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临床试验/CTRI/2025/08/093339
CTRI/2025/08/093339尚未招募不适用

Impact of Integrated Interventions in the Next 1000 days to Promote Optimum Growth, Neurodevelopment and Metabolic Health in Small and Vulnerable Children (SAMPOORNA)

Sunita Taneja1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2025年9月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,600
试验地点
1
主要终点
Linear Growth: Height-for-age z-score (HAZ)

研究概览

简要总结

Small and vulnerable newborns (SVNs) represent a significant public health concern, particularly in South Asia, which accounts for 63% of global term SGA births and has a preterm birth prevalence of 13.2%. These infants are at increased risk for stunted growth, cognitive delays, and metabolic disorders. Although interventions during the first 24 months of life have demonstrated some benefits, there is a notable lack of sustained improvements in growth, neurodevelopment, and metabolic health as SVNs transition into early childhood. This gap underscores the urgent need for research and innovation targeting the next 1,000 days (ages 2 to 5 years), a critical but underexplored period for long-term child health.

Hence a randomized controlled factorial trial is designed to evaluate the impact of an integrated package of interventions including optimized nutrition, developmental stimulation, and maternal support delivered from age 2 to 5 years to children born preterm or term SGA. Eligible children from an established cohort will be re-randomized at 24 months and followed through 5 years of age, with outcomes assessed for growth (height-for-age z-score), cognitive development, and metabolic health. The trial aims to generate high-quality evidence on scalable, multi-domain interventions to improve growth, neurodevelopment, and metabolic outcomes in SVNs. Results will inform future child health policies and programs and address a critical knowledge gap in the care of this high-risk group.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Participant in either intervention or control group of the Small Babies Trial Child aged 24 months (±29 days) at enrollment Family intends to remain in study area for next 3 years Written informed consent from parent/caregiver.

排除标准

  • Any chronic diagnosed condition which impairs growth Diagnosed and documented neurodevelopmental impairment currently receiving specialized therapy.

结局指标

主要结局

Linear Growth: Height-for-age z-score (HAZ)

时间窗: 5 years | 5 years

Neurodevelopment: IQ, Executive function, School readiness assessed using standardized tools

时间窗: 5 years | 5 years

次要结局

  • Metabolic Health: Biomarkers (HOMA-IR, lipid profile, HbA1c, CRP, IL-6, adiponectin, leptin. Haemoglobin(5 years)
  • Anthropometry (Wt, ht; head, waist – circumference, MUAC)(Every 6 months starting from 2 years)
  • Morbidity & care-seeking(Every 6 months starting from 2 years)
  • Dietary intake/diversity (subsample)(Baseline, 3, 4 & 5 years)
  • Parental Empowerment(Baseline and 5 years)
  • Body Composition (DXA)(5 years)
  • Non-alcoholic fatty liver disease: Abdominal ultrasound(5 years)
  • Physical activity(Baseline, 5 years)

研究者

发起方
Sunita Taneja
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sunita Taneja

Society for Applied Studies

研究点 (1)

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