Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-01-07 @ 10:03 PM
Study NCT ID:
NCT06545760
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2024-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KMC PPD
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.
* 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.
Detailed Description:
The overarching objective is to determine whether initiation of Kangaroo Mother Care (KMC) at the neonatal intensive care unit (NICU) followed by admission to the KMC ward for continued support for more than 2 days before discharge home reduces maternal postpartum depression (PPD) and other maternal and infant adverse outcomes in low-resource settings. The central hypothesis is that NICU KMC plus admission of mother-infant (preterm) dyads to the KMC ward following NICU discharge for more than 2 days will reduce the risk of maternal PPD as compared to NICU KMC followed by admission of the mother-infant dyad to the KMC ward for up to 2 days only.
The study aims are:
Aim 1: To determine the effect of admission of mother-infant dyads to the KMC ward following NICU for more than 2 days on maternal PPD at 2-weeks, 6-8 weeks, 6 months, and 12 months.
Aim 2: To determine the effect of admission of mother-infant dyads to the KMC ward on infant's developmental outcomes at 6-,12-, and 18 months of age.
Aim 3: To characterize the feasibility and barriers to uptake of KMC at the hospital and following discharge.
Aim 4: To determine the prevalence of paternal depression.
Aim 5: To estimate the cost and effectiveness of admission of low birthweight infants to the KMC ward:
1. Estimate costs from a health systems perspective and explore cost drivers of KMC and NICU care for low birthweight newborns
2. Assess out-of-pocket expenditure incurred by households due to admission of low birthweight infants to the KMC and NICU
3. Estimate the incremental cost-effectiveness of screening for postpartum depression among women with low birthweight infants admitted to the KMC compared to the status quo
Study design This study is a randomized controlled trial of newly delivered women whose preterm newborns have been admitted to the neonatal intensive care unit (NICU) with admission to the Kangaroo Mother Care (KMC) ward for up to 2 days (control) or with admission to the KMC ward for more than 2 days (intervention) prior to discharge home. The study will enroll a total of 1908 study participants from both study arms pulled from 612 mothers (aim #1), 612 infants (aim #2), 72 participants for in-depth interviews (aim #3), and 612 fathers (aim #4).
The study aims are:
Aim 1: To determine the effect of admission of mother-infant dyads to the KMC ward following NICU for more than 2 days on maternal PPD at 2-weeks, 6-8 weeks, 6 months, and 12 months.
Aim 2: To determine the effect of admission of mother-infant dyads to the KMC ward on infant's developmental outcomes at 6-,12-, and 18 months of age.
Aim 3: To characterize the feasibility and barriers to uptake of KMC at the hospital and following discharge.
Aim 4: To determine the prevalence of paternal depression.
Aim 5: To estimate the cost and effectiveness of admission of low birthweight infants to the KMC ward:
1. Estimate costs from a health systems perspective and explore cost drivers of KMC and NICU care for low birthweight newborns
2. Assess out-of-pocket expenditure incurred by households due to admission of low birthweight infants to the KMC and NICU
3. Estimate the incremental cost-effectiveness of screening for postpartum depression among women with low birthweight infants admitted to the KMC compared to the status quo
Study design This study is a randomized controlled trial of newly delivered women whose preterm newborns have been admitted to the neonatal intensive care unit (NICU) with admission to the Kangaroo Mother Care (KMC) ward for up to 2 days (control) or with admission to the KMC ward for more than 2 days (intervention) prior to discharge home. The study will enroll a total of 1908 study participants from both study arms pulled from 612 mothers (aim #1), 612 infants (aim #2), 72 participants for in-depth interviews (aim #3), and 612 fathers (aim #4).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: