析因试验设计。还按儿童性别进行了预先指定的亚组分析。
在3989名艾滋病毒阴性女性中，3676名儿童在18个月龄时接受了评估；其中，1002名（510名女性）在平均（标准差）年龄7.3（0.2）岁时接受了评估。IYCF或WASH对KABC-II评分或次要认知结局没有影响，但WASH组的社会情感功能有小幅改善（-0.98分，95%置信区间-1.73，-0.22，p=0.01）。IYCF组的儿童握力更高（0.28千克，95%置信区间0.02，0.53，p=0.03）；然而，在预先指定的亚组分析中，仅在男孩中观察到握力改善（0.53千克，95%置信区间0.19，0.87，p=0.002）。两种干预措施对其他结局均无显著影响。
生命早期的IYCF和WASH在学龄期带来的功能益处很少。应考虑采用更全面、实施时间更长且包括关爱照护的干预措施，以改善长期认知和身体功能。
惠康基金会[220671/Z/20/Z，108065/Z/15/Z]；美国国立卫生研究院[R61HD103101]；思拉舍基金会[15250]；以及伊马纳基金会[3.02]。
