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

NCT ID: NCT06559020

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Birth Weight Infants Preterm Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Kangroo mother care

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tayyiba Wasim

Professor Obstetrics & Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tayyiba Wasim, FCPS

Role: PRINCIPAL_INVESTIGATOR

Services Institute of Medical Sciences, Pakistan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Services Institute of Medical sciences

Lahore, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB/2023/1099/SIMS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.