Low-birthweight Infant Feeding Exploration 24-Month Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 597
- 试验地点
- 3
- 主要终点
- Growth trajectories from 12 to 24 months of age
研究概览
简要总结
The overall studygoal is to understand feeding options for LBW infants in LMIC settings up to 24months of age, including current feeding practices, child development, healthand growth outcomes and potential interventions. The study will take place in twocountries: Tanzania and India. Each country will encompass 3 to 5 individualstudy facilities. This study is an extension of the research projecttitled LIFE Extension: Low-birthweight Infant Feeding Exploration Extension whichis previously registered in CTRI (CTRI No: CTRI/2020/06/026004). It willfill a critical data gap in the field of new born care regarding feeding LBWinfants. We aim to establish the background information required to set up andtest the most efficient and feasible infant feeding strategies for LBW infants:to support infants who are nutritionally at risk in the first 24 months of lifein LMICs. We will explore all three infant feeding options currently includedin the WHO guidelines for LBW infants (WHO 2011), namely mother’s own milk(MOM), donor human milk (DHM), and breast milk substitute or formula (BMS), inthat order. This work will provide much-needed evidence to inform infantfeeding guidelines. Specifically, we will be able to describe thefollowing for these LBW infants: 1. Duration of time fed breastmilk and whenstopped 2. Maternal depression 3. Morbidity and care-seeking 4. Cognitive and motor development and family care indicators 5. Vital status (maternal and infant death and withdrawals) This study will allow for a more comprehensive exploration andunderstanding of feeding options for LBW infants from 12 to 24 months of age,changes in feeding types, growth and health outcomes over the entire infancyperiod. This will contribute significantly and allow for high quality data todescribe the burden of disease across sites.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Mother/ Infant pair are
- •Currently enrolled in the LIFE study and extension (follow-up from birth to 1 year of age) and fulfills all original inclusion criteria (infant birthweight between 1500g and <2500g, residence in catchment area of facilities in which born)
- •Mothers consent obtained for herself and infant for another 12 month of follow up
- •That the mother /child (dyad) did not withdraw or the baby did not die.
排除标准
- •Mother/ Infant pairs
- •Not previously enrolled in the LIFE study in addition to all original exclusion criteria (birthweight outside range, congenital abnormalities at birth, neonatal encephalopathy at birth, young mother, maternal death during labor and delivery, infant death before 72 hours of life, infant is more than 72 hours old at enrollment).
结局指标
主要结局
Growth trajectories from 12 to 24 months of age
时间窗: 12 to 24 months of age
次要结局
- Understand the relationship between infant growth at 24 months and child development at 24 months(Up to 24 months of age)
- Examine the predictors (Ex: duration of breast feeding, maternal depression, hospitalizations, demographics etc.) of infant growth (WAZ/LAZ/WLZ) at 24 months(Up to 24 months of age)
- Examine the predictors (Ex: duration of breastfeeding, maternal depression, family care indicators, demographics etc.) of child development at 24 months(Up to 24 months of age)