Extended Kangaroo Mother Care for Mothers of Low Birthweight Infants
Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled Trial
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1908 (estimated) |
| Ages | 1 Day to 89 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Lusaka) |
| Trial ID | NCT06545760 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include mothers of low birthweight infants (1000-2000g) who are 18 years or older and reside in Lusaka.
Not a fit: Patients who are currently receiving treatment for depression or anxiety may not benefit from this study.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion 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) 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 (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 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 this trial is running
Lusaka
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.