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临床试验/NCT07259486
NCT07259486已完成不适用

Comparison of Outcomes of Early Kangaroo Mother Care and Standard Method Care in Healthy Low Birth Weight Preterm Neonates at a Tertiary Care Hospital

University of Health Sciences Lahore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Number of neonatal deaths within 72 hours after enrollment

研究概览

简要总结

The goal of this clinical trial is to learn whether early initiation of kangaroo mother care (KMC) can improve clinical outcomes in healthy low birth weight preterm neonates (gestational age 30-37 weeks, birth weight <2000 g). The study will be conducted among preterm infants admitted to the neonatal unit of Services Hospital Lahore.

The main questions it aims to answer are:

  • Does early kangaroo mother care initiated within the first 24 hours of birth improve neonatal outcomes compared with standard neonatal care?
  • Does early initiation of kangaroo mother care improve thermal stability, breastfeeding outcomes, and overall clinical recovery in low birth weight preterm infants?

Researchers will compare early kangaroo mother care with standard neonatal care to see if early initiation of skin-to-skin contact and breastfeeding support improves neonatal outcomes.

Participants will:

  • Be randomly assigned to receive either early kangaroo mother care or standard neonatal care.
  • Infants in the intervention group will receive early skin-to-skin contact with the mother or caregiver along with breastfeeding support according to hospital protocols.
  • Infants in the control group will receive standard neonatal care practices provided in the neonatal unit.

详细描述

Preterm birth remains the leading cause of mortality among children under five years of age worldwide. Each year approximately 15 million infants are born prematurely, accounting for more than one in ten births globally. Complications related to prematurity contribute substantially to neonatal mortality and long-term morbidity, particularly in low- and middle-income countries. Pakistan has one of the highest reported rates of preterm birth globally, highlighting the urgent need for effective, low-cost neonatal care strategies.

Low birth weight (LBW) preterm infants are particularly vulnerable to hypothermia, infection, feeding difficulties, and other complications due to physiologic immaturity. Conventional neonatal care for these infants often relies on incubators, radiant warmers, and specialized monitoring, which may be resource-intensive and difficult to sustain in high-volume public hospitals in low-resource settings.

Kangaroo Mother Care (KMC) is a cost-effective and evidence-based intervention designed to improve outcomes for preterm and LBW infants. The intervention consists primarily of continuous or intermittent skin-to-skin contact between the caregiver and infant, promotion of exclusive breastfeeding or breast-milk feeding, early discharge when clinically appropriate, and structured follow-up. Skin-to-skin contact helps maintain thermal stability, enhances breastfeeding success, and strengthens maternal-infant bonding. Previous studies and systematic reviews have demonstrated that KMC can reduce neonatal mortality, improve breastfeeding rates, and decrease the risk of severe infection and hypothermia in LBW infants.

Recent research has also explored the potential benefits of early initiation of KMC, including initiation soon after birth rather than after stabilization. The World Health Organization Immediate Kangaroo Mother Care study evaluated continuous KMC initiated shortly after birth in infants with birth weights between 1.0 and 1.799 kg and suggested potential survival benefits. However, further evidence is needed to determine the effectiveness of early KMC initiation in relatively stable LBW infants in routine clinical settings, particularly in low-resource environments.

This randomized controlled trial aims to evaluate the effectiveness of early initiation of kangaroo mother care within the first 24 hours after birth compared with standard neonatal care practices in healthy low birth weight preterm infants. Participants randomized to the intervention arm will receive structured early KMC with caregiver skin-to-skin contact and breastfeeding support according to institutional protocols. Infants in the control group will receive standard neonatal care as practiced in the neonatal unit.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Hour 至 24 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • New admission of singleton or twin (inborn or out-born)
  • Weight < 2000 g (as per study scale)
  • Age 1-24 h old when screening begins
  • Gestational age >30 weeks to <37 weeks
  • Mother or other caregiver available and willing to provide intervention

排除标准

  • Triplets who are all admitted to the study site
  • Congenital malformation not compatible with life or needing immediate surgical intervention
  • Severe jaundice
  • Stable as assessed during cardio-respiratory screening
  • Severely unstable as assessed during cardio-respiratory screening or died during screening
  • Severe perinatal asphyxia
  • Babies require a ventilator or inotropic support
  • The mother is critically ill or unable to comply with the follow-up schedule
  • No study bed available
  • Neonates/mothers enrolled in another research study
  • No written informed consent from parent or caregiver within 24 h of admission.

研究组 & 干预措施

Kangaroo Mother Care (Group-I)

Experimental

In the KMC group mothers were explained detail about KMC adoption in the presence of their family. KMC was initiated as soon as the baby was stable. If the mother is not available initially any of the family members can start KMC. The mother provided skin to skin contact in upright position dressed in a cap, socks, and diaper and supported in the bottom with a sling/binder. Adequate privacy was ensured. Comfortable chairs and beds were provided to the mothers practicing KMC in the nursery. Skin-to-skin contact was given for a minimum of 1 hour at a time and at least for 12 hrs./ day, duration was gradually increased to as long as comfortable to the mother and baby. When the baby is not in KMC, the baby was placed in the cot with adequately clothed and covered. A "KMC" chart was given to the mother to keep a record of the duration of kangaroo care provided. If the mother is unable to fill up the chart, it was done by a close family member.

干预措施: Kangaroo Mother Care (Other)

Standard Method Care (Group-II)

Active Comparator

Neonate in the SMC group was managed under a radiant warmer.

干预措施: Standard Medical Care (SMC) (Other)

结局指标

主要结局

Number of neonatal deaths within 72 hours after enrollment

时间窗: 0-72 hours of age

Vital status will be assessed every 12 hours during hospital stay. Neonatal death is defined as cessation of breathing and circulation confirmed by attending physician.

Number of neonatal deaths within 28 days of age

时间窗: Enrollment to Day 28

Vital status assessed every 12 hours during hospitalization and via home visit on Day 29.

Length of hospital stay from enrollment to discharge

时间窗: Enrollment to discharge

Total days spent in nursery/KMC ward from admission to discharge as documented in hospital records.

次要结局

  • Number of infants exclusively breastfed at 29 days of age(Day 29)
  • Number of infants with clinically suspected sepsis during hospital stay(Enrollment to discharge/Day 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Komal Khadim Hussain

Senior Medical Officer

University of Health Sciences Lahore

研究点 (1)

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