NCT06545760 Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
| NCT ID | NCT06545760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Low Birth Weight |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,908 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,908 participants in total. It began in 2024-12-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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) 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
Contact & Investigator
Albert Manasyan, MD, MPH
PRINCIPAL INVESTIGATOR
Centre for Infectious Disease Research in Zambia
Frequently Asked Questions
Who can join the NCT06545760 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 89 Years, studying Low Birth Weight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06545760 currently recruiting?
Yes, NCT06545760 is actively recruiting participants. Contact the research team at albert.manasyan@cidrz.org for enrollment information.
Where is the NCT06545760 trial being conducted?
This trial is being conducted at Lusaka, Zambia.
Who is sponsoring the NCT06545760 clinical trial?
NCT06545760 is sponsored by University of Alabama at Birmingham. The principal investigator is Albert Manasyan, MD, MPH at Centre for Infectious Disease Research in Zambia. The trial plans to enroll 1,908 participants.