Effect of Early Skin to Skin Contact on Breast Feeding Behaviour in Term Newborns: 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
- 41
- 试验地点
- 2
- 主要终点
- The Median Breast Feeding Score
研究概览
简要总结
Aims and Objectives
Aim
To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of term neonates born by normal vaginal delivery at 36-48 hours.
Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48 hours (as measured by Infant Breast Feeding Score) by video recording using a randomized controlled design.
Secondary objectives To determine the effect of delivery room Skin to Skin contact on
- Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA)
- Weight at 48 hours as measured by digital infant weighing scale.
- Maternal perception of breast milk output, breast consistency, infant's feeding and activity at 36-48 hours as measured by a score graded as very satisfied, satisfied, acceptable and not satisfied.
- Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours
- Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit to the hospital for the same or as asked by telephonic conversation.
Hypothesis
Infants receiving skin to skin contact when compared with neonates not receiving it, demonstrate better breast feeding behaviour.
详细描述
Inclusion and exclusion criteria for the enrollment of subjects in the study
Inclusion criteria Term babies born to mothers by normal vaginal delivery in the study period.
Exclusion criteria
- Babies with major congenital malformation.
- Multiple pregnancy
- Babies requiring resuscitation beyond the initial steps
- Babies requiring care in the neonatal intensive care unit.
- Maternal problems requiring immediate care
- Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
- Imminent eclampsia
- Severe bleeding
- Mother with significant surgical or medical illness requiring separation of the baby from the mother.
- Small for dates and large for dates babies
- Infants of diabetic mother
- Maternal refusal of consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term babies born to mothers by normal vaginal delivery in the study period.
排除标准
- •Babies with major congenital malformation.
- •Multiple pregnancy
- •Babies requiring resuscitation beyond the initial steps
- •Babies requiring care in the neonatal intensive care unit.
- •Maternal problems requiring immediate care
- •Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain
- •Imminent eclampsia
- •Severe bleeding
- •Mother with significant surgical or medical illness requiring separation of the baby from the mother.
- •Small for dates and large for dates babies
- •Infants of diabetic mother
- •Maternal refusal of consent.
结局指标
主要结局
The Median Breast Feeding Score
时间窗: 36-48 hours by video recording
This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure \[0 to 3\] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more \>=8.
次要结局
- Breast Feeding Status at 48 Hours(48 hours)
- Salivary Cortisol(6 hours)
- Breast Feeding Status at 6 Weeks(6 weeks)
研究者
Anu Thukral
Doctor
All India Institute of Medical Sciences, New Delhi