Effects of Kangaroo Mother Care Among LBW and Preterm Infants:A Randomized Control Trial in Karachi
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Breastfeeding outcomes
研究概览
简要总结
- Hypothermia, infections ,and ineffective breastfeeding are some of the commonest causes of deaths among premature and low birth weight LBW infants. Even if the infants are born in facilities, incidences of cold stress are possible due to insufficient resources, space and incompetent practices to manage hypothermia in the immediate postnatal period. Kangaroo Mother Care is a well-known intervention to address the issues related to preterm births, such as hypothermia, infection and prolong hospitalization.Besides significant outcome of KMC interventions for preterm infants, no interventional study has been found in literature in Pakistani context. Looking at the potential benefits of KMC in reducing the related complications of prematurity, the study aims to identify the effectiveness of KMC among preterm and LBW infants born in secondary hospital of Aga khan University hospitals.
Hypothesis I Ha: KMC is effective in reducing the incidences of hypothermia among preterm and LBW infants as compared to the usual care.
Hypothesis II Ha: There is a difference in breastfeeding behavior and breastfeeding outcome among experimental and control group.
Secondary Hypothesis Hypothesis I Ha: There is an association between KMC and frequency of suspected infections during hospitalization.
Hypothesis II Ha: There is a difference in length of stay among experimental group and control group.
Hypothesis III Ha: There is a relationship between KMC and weight gain of infants till four weeks.
Hypothesis IV Ha: There is difference in rate of hypothermia among experimental group and control after discharge from hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any preterm neonates (< 37 weeks of gestation by maternal dates)
- •Low birth weight infants less than 2500 gm.
排除标准
- •Infants with brain hemorrhage, congenital abnormalities.
- •Infants needed double phototherapy.
- •Exclusion of Mother:
- •Mothers with severe depression, sickness with intensive care requirements. Mother who refused to participate. Mothers who delivered live multiple babies.
研究组 & 干预措施
Kangaroo Mother Care
Other than routine clinical care per hospital policy. Infants will receive skin-to-skin contact for minimum one hour daily during hospital stay and at home till one month.
干预措施: Kangaroo Mother Care (Behavioral)
Standard Care
Routine incubator or cot care with breastfeeding support from nurses as per policy.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
Breastfeeding outcomes
时间窗: 30 days
Comparison of breastfeeding frequency per day, method of feeding. (partial/ exclusive)in hospital and at home. Breastfeeding behaviour by using preterm Infants breastfeeding behaviour Scale(PIBBS). Follow-up till one months by calling and record keeping of breastfeeding status.
次要结局
- Rate of Infection(1-2 weeks(During hospital stay))
- weight gain(30 days)
- length of stay(1-2 weeks)
研究者
Ms Seema Hyderali
Student
Aga Khan University