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

NCT06559020 | Completed

• 1 other identifier: IRB/2023/1099/SIMS
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Birth Weight Infants; Preterm Infants

Keywords

Kangroo mother care; Infant development; Breast feeding; Neonatal death; Vaccination; Pakistan

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (2)

• Number of babies with Hypothermia

  72 hours

• Number of babies with Sepsis

  72 hours

Study Arms (2)

kangroo mother care

EXPERIMENTAL

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

conventional care

NO INTERVENTION

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.

Interventions

Kangroo mother care BEHAVIORAL

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.

kangroo mother care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Breast Feeding; Perinatal Death

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tayyiba Wasim, FCPS

  Services Institute of Medical Sciences, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Obstetrics & Gynaecology

Model Details: This study employs a quasi-experimental design with parallel assignment. Participants were self-selected into two groups: one receiving Kangaroo Mother Care (KMC) and the other receiving Conventional Care (CC). The intervention was applied without randomization, and both groups were followed for one year to assess differences in growth, developmental milestones, breastfeeding practices, vaccination status, and mortality among low birth weight and preterm infants.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 19, 2024
• Study Start: January 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

PA (1)