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

NCT ID: NCT06545760

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1908 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-02-28

Brief 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.

Detailed Description

The overarching objective is to determine whether initiation of Kangaroo Mother Care (KMC) at the neonatal intensive care unit (NICU) followed by admission to the KMC ward for continued support for more than 2 days before discharge home reduces maternal postpartum depression (PPD) and other maternal and infant adverse outcomes in low-resource settings. The central hypothesis is that NICU KMC plus admission of mother-infant (preterm) dyads to the KMC ward following NICU discharge for more than 2 days will reduce the risk of maternal PPD as compared to NICU KMC followed by admission of the mother-infant dyad to the KMC ward for up to 2 days only.

The study aims are:

Aim 1: To determine the effect of admission of mother-infant dyads to the KMC ward following NICU for more than 2 days on maternal PPD at 2-weeks, 6-8 weeks, 6 months, and 12 months.

Aim 2: To determine the effect of admission of mother-infant dyads to the KMC ward on infant's developmental outcomes at 6-,12-, and 18 months of age.

Aim 3: To characterize the feasibility and barriers to uptake of KMC at the hospital and following discharge.

Aim 4: To determine the prevalence of paternal depression.

Aim 5: To estimate the cost and effectiveness of admission of low birthweight infants to the KMC ward:

1. Estimate costs from a health systems perspective and explore cost drivers of KMC and NICU care for low birthweight newborns

2. Assess out-of-pocket expenditure incurred by households due to admission of low birthweight infants to the KMC and NICU

3. Estimate the incremental cost-effectiveness of screening for postpartum depression among women with low birthweight infants admitted to the KMC compared to the status quo

Study design This study is a randomized controlled trial of newly delivered women whose preterm newborns have been admitted to the neonatal intensive care unit (NICU) with admission to the Kangaroo Mother Care (KMC) ward for up to 2 days (control) or with admission to the KMC ward for more than 2 days (intervention) prior to discharge home. The study will enroll a total of 1908 study participants from both study arms pulled from 612 mothers (aim #1), 612 infants (aim #2), 72 participants for in-depth interviews (aim #3), and 612 fathers (aim #4).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICU

Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for greater than 2 days for continued support.

Group Type: EXPERIMENTAL

Kangaroo mother care (KMC) support for > 2 days

Intervention Type: BEHAVIORAL

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

Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICU

Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for less than 2 days for continued support.

Group Type: PLACEBO_COMPARATOR

Kangaroo mother care (KMC) support for < 2 days

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

Extended kangaroo mother care (KMC); Routine kangaroo mother care (KMC)

Eligibility Criteria

Inclusion Criteria

-AIM #1-2 and #5

Mothers to newborns who are:

1) Birthweight between 1000-2000gm 2) Admitted to the Women and Neonates Hospital-University Teaching Hospital Neonatal Intensive Care Unit (WNH-UTH NICU) (>48hrs) 3) Stable preterm eligible for continuing kangaroo mother care (KMC) in the NICU or NICU discharge 4) 18+ years of age (Mother) 5) Residing within Lusaka with no intensions to relocate in the coming 12 months

• AIM #3

1. Parents (mothers and fathers) whose newborn has been enrolled in the study

2. Trusted family member or friend of the mother whose newborns is enrolled into the study

3. 18+ years of age

• AIM # 4:

1. Fathers whose newborn has been enrolled into the study

2. 18+ years of age (father)

Exclusion Criteria

• AIM #1-2 and #5

1. Mothers who are on treatment for depression and/or anxiety

2. Mothers who did not consent

• AIM #3

1) Family members of parents who do not consent to study participation

• AIM # 4:

1. Fathers who are on treatment for depression and/or anxiety

2. Fathers who did not provide informed consent

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role: collaborator

University of Zambia

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Centre for Infectious Disease Research in Zambia

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Albert Manasyan, MD, MPH

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Albert Manasyan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Centre for Infectious Disease Research in Zambia

Locations

Women and Newborn Hospital - University Teaching Hospitals

Lusaka, Lusaka Province, Zambia

Site Status: RECRUITING

Countries

Zambia

Central Contacts

Albert Manasyan, MD, MPH

Role: CONTACT

albert.manasyan@cidrz.org

+260976448994

J.Anitha Menon, MA, PhD

Role: CONTACT

AnithaMenon316@gmail.com

+260977846116

Facility Contacts

Jyoti Lakhwani, MD

Role: primary

jyoti.lakhwani90@gmail.com

00260976247685

Other Identifiers

TTS-2404-65126

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

000544699

Identifier Type: OTHER

Identifier Source: secondary_id

UAB-300012872

Identifier Type: -

Identifier Source: org_study_id