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Life sciences · Interventional Study
ClinicalTrials.gov · September 17, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06545760). This is a study registration, not published results. Lead sponsor: University of Alabama at Birmingham. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1908 participants (ESTIMATED). Conditions: Low Birth Weight, Kangaroo Mother Care, Postpartum Depression, Neurodevelopmental Outcome, Pre-Term. Interventions: BEHAVIORAL: Kangaroo mother care (KMC) support for > 2 days; BEHAVIORAL: Kangaroo mother care (KMC) support for < 2 days. Primary outcome measures: Percentage of Mothers with Postpartum Depression (PPD) , 8 weeks. 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.