Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545760
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Admission to Kangaroo Mother Care KMC Ward and Maternal Postpartum Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 infants 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 infants 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None