Effect of community initiated kangaroo mother care in low birth weight infants on linear growth, infection reduction, breast milk properties and related biological outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,600
- 试验地点
- 1
- 主要终点
- 1. LAZ score (4600 sample size)
研究概览
简要总结
Kangaroo Mother Care (KMC) is a unique intervention shown to promote survival in low birth weight infants in health facilities, but the underlying pathways are unclear. To study impact of community initiated KMC, investigators from Society for Applied Studies are conducting a trial on the same with the primary outcome as neonatal mortality titled “Effect of Community Initiated Kangaroo mother care on babies with Low Birth Weightâ€. This trial provides an opportunity to add mechanistic outcomes to explain underlying pathways. We propose to embed within the large intervention trial, a sub-study, which will assess impact of KMC in LBW infants on linear growth, possible serious bacterial infection, infant breast milk intake and breast milk quality, maternal stress reduction, infant skin maturity and gut microbiome. Linking this mechanistic sub-study to explain pathways is an innovative way to add value to the public health trial to fill some critical knowledge gaps and provide evidence whether KMC can promote linear growth and reduce infections which are key to survival of LBW babies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 4.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Singleton Low birth weight babies (≥1500 to ≤2250 g) included in the trial titled “Effect of Community Initiated Kangaroo mother care on babies with Low Birth Weight†who are either born at home or hospital but KMC not initiated in the hospital.
排除标准
- •1.Infant unable to feed 2.Infant has breathing problem or is less active 3.Twins or triplets 4.Gross congenital malformations 5.Mother does not intend to stay in the study area for the next 6 months.
结局指标
主要结局
1. LAZ score (4600 sample size)
时间窗: End of neonatal period
2. Postpartum depressive symptoms (1950 sample size)
时间窗: End of neonatal period
次要结局
- Breastfeeding performance: successful breastfeeding, lactation failure and use of breast milk substitutes (in a sub sample)(at the end of neonatal period)
- Maternal stress and cortisol levels(sub sample of 550)(at the end of neonatal period)
- Gut inflammatory markers: Fecal Calprotectin, Myeloperoxidase, alpha1antitrypsin(in a sub sample)(at the end of neonatal period)
- Relative abundance of and diversity of infant gut microbiome (in a sub sample)(at the end of neonatal period)
- Breast milk antimicrobial proteins(in a sub sample)(3rd week of life)
- Infant breast milk intake during the neonatal period (sub sample of 550 infants)(neonatal period)
- LAZ and WHZ score(3 and 6 months)