Multi-domain interventions from preconception to early childhood and neurodevelopment at 4-6 years
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
Dr Ravi Prakash Upadhyay
Society for Applied Studies
