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家庭安装生长图表和小剂量基于脂质的营养补充剂(SQ-LNS)对赞比亚儿童生长的影响:一项四臂平行开放标签群组随机对照试验。

The impact of home-installed growth charts and small-quantity lipid-based nutrient supplements (SQ-LNS) on child growth in Zambia: a four-arm parallel open-label cluster randomised controlled trial.

机构信息

University of Basel, Basel, Switzerland

Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.

出版信息

BMJ Glob Health. 2024 Aug 16;9(8):e015438. doi: 10.1136/bmjgh-2024-015438.

Abstract

BACKGROUND

Childhood stunting remains common in many low-income settings and is associated with increased morbidity and mortality, as well as impaired child development.

METHODS

The main objective of the study was to assess whether home-installed growth charts as well as small-quantity lipid-based nutrient supplements (SQ-LNS) can reduce growth faltering among infants. All caregivers of infants between 2 and 10 months of age at baseline, and at least 6 months old at the beginning of the interventions, in 282 randomly selected enumeration areas in Choma, Mansa and Lusaka districts in Zambia were invited to participate in the study. Cluster randomisation was stratified by district. A software-generated random number draw was used to assign clusters to one of four arms: (1) no intervention (control); (2) home installation of a wall chart that contained a growth monitoring tool along with key messages on infant and young child feeding and nutrition (growth charts only); (3) 30 sachets of SQ-LNS delivered each month (SQ-LNS only) or (4) growth charts+SQ LNS. The primary outcomes were children's height-for-age z-score (HAZ) and stunting (HAZ <-2) after 18 months of intervention. Secondary outcomes were haemoglobin (Hb), anaemia (Hb<110.0 g/L), weight-for-height, weight-for-age z-score (WAZ), underweight (WAZ<-2) and child development measured by the Global Scales of Early Development (GSED). Outcomes were analysed intention to treat using adjusted linear and logistic regression models and compared each of the three interventions to the control group. Assessors and analysts were blinded to the treatment-blinding of participating families was not possible.

RESULTS

A total of 2291 caregiver-child dyads across the 282 study clusters were included in the study. 70 clusters (557 dyads) were assigned to the control group, 70 clusters (643 dyads) to growth charts only, 71 clusters (525 dyads) to SQ-LNS and 71 clusters (566 dyads) to SQ-LNS and growth charts. SQ-LNS improved HAZ by 0.21 SD (95% CI 0.06 to 0.36) and reduced the odds of stunting by 37% (adjusted OR, aOR 0.63, 95% CI (0.46 to 0.87)). No HAZ or stunting impacts were found in the growth charts only or growth charts+SQ LNS arms. SQ-LNS only improved WAZ (mean difference, MD 0.17, 95% CI (0.05 to 0.28). No impacts on WAZ were seen for growth charts and the combined intervention. Child development was higher in the growth charts only (MD 0.18, 95% CI (0.01 to 0.35)) and SQ-LNS only arms (MD 0.28, 95% CI (0.09 to 0.46). SQ-LNS improved average haemoglobin levels (MD 2.9 g/L (0.2, 5.5). The combined intervention did not have an impact on WAZ, Hb or GSED but reduced the odds of anaemia (aOR 0.72, 95% CI (0.53 to 0.97)). No adverse events were reported.

INTERPRETATION

SQ-LNS appears to be effective in reducing growth faltering as well as improving anaemia and child development. Growth charts also show the potential to reduce anaemia and improve child development but do not seem as effective in addressing growth faltering. Further research is needed to better understand reduced effectiveness when both interventions are combined.

TRIAL REGISTRATION NUMBER

NCT051204272.

摘要

背景

在许多低收入环境中,儿童发育迟缓仍然很常见,与发病率和死亡率增加以及儿童发育受损有关。

方法

本研究的主要目的是评估家庭安装生长图表以及小剂量脂质基营养补充剂(SQ-LNS)是否可以减少婴儿的生长迟缓。在赞比亚乔马、曼萨和卢萨卡地区的 282 个随机选择的普查区中,所有在基线时年龄在 2 至 10 个月之间且在干预开始时至少 6 个月大的婴儿的看护人都被邀请参加研究。按区进行分层聚类随机化。使用软件生成的随机数抽取来将集群分配到四个组之一:(1)无干预(对照组);(2)家庭安装包含生长监测工具以及婴儿和幼儿喂养和营养关键信息的墙壁图表(仅生长图表);(3)每月提供 30 包 SQ-LNS(仅 SQ-LNS)或(4)生长图表+SQ-LNS。主要结果是干预后 18 个月儿童的身高年龄 Z 分数(HAZ)和发育迟缓(HAZ <-2)。次要结果是血红蛋白(Hb)、贫血(Hb<110.0 g/L)、身高体重比、体重年龄 Z 分数(WAZ)、体重不足(WAZ <-2)和儿童发展由全球早期发展量表(GSED)衡量。使用调整后的线性和逻辑回归模型对意向治疗进行分析,并将每三种干预措施与对照组进行比较。评估人员和分析人员对参与家庭的治疗盲法不了解。

结果

在 282 个研究集群中,共有 2291 对看护人-儿童进行了研究。70 个集群(557 对)被分配到对照组,70 个集群(643 对)到生长图表组,71 个集群(525 对)到 SQ-LNS 组,71 个集群(566 对)到 SQ-LNS 和生长图表组。SQ-LNS 将 HAZ 提高了 0.21 SD(95%CI 0.06 至 0.36),并将发育迟缓的几率降低了 37%(调整后的 OR,aOR 0.63,95%CI(0.46 至 0.87))。在仅生长图表或生长图表+SQ-LNS 组中,没有发现 HAZ 或发育迟缓的影响。仅 SQ-LNS 提高了 WAZ(平均差异,MD 0.17,95%CI(0.05 至 0.28)。生长图表和联合干预对 WAZ 没有影响。仅生长图表(MD 0.18,95%CI(0.01 至 0.35))和仅 SQ-LNS 组(MD 0.28,95%CI(0.09 至 0.46))的儿童发育较高。SQ-LNS 提高了平均血红蛋白水平(MD 2.9 g/L(0.2,5.5)。联合干预对 WAZ、Hb 或 GSED 没有影响,但降低了贫血的几率(aOR 0.72,95%CI(0.53 至 0.97))。没有报告不良事件。

解释

SQ-LNS 似乎可以有效减少生长迟缓,改善贫血和儿童发育。生长图表也显示出减少贫血和改善儿童发育的潜力,但在解决生长迟缓方面似乎效果不佳。需要进一步研究以更好地了解当两种干预措施结合使用时效果降低的原因。

试验注册编号

NCT051204272。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2611/11331861/44edcb70e9c6/bmjgh-9-8-g001.jpg

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