Actively Recruiting
Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial
Led by University of Alabama at Birmingham · Updated on 2026-04-22
1908
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
U
University Teaching Hospital, Lusaka, Zambia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether extended admission to the Kangaroo Mother Care (KMC) ward can help prevent postpartum depression (PPD) in mothers of low birthweight preterm infants in low-resource settings. This randomized controlled trial compares longer KMC ward stays to the standard care of shorter stays to examine effects on maternal depression, infant neurodevelopment, paternal depression, barriers to KMC practice, and cost effectiveness. The study includes mothers, infants, fathers, and family members to understand these outcomes comprehensively. The study involves two groups: one group of mother-infant pairs admitted to the KMC ward for more than 2 days after discharge from the neonatal intensive care unit (NICU), and the other group admitted for less than 2 days. Both groups receive support for kangaroo mother care, breastfeeding, and preterm infant care during their respective ward stays before going home. The trial enrolls mothers with infants weighing between 1000-2000 grams who have been stable in the NICU for more than 48 hours. Participants will be assessed at discharge and during follow-up visits at 2 weeks, 6-8 weeks, and at 6, 12, and 18 months. Mothers and fathers will be screened for depression, and infants will undergo neurodevelopmental screenings. Researchers will also collect information on social support, breastfeeding duration, KMC barriers, infant growth, mortality, morbidity, and healthcare costs throughout the study. The trial aims to provide detailed insights into the benefits and challenges of extended KMC in this population over an 18-month period.
CONDITIONS
Brief Title
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mothers aged 16 years or older
- Newborn birthweight between 1000 and 2000 grams
- Newborn admitted to the neonatal intensive care unit for more than 48 hours
- Stable preterm infants eligible for continued kangaroo mother care in NICU or at discharge
- Residing within Lusaka Province with no plans to relocate in the next 18 months
- Parents (mothers and fathers) of enrolled newborns aged 16 or older
- Trusted family members or friends aged 18 or older of enrolled newborns
- Fathers aged 16 years or older with enrolled newborns
You will not qualify if you...
- Mothers currently receiving treatment for depression or anxiety
- Mothers who did not provide consent
- Mothers aged 16-17 years without parental consent
- Family members of parents who do not consent
- Fathers currently receiving treatment for depression or anxiety
- Fathers who did not provide informed consent
- Fathers aged 16-17 years without parental consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to a few days prior to discharge home
Participants are admitted to the Kangaroo Mother Care (KMC) ward following discharge from the neonatal intensive care unit (NICU) to receive continued support including kangaroo mother care, breastfeeding, and preterm infant care. The duration varies based on randomization, with some participants staying for more than 2 days and others for less than 2 days.
1 to 2 visits depending on length of KMC ward stay
Duration - Up to 18 months after discharge
Participants are followed after discharge from the KMC ward to monitor maternal postpartum depression, infant development, and other health outcomes. This includes assessments of kangaroo mother care practice at home, breastfeeding, and parental mental health.
Multiple follow-up visits at 2 weeks, 6-8 weeks, 6 months, 12 months, and 18 months
Trial Site Locations
Total: 1 location
1
Women and Newborn Hospital - University Teaching Hospitals
Lusaka, Zambia, 10101
Actively Recruiting
Research Team
A
Albert Manasyan, MD, MPH
J
J.Anitha Menon, MA, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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