Clinical trial NCT06559020: Predictors and Outcomes of Kangaroo Mother Care: A Quasi-Experimental Study in Pakistan
Official title: Predictors for Opting for Kangaroo Mother Care in Pakistan and Infant Development Outcomes Based on a Quasi-Experimental Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight Infants
Preterm Infants
Keywords: Kangroo mother care
Infant development
Breast feeding
Neonatal death
Vaccination
Pakistan
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2024-08-19
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Duration of Breastfeeding
timeFrame: from 2 hours to 1 year
measure: Number of babies with complete vaccination
timeFrame: 1 year
measure: Average weight of baby
timeFrame: 1 year
measure: average length of infant
timeFrame: 1 year
measure: Average head circumference of infant
timeFrame: 1 year
measure: Number of babies Holding head up
timeFrame: 3 months
measure: Number of babies Sitting without support
timeFrame: 6 months
measure: Number of babies roll over
timeFrame: 8 months
measure: Number of babies crawling
timeFrame: 10 months
measure: Number of babies babbles
timeFrame: 6 months
measure: Number of babies produce 2 syllable sounds
timeFrame: 9 months
measure: cumulative Mortality rate
timeFrame: 1 year
Secondary outcomes:
measure: Number of babies with Hypothermia
timeFrame: 72 hours
measure: Number of babies with Sepsis
timeFrame: 72 hours
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical sciences
state: Punjab
Study officials:
affiliation: Services Institute of Medical Sciences, Pakistan
name: Tayyiba Wasim, FCPS
role: PRINCIPAL_INVESTIGATOR
References: