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临床试验/CTRI/2024/12/077916
CTRI/2024/12/077916招募中不适用

Impact of an integrated health, nutrition and early child stimulation intervention package delivered to preterm and small for gestational babies during infancy, on body composition

Dr Ranadip Chowdhury1 个研究点 分布在 1 个国家目标入组 1,048 人开始时间: 2025年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,048
试验地点
1
主要终点
Mean Attained Lean mass

研究概览

简要总结

Preterm and small for gestational age (SGA) infants represent a significant public health concern, particularly in South Asia, where they account for nearly 41% of live births. These infants face dual risks of excess fat gain and poor skeletal development, increasing their susceptibility to adult non-communicable diseases (NCDs) through metabolic programming. Current evidence suggests these risks stem from suboptimal growth trajectories and early-life nutritional deficiencies. While interventions targeting body composition have shown some promise, evidence on comprehensive approaches is sparse, particularly in low- and middle-income settings.

This study, embedded in an ongoing RCT (pubmed.ncbi.nlm.nih.gov/38331842/), seeks to assess the impact of integrated health, nutrition, and early child stimulation interventions on body composition at 12 months of age. Interventions include breastfeeding support, growth monitoring, nutritional supplementation with a milk cereal mix, and early child stimulation activities. Using a fan-beam Dual-energy X-ray Absorptiometry (DXA) with infant-adapted Lunar software, it will measure lean mass, fat mass, and bone mineral density (BMD). The findings aim to optimize growth interventions for preterm and SGA infants, informing policies to mitigate the dual burden of malnutrition and NCD risk in vulnerable populations.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
12.00 Month(s) 至 13.00 Month(s)(—)
性别
All

入选标准

  • Children participating in Small Babies Trial
  • Completed 12 months of age.

排除标准

  • Non-Consent
  • Not Available at the time of assessment.

结局指标

主要结局

Mean Attained Lean mass

时间窗: 12 months of age

次要结局

  • Bone mineral density (g/cm²)(12 months of age)
  • Regional fat distribution(12 months of age)
  • Differential effect on body composition in preterm SGA, term SGA, and preterm AGA infants(12 months of age)
  • Fat mass (g)(12 months of age)

研究者

发起方
Dr Ranadip Chowdhury
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ranadip Chowdhury

Society for Applied Studies

研究点 (1)

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