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

Summary

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.

Conditions

• Low Birth Weight
• Kangaroo Mother Care
• Postpartum Depression
• Neurodevelopmental Outcome
• Pre-Term

Interventions

BEHAVIORAL

Kangaroo mother care (KMC) support for > 2 days

Admission to the kangaroo mother care (KMC) ward with continued support of kangaroo mother care, breastfeeding, and preterm infant care for greater than 2 days prior to discharge home

BEHAVIORAL

Kangaroo mother care (KMC) support for < 2 days

Admission to the kangaroo mother care (KMC) ward with continued support of kangaroo mother care, breastfeeding, and preterm infant care for less than 2 days prior to discharge home

Sponsors & Collaborators

• University Teaching Hospital, Lusaka, Zambia

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• Centre for Infectious Disease Research in Zambia

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Albert Manasyan, MD, MPH · Centre for Infectious Disease Research in Zambia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-06-30

Completion

2027-09-30

Countries

• Zambia

Study Locations