Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Low Birth Weight Infants
• Intervention / Treatment: Behavioral: Kangroo mother care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kangroo mother care; he KMC group will receive continuous skin-to-skin contact between mother and infant for 24 hours a day, with support and training in kangaroo positioning and exclusive breastfeeding.	Behavioral: Kangroo mother care; Kangaroo Mother Care (KMC) involves continuous skin-to-skin contact between the mother (or another family member) and the infant, aimed at promoting thermal regulation, breastfeeding, and bonding. In this study, KMC was initiated in the hospital and continued at home for a minimum of 8 hours daily.
No Intervention: conventional care; The control group will receive conventional neonatal care, which includes placing newborns in open cots with appropriate heating or cooling based on weather conditions. Mothers will receive guidance on the benefits of exclusive breastfeeding and support to initiate breastfeeding, but will not have the structured kangaroo mother care provided to the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Breastfeeding	breastfeeding initiation within 2 hours, exclusive breastfeeding for 6 months, breastfeeding up to one year	from 2 hours to 1 year
Number of babies with complete vaccination	infant receiving all scheduled vaccinations within their first year of life	1 year
Average weight of baby	Weight of infant in Kg at birth, 6 weeks, 1 year, 6 months, and 1 year	1 year
average length of infant	Length of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year	1 year
Average head circumference of infant	Head circumference of infant in cms at birth, 6 weeks, 1 year, 6 months, and 1 year	1 year
Number of babies Holding head up	baby able to hold their head up	3 months
Number of babies Sitting without support	Baby gets into sitting position without help	6 months
Number of babies roll over	baby able to roll from side to side	8 months
Number of babies crawling	baby able to move forward on hands and knees	10 months
Number of babies babbles	baby able to produce repititive incomprehensible sounds	6 months
Number of babies produce 2 syllable sounds	baby able to produce words that have two definite sounds	9 months
cumulative Mortality rate	Death of baby	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of babies with Hypothermia	core body temperature less than 35 degree celsius	72 hours
Number of babies with Sepsis	infection leading to life threatening inflammatory response	72 hours

Collaborators and Investigators

• Sponsor: Services Institute of Medical Sciences, Pakistan
• Investigators: Principal Investigator: Tayyiba Wasim, FCPS, Services Institute of Medical Sciences, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Vaccination; Breast feeding; Pakistan; Neonatal death; Infant development; Kangroo mother care
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: IRB/2023/1099/SIMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No