India Child Growth Standards Research Initiative: A Prospective Cohort Study to Develop Growth Standards in 0 to 24 months Indian Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 6
- 主要终点
- Growth standards for children from 0-24 months of age.
研究概览
简要总结
Healthy growth from conception through early life is crucial for laying a strong foundation for future physical health, work productivity, and cognitive capacity. Assessing children’s growth is crucial for evaluating the health and socioeconomic development of communities where they live. Currently, the most widely used standards for the assessment of growth and development of children are the World Health Organization growth standards based on the Multicenter Growth Reference Study (MGRS) conducted over 20 years ago. Since then, practices constituting an optimal environment for child growth have evolved. Also, the Indian data for WHO-MGRS study, collected from a single centre at South Delhi is not considered as representative of the Indian population by many critics. Therefore, a prospective cohort study with children from six regions of the country has been planned to measure childhood growth and development, from 0-24 months, in an environment without major biological, socio-behavioral, and economic constraints to growth. Other objectives of the study are to develop normative neurodevelopmental charts for Indian Children 0-24 months of age and growth curves for term Small for Gestational Age (SGA) babies from 0-24 months of age.
Pregnant women <37 weeks of gestation (with dating ultrasound available) will be screened to rule out major biological, socio-behavioral and economic constraints to growth of fetus. The term infants born of such eligible women, with no major congenital anomalies or birth complications, will be enrolled after taking informed, written consent from parent/s. A total of 300 boys and 300 girls will be enrolled from 6 sites. The enrolled infants will be followed every fortnightly from birth till 2 months, monthly till 12 months and then bimonthly till 24 months of age to record the anthropometric indices
such as weight, length, head circumference and mid upper arm circumference. Mothers/ care givers will be counselled on these visits about nurturing care framework that consists of good health, adequate nutrition, safety and security, responsive caregiving and opportunities for learning. WHO-GSED (Global Scale for Early Development- long and short forms) will be administered to all enrolled children to assess the development scores. The expected duration of the study is 3.5 years
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 24.00 Month(s)（—）
- 性别
- All
入选标准
- •Parental, Family and Environmental Criteria:
- •Spontaneously conceived term singleton birth with gestational age equal to or more than 37 completed weeks (259 days) and less than 42 completed weeks (294 days).
- •No significant illness diagnosed during pregnancy, such as severe anemia, pregnancy-induced hypertension, gestational diabetes mellitus, hypothyroidism, obesity, any chronic or severe medical illness.
- •No history of consumption of tobacco, alcohol, or other substance uses in any form during this pregnancy, and smoking inside the house by any family members.
- •15 years or more of formal parental education.
- •Family willing for frequent contacts.
- •Child characteristics:
- •Adequate adherence to criteria for a healthy growth environment including exclusive breastfeeding for 6 months, appropriate complementary feeding, and all the components of the nurturing care framework to ensure healthy caregiving environment.
- •Appropriate body composition.
排除标准
- •Congenital abnormalities that may affect growth such as congenital heart disease, neural tube defects based on antenatal USG or post-delivery clinical evaluation or any other major malformation.
- •Birth complications such as birth asphyxia, sepsis or any other morbidity that require longer hospital stay.
- •Any major illness diagnosed during the study period.
- •Major adverse environmental influences like child abuse.
- •Maternal death any time during the study period.
结局指标
主要结局
Growth standards for children from 0-24 months of age.
时间窗: Anthropometric data will be collected at Birth, 1-2,4,6,8 weeks of age and 3,4,5,6,7,8,9,10,11,12,14,16,18,20,22,24 months of age.
Weight for age (Z Score), Length for age (Z score), Weight for length (Z score), BMI for age and growth velocity charts will be developed
时间窗: Anthropometric data will be collected at Birth, 1-2,4,6,8 weeks of age and 3,4,5,6,7,8,9,10,11,12,14,16,18,20,22,24 months of age.
次要结局
- Neuro-developmental assessment will be done by WHO-GSED (Global Scale for Early Development).(Growth Charts for Small for Gestational Age babies (0-24 months) Weight for age (Z Score), Length for age (Z score), Weight for length (Z score), BMI for age & growth velocity charts will be developed)