Efficacy of Early Skin-to-Skin Contact on Rate of Exclusive Breastfeeding at 6 weeks of age in Healthy Term Neonates born by Vaginal Delivery: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary outcome of the study was efficacy of early skin to skin contact on rate of exclusive breastfeeding at 6 weeks of postnatal age.
研究概览
简要总结
This prospective, open label, randomized controlled trial was conducted at a teaching hospital in north India to evaluate efficacy of early and brief skin to skin contact on the rate of exclusive breastfeeding at 6 weeks of age . Early initiation of breastfeeding has been shown to reduce neonatal mortality by one-fourth. However, in India only about one-fourth neonates get first breastfeeding within one hour of birth and less than half are exclusive breastfed at six months of age. In addition to providing warmth, it facilitates attachment to the breast and improves bonding/attachment. Early Skin to Skin to contact, placing of the naked baby prone on the mother’s bare chest soon after the birth has been has been recommended as an important component of the care immediately after birth and is included as a requirement in World Health Organisation/ United Nations children’s fund (WHO/UNICEF) Baby Friendly Hospital Initiative (BFHI). Extended and uninterrupted early mother-infant contact after birth has been identified as a factor influencing effective sucking at the breast.
In a systematic review, early Skin to Skin Contact was observed to increase rate of exclusive breastfeeding and breastfeeding duration. However, need of further studies was highlighted in the view of poor methodological quality of previous clinical trials and heterogeneity in reported outcomes. We planned this study to evaluate efficacy of early and brief skin to skin contact on rate of exclusive breastfeeding at 6 weeks of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates born at term gestation by vaginal delivery and not requiring initial steps as per Neonatal Resuscitation Algorithm of American Academy of Pediatrics-American Heart Association.
排除标准
- •Neonates with major congenital malformations, product of multiple pregnancies, known HIV-seropositive mother, any contraindication for breastfeeding and inability to come for follow up at 6 weeks.
结局指标
主要结局
Primary outcome of the study was efficacy of early skin to skin contact on rate of exclusive breastfeeding at 6 weeks of postnatal age.
时间窗: Primary outcome of the study was efficacy of early skin to skin contact on rate of exclusive breastfeeding estimated at 6 weeks of postnatal age.
次要结局
- effect of early skin to skin contact on the maternal pain during episiotomy repair(within 45 minutes of birth of neonate)