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Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression

Study acronym: KMC PPD
StatusRecruiting
PhaseNot applicable
Started2024-12-01
View on ClinicalTrials.gov ↗
The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are: * Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting? * Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting? * What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting? * What is the prevalence of paternal depression in a low resource setting? * Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will: * At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge. * Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression. * Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.

Amendment record

Amended 7 times since 2024-08-08; most recent filed 2026-06-18. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-06-18
Amendment Study Status v7
2026-04-17
Amendment Study Status, Study Description v6
2026-03-02
Amendment Study Identification, Study Status, Oversight, Study Description, Eligibility, Contacts/Locations, IPDSharing v5
2025-03-04
Amendment Study Identification, Study Status, Oversight, Study Design, Contacts/Locations v4
2024-12-10
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v3
2024-10-07
Amendment Study Identification, Study Status, Oversight, Contacts/Locations v2
2024-09-04
Amendment Study Identification, Study Status, Oversight, Contacts/Locations v1
2024-08-08
Original filing
Trial Details
NCT Number NCT06545760
Lead Sponsor University of Alabama at Birmingham
Collaborators: University Teaching Hospital, Lusaka, Zambia, University of Zambia, University of Cincinnati, Centre for Infectious Disease Research in Zambia
Conditions Low Birth Weight, Kangaroo Mother Care, Postpartum Depression, Neurodevelopmental Outcome, Pre-Term
Enrollment 1,908 participants
Start Date 2024-12-01
Primary Completion 2026-06-18 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22