Clinical trial NCT06545760: Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Official title: Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Birth Weight
Kangaroo Mother Care
Postpartum Depression
Neurodevelopmental Outcome
Pre-Term
Keywords: Low resource setting
Kangaroo Mother Care
Paternal depression
Cost-effectiveness
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital, Lusaka, Zambia
name: University of Zambia
name: University of Cincinnati
name: Centre for Infectious Disease Research in Zambia
First posted: 2024-08-09
Enrollment: 1908
Sex: ALL
Minimum age (years): 1
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

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) 18+ years of age (Mother) 5) Residing within Lusaka with no intensions to relocate in the coming 12 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. 18+ years of age
* AIM # 4:

  1. Fathers whose newborn has been enrolled into the study
  2. 18+ 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
* 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

Primary outcomes:
measure: Percentage of Mothers with Postpartum Depression (PPD)
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Mothers with Postpartum Depression (PPD)
timeFrame: 2 weeks, 6 months, 12 months
measure: Hours spent practicing Kangaroo Mother Care (KMC) in the neonatal intensive care unit (NICU)
timeFrame: 2 weeks
measure: Hours spent practicing Kangaroo Mother Care (KMC) in the KMC Ward
timeFrame: 2 weeks
measure: Hours spent practicing Kangaroo Mother Care (KMC) at home
timeFrame: 2 weeks, 8 weeks, 6 months, 12 months
measure: Time of initiation of breastfeeding
timeFrame: 2 weeks
measure: Number of months breastfeeding
timeFrame: 8 weeks, 6 months, 12 months
measure: Number of barriers to kangaroo mother care (KMC) initiation at the birth hospital
timeFrame: 12 months
measure: Number of barriers to kangaroo mother care (KMC) initiation at home
timeFrame: 12 months
measure: Average Infant/child developmental assessment
timeFrame: 6 months,12 months, 18 months
measure: Average weight in grams
timeFrame: birth, up to 8 weeks, 6 months, 12 months, 18 months
measure: Average length in centimeters (cm)
timeFrame: birth, up to 8 weeks, 6 months, 12 months, 18 months
measure: Average head Circumference in centimeters (cm)
timeFrame: birth, up to 8 weeks, 6 months, 12 months, 18 months
measure: Percentage of all cause 28-day neonatal mortality
timeFrame: 28 days
measure: Percentage of neonatal morbidity
timeFrame: 28 days
measure: Percentage of infant readmission to facility
timeFrame: 18 months
measure: Percentage of infant mortality
timeFrame: 18 months
measure: Percentage of infant morbidity
timeFrame: 18 months
measure: Percentage of vaccine adherence
timeFrame: 12 months
measure: Number of barriers to practicing kangaroo mother care (KMC() at the hospital
timeFrame: 12 months
measure: Number of facilitators to practicing kangaroo mother care (KMC) at the hospital
timeFrame: 12 months
measure: Number of barriers to practicing kangaroo mother care (KMC) at home
timeFrame: 12 months
measure: Number of facilitators to practicing kangaroo mother care (KMC) at home
timeFrame: 12 months
measure: Percentage of fathers with postpartum depression
timeFrame: 2 weeks, 8 weeks, 6 months, 12 months
measure: Hours of time father spent with newborn daily
timeFrame: 8 weeks, 6 months, 12 months
measure: Percentage of mothers with depression
timeFrame: 2 weeks, 8 weeks, 6 months, and 12 months
measure: Percentage of mothers with self-reported perceived social support
timeFrame: 6 months, 12 months
measure: Cost of admission to kangaroo mother care (KMC) ward
timeFrame: Through KMC discharge of up to 8 weeks
measure: Cost of readmission to the neonatal intensive care unit (NICU)
timeFrame: Through NICU discharge of up to 8 weeks
measure: Cost associated with hospital readmissions
timeFrame: 12 months
measure: Out-of-pocket family costs associated with hospital readmissions
timeFrame: 12 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Women and Newborn Hospital - University Teaching Hospitals
Study officials:
affiliation: Centre for Infectious Disease Research in Zambia
name: Albert Manasyan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: