Clinical trial Recruiting at 1 site Interventional Ages 1 Day to 89

Extended Kangaroo Mother Care for Mothers of Low Birthweight Infants

Official title: Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial

Run by University of Alabama at Birmingham · NCT06545760 · Data updated 2026-11-12

This study tests if staying longer in a special Kangaroo Mother Care ward can help mothers of low birthweight babies feel less depressed after giving birth.

More Postpartum Depression trials

Quick facts

Study typeInterventional
Ages1 Day to 89 Years
SexAll
Enrollment1908 (estimated)
SponsorUniversity of Alabama at Birmingham
Academic / other
Locations1 site (Lusaka)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedJune 18, 2026
Study endsSeptember 30, 2027
Registry record updatedSeptember 17, 2026
Trial IDNCT06545760 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include mothers of low birthweight infants (1000-2000g) who are 18 years or older and reside in Lusaka.

Probably not a fit

Patients who are currently receiving treatment for depression or anxiety may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether extended admission to a Kangaroo Mother Care (KMC) ward can reduce postpartum depression in mothers of low birthweight infants in a low-resource setting. The study compares the effects of more than 2 days of KMC support against standard care on maternal mental health and infant neurodevelopmental outcomes. It also aims to identify barriers to KMC practice and assess the prevalence of paternal depression. The trial will evaluate the cost-effectiveness of KMC admission following NICU discharge.

Why it matters

Potential benefit: If successful, this approach could significantly improve maternal mental health and infant developmental outcomes in low-resource settings.

How similar studies have gone: Other studies have shown promising results with Kangaroo Mother Care, suggesting potential benefits for maternal and infant health, although this specific approach is less commonly tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

-AIM #1-2 and #5

Newborns who are:

1. Birthweight between 1000-2000gm
2. Admitted to the Women and Newborn Hospital-University Teaching Hospital (WNH-UTH) Neonatal Intensive Care Unit (NICU) \>48hrs ago
3. Stable preterm eligible for receiving KMC at the KMC Ward

And their mothers who are -

4\. 16+ years of age (Mother)

5\. Residing within Lusaka Province with no intensions to relocate in the coming 18 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. 16+ years of age (mothers and fathers)
  4. 18+ years of age (family members)
* AIM # 4:

  1. Fathers whose newborn has been enrolled into the study
  2. 16+ years of age

Exclusion Criteria:

* AIM #1-2 and #5

  1. Mothers who are on treatment for depression and/or anxiety
  2. Mothers who did not consent
  3. Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
* 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
  3. Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study

Where it's running

  • Women and Newborn Hospital - University Teaching Hospitals
    Lusaka, Zambia
    Recruiting

Study contacts

  • Principal investigator: Albert Manasyan, MD, MPH — Centre for Infectious Disease Research in Zambia
  • Study coordinator: Albert Manasyan, MD, MPH
  • Email: albert.manasyan@cidrz.org
  • Phone: +260976448994

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.