背景:儿童发育迟缓在许多低收入环境中仍然很常见,并且与发病率和死亡率增加有关,以及儿童发育受损。
方法:该研究的主要目的是评估家庭安装的生长图以及少量基于脂质的营养补充剂(SQ-LNS)是否可以减少婴儿的生长步履蹒跚。基线时2至10月龄婴儿的所有护理人员,在干预开始时至少6个月大,在Choma的282个随机选择的枚举区域中,赞比亚的曼萨和卢萨卡地区应邀参加了这项研究。集群随机化按地区分层。使用软件生成的随机数抽取将簇分配给四个组中的一个:(1)无干预(对照);(2)在家中安装挂图,其中包含生长监测工具以及有关婴幼儿喂养和营养的关键信息(仅生长图);(3)每月交付30袋SQ-LNS(仅SQ-LNS)或(4)生长图SQLNS。主要结果为儿童身高年龄z评分(HAZ)和18个月干预后发育迟缓(HAZ<-2)。次要结果是血红蛋白(Hb),贫血(Hb<110.0g/L),身高体重,年龄体重z评分(WAZ),体重不足(WAZ<-2)和儿童发育通过全球早期发育量表(GSED)测量。使用调整后的线性和逻辑回归模型分析结果,并将三种干预措施中的每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视而不见。
结果:在282个研究集群中,共有2291个照顾者-儿童二元组被纳入研究。将70个集群(557个二元组)分配到对照组,仅70个集群(643个二元)到增长图表,71个集群(525个二元组)到SQ-LNS,71个集群(566个二元组)到SQ-LNS和生长图。SQ-LNS将HAZ提高了0.21SD(95%CI0.06至0.36),并将发育迟缓的几率降低了37%(调整后的OR,OR0.63,95%CI(0.46至0.87))。仅在增长图或增长图+SQLNS臂中没有发现HAZ或发育迟缓的影响。SQ-LNS仅改进WAZ(平均差,MD0.17,95%CI(0.05至0.28)。生长图和综合干预对WAZ没有影响。仅在生长图(MD0.18,95%CI(0.01至0.35))和仅SQ-LNS臂(MD0.28,95%CI(0.09至0.46)中,儿童发育较高。SQ-LNS提高了平均血红蛋白水平(MD2.9g/L(0.2,5.5)。联合干预对WAZ没有影响,Hb或GSED但降低了贫血的几率(aOR0.72,95%CI(0.53至0.97))。未报告不良事件。
结论:SQ-LNS似乎在减少生长障碍以及改善贫血和儿童发育方面有效。生长图还显示了减少贫血和改善儿童发育的潜力,但似乎在解决生长迟缓方面没有那么有效。当两种干预措施相结合时,需要进一步的研究来更好地了解降低的有效性。
背景:NCT051204272。
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.
CONCLUSIONS: 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.
BACKGROUND: NCT051204272.