跳至主要内容
临床试验/CTRI/2024/03/063820
CTRI/2024/03/063820尚未招募不适用

Multi-domain interventions from preconception to early childhood and neurodevelopment at 4-6 years

Society for Applied Studies1 个研究点 分布在 1 个国家目标入组 1,052 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,052
试验地点
1
主要终点
Cognition (IQ; intelligence quotient) and higher executive functions

研究概览

简要总结

Substantial number of under-5 children in low resource settings are documented to be at risk of developmental deficits. Even though it is established that the etiology is multi-factorial, previous studies have largely focused on standalone interventions delivered in specific phases of life i.e., either pregnancy or postnatal or a combination and found small to modest improvements on child neurodevelopment. Effects of additional intervening in the period prior to conception (pre-conception period) are largely unstudied and so is the impact of a package of interventions that address majority of the modifiable risk factors for poor development. Our recent trial (WINGS) (CTRI/2017/06/008908) showed that a package of health, nutrition, psychosocial care, and WaSH interventions encompassing preconception, pregnancy and early childhood periods leads to substantial improvement in neurodevelopmental outcomes at 24 months of age (https://pubmed.ncbi.nlm.nih.gov/38165408/).

The present study will follow up children, enrolled in the previously conducted WINGS trial, until their pre-school age (4-6 years) and assess their neurodevelopment.

研究设计

研究类型
Observational

入排标准

年龄范围
4.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Children who participated in primary trial(CTRI/2017/06/008908) and whose families consent to participate in the follow up study.

排除标准

  • Non-consent to participate in the follow up study.
  • Those with severe illness requiring prolonged hospital admission.
  • Those with documented neuro-psychological ailment(s).
  • Those with documented visual problems (for eye-tracking assessments).

结局指标

主要结局

Cognition (IQ; intelligence quotient) and higher executive functions

时间窗: At 4 to 6 years of completed age

次要结局

  • School readiness(At 4 to 6 years of completed age)
  • Language performance(At 4 to 6 years of completed age)
  • Psychosocial and emotional behavior(At 4 to 6 years of completed age)
  • Visual working memory and attention (using eye tracking based assessment)(At 4 to 6 years of completed age)
  • Quality of stimulation and learning opportunities at home(At 4 to 6 years of completed age)

研究者

申办方类型
Other [Not for profit research organization]
责任方
Principal Investigator
主要研究者

Dr Ravi Prakash Upadhyay

Society for Applied Studies

研究点 (1)

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