跳至主要内容
临床试验/NCT06559020
NCT06559020已完成不适用

Predictors for Opting for Kangaroo Mother Care in Pakistan and Infant Development Outcomes Based on a Quasi-Experimental Intervention

Services Institute of Medical Sciences, Pakistan2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Number of babies Holding head up

研究概览

简要总结

This quasi-experimental study evaluated the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on the growth, developmental milestones, breastfeeding, vaccination, and mortality of low birth weight infants in Services Hospital Lahore, Pakistan. A total of 400 infants were enrolled and followed for one year.

详细描述

This quasi-experimental study was conducted in the Obstetrics and Gynecology Department of Services Institute of Medical Sciences (SIMS), Lahore, Pakistan, to compare the impact of Kangaroo Mother Care (KMC) versus Conventional Care (CC) on low birth weight infants. A total of 400 infants (200 in each group) born between January 2020 and December 2022 were included in the study, with participants selected based on specific inclusion criteria and informed consent obtained. KMC involved continuous skin-to-skin contact between mother and infant during the hospital stay and continued at home for at least 8 hours daily. The follow-up schedule included appointments at six weeks after birth, monthly visits until six months of age, and quarterly visits until the infants reached one year of age. During these visits, the study collected data on infant growth, developmental milestones, breastfeeding practices, and vaccination status. The study was ethically approved by the research ethics committee, and data collection was conducted during scheduled follow-up visits to the outpatient department.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • women who were able to follow the program instructions,
  • permanent residents of Lahore and its periphery and willing to be part of program for the one-year time period,
  • live newborn babies delivered either vaginally or through caesarean section with birth weight of 1.5 to 2 kg,
  • gestational age between 28 to 36 weeks.

排除标准

  • an infant or mother diagnosed with a life-threatening ailment, major disease, or major malformations,
  • early-detected major conditions arising from perinatal problems, such as severe hypoxic-ischemic encephalopathy, pulmonary hypertension,
  • incidence of severe infection measured as nosocomial infections requiring systemic antibiotics or infections, severe respiratory distress, and hypothermia episodes (temperature less than 35C).

结局指标

主要结局

Number of babies Holding head up

时间窗: 3 months

baby able to hold their head up

Number of babies crawling

时间窗: 10 months

baby able to move forward on hands and knees

average length of infant

时间窗: 1 year

Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year

Average head circumference of infant

时间窗: 1 year

Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year

Number of babies produce 2 syllable sounds

时间窗: 9 months

baby able to produce words that have two definite sounds

Duration of Breastfeeding

时间窗: from 2 hours to 1 year

breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year

Number of babies with complete vaccination

时间窗: 1 year

infant receiving all scheduled vaccinations within their first year of life

Number of babies Sitting without support

时间窗: 6 months

Baby gets into sitting position without help

Number of babies roll over

时间窗: 8 months

baby able to roll from side to side

Number of babies babbles

时间窗: 6 months

baby able to produce repititive incomprehensible sounds

cumulative Mortality rate

时间窗: 1 year

Death of baby

Average weight of baby

时间窗: 1 year

Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year

次要结局

  • Number of babies with Hypothermia(72 hours)
  • Number of babies with Sepsis(72 hours)

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tayyiba Wasim

Professor Obstetrics & Gynaecology

Services Institute of Medical Sciences, Pakistan

研究点 (2)

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