一项针对发育迟缓儿童的个性化辅食喂养干预的发育结局：危地马拉一项大型随机对照试验的子研究。
Developmental outcomes of an individualised complementary feeding intervention for stunted children: a substudy from a larger randomised controlled trial in Guatemala.
作者信息
Martinez Boris, Cardona Sayra, Rodas Patricia, Lubina Meri, Gonzalez Ana, Farley Webb Meghan, Grazioso Maria Del Pilar, Rohloff Peter
机构信息
Wuqu' Kawoq, Maya Health Alliance, Santiago Sacatepéquez, Guatemala.
Department of Medicine, Saint Peter's University Hospital, New Brunswick, New Jersey, USA.
出版信息
BMJ Paediatr Open. 2018 Oct 3;2(1):e000314. doi: 10.1136/bmjpo-2018-000314. eCollection 2018.
OBJECTIVE
Stunting is a common cause of early child developmental delay; Guatemala has the fourth highest rate of stunting globally. The goal of this study was to examine the impact of an intensive community health worker-led complementary feeding intervention on early child development in Guatemala. We hypothesised that the intervention would improve child development over usual care.
DESIGN
A substudy from a larger individually randomised (1:1 allocation ratio), parallel-group superiority trial, with blinding of study staff collecting outcomes data.
SETTING
Rural, indigenous Maya communities in Guatemala.
PARTICIPANTS
210 stunted children (height-for-age z-score ≤-2.5) aged 6-24 months, previously randomised to usual care (106) or an intensive complementary feeding intervention (104). 84 in the intervention and 91 in the usual care arm agreed to participate.
INTERVENTIONS
Community health workers conducted monthly home visits for 6 months, providing usual care or individualised complementary feeding education.
MAIN OUTCOME MEASURES
The primary outcomes were change in z-scores for the subscales of the Bayley Scales of Infant Development (BSID), Third Edition.
RESULTS
100 individuals were included in the final analysis, 47 in the intervention and 53 in the usual care arm. No statistically significant differences in age-adjusted scores between the arms were observed for any subscale. However, improvements within-subjects in both arms were observed (median duration between measurements 189 days (IQR 182-189)). Mean change for subscales was 0.45 (95% CI 0.23 to 0.67) z-scores in the intervention, and 0.43 (95% CI 0.25 to 0.61) in the usual care arm.
CONCLUSIONS
An intensive complementary feeding intervention did not significantly improve developmental outcomes more than usual care in stunted, indigenous Guatemalan children. However, both interventions had significant positive impacts on developmental outcomes.
TRIAL REGISTRATION NUMBER
NCT02509936.
STAGE
Results.
目的
发育迟缓是幼儿早期发育延迟的常见原因；危地马拉的发育迟缓率在全球排名第四。本研究的目的是检验由社区卫生工作者主导的强化辅食干预对危地马拉幼儿早期发育的影响。我们假设该干预措施相较于常规护理能改善儿童发育情况。
设计
一项来自规模更大的个体随机（1:1分配比例）平行组优势试验的子研究，收集结果数据的研究人员对研究进行了盲法处理。
地点
危地马拉农村的玛雅原住民社区。
参与者
210名发育迟缓儿童（年龄别身高z评分≤ -2.5），年龄在6至24个月之间，之前被随机分配到常规护理组（106名）或强化辅食干预组（104名）。干预组84名和常规护理组91名同意参与。
干预措施
社区卫生工作者每月进行一次为期6个月的家访，提供常规护理或个性化的辅食喂养教育。
主要结局指标
主要结局指标是贝利婴幼儿发展量表第三版（BSID）各分量表z评分的变化。
结果
100人纳入最终分析，干预组47人，常规护理组53人。两组在任何分量表上的年龄校正分数均未观察到统计学上的显著差异。然而，两组内均观察到受试者有所改善（两次测量之间的中位时长为189天（四分位间距182 - 189））。干预组分量表的平均变化为0.45（95%置信区间0.23至0.67）z评分，常规护理组为0.43（95%置信区间0.25至0.61）。
结论
在危地马拉发育迟缓的原住民儿童中，强化辅食干预相较于常规护理并未显著改善发育结局。然而，两种干预措施对发育结局均有显著的积极影响。
试验注册号
NCT02509936。
阶段
结果。
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