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Completed

NCT Number: NCT06559020

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Services Institute of Medical sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Duration of Breastfeeding

    Time frame: from 2 hours to 1 year

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

  2. Number of babies with complete vaccination

    Time frame: 1 year

    infant receiving all scheduled vaccinations within their first year of life

  3. Average weight of baby

    Time frame: 1 year

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

  4. average length of infant

    Time frame: 1 year

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

  5. Average head circumference of infant

    Time frame: 1 year

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

  6. Number of babies Holding head up

    Time frame: 3 months

    baby able to hold their head up

  7. Number of babies Sitting without support

    Time frame: 6 months

    Baby gets into sitting position without help

  8. Number of babies roll over

    Time frame: 8 months

    baby able to roll from side to side

  9. Number of babies crawling

    Time frame: 10 months

    baby able to move forward on hands and knees

  10. Number of babies babbles

    Time frame: 6 months

    baby able to produce repititive incomprehensible sounds

  11. Number of babies produce 2 syllable sounds

    Time frame: 9 months

    baby able to produce words that have two definite sounds

  12. cumulative Mortality rate

    Time frame: 1 year

    Death of baby

Secondary outcomes

  1. Number of babies with Hypothermia

    Time frame: 72 hours

    core body temperature less than 35 degree celsius

  2. Number of babies with Sepsis

    Time frame: 72 hours

    infection leading to life threatening inflammatory response

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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