Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

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

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

‣ 18+ years of age

⁃ AIM # 4:

∙ Fathers whose newborn has been enrolled into the study

‣ 18+ years of age (father)

Locations
Other Locations
Zambia
Women and Newborn Hospital - University Teaching Hospitals
RECRUITING
Lusaka
Contact Information
Primary
Albert Manasyan, MD, MPH
albert.manasyan@cidrz.org
+260976448994
Backup
J.Anitha Menon, MA, PhD
AnithaMenon316@gmail.com
+260977846116
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 1908
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: University Teaching Hospital, Lusaka, Zambia, University of Cincinnati, Centre for Infectious Disease Research in Zambia, University of Zambia

This content was sourced from clinicaltrials.gov