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

Overview

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 for more than 2 days 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 from the perspective of parents and other family members.

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.

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).

Interventions

• Behavioral Kangaroo mother care (KMC) support for > 2 days
  Admission to the kangaroo mother care (KMC) ward with continued support of kangaroo mother care, breastfeeding, and preterm infant care for greater than 2 days prior to discharge home
• Behavioral Kangaroo mother care (KMC) support for < 2 days
  Admission to the kangaroo mother care (KMC) ward with continued support of kangaroo mother care, breastfeeding, and preterm infant care for less than 2 days prior to discharge home

Primary outcome measures

• Percentage of Mothers with Postpartum Depression (PPD) [Time frame: 8 weeks]

Secondary outcome measures (12)

• Percentage of Mothers with Postpartum Depression (PPD) [Time frame: 2 weeks, 6 months, 12 months]
• Hours spent practicing Kangaroo Mother Care (KMC) in the neonatal intensive care unit (NICU) [Time frame: 2 weeks]
• Hours spent practicing Kangaroo Mother Care (KMC) in the KMC Ward [Time frame: 2 weeks]
• Hours spent practicing Kangaroo Mother Care (KMC) at home [Time frame: 2 weeks, 8 weeks, 6 months, 12 months]
• Time of initiation of breastfeeding [Time frame: 2 weeks]
• Number of months breastfeeding [Time frame: 8 weeks, 6 months, 12 months]
• Number of barriers to kangaroo mother care (KMC) initiation at the birth hospital [Time frame: 12 months]
• Number of barriers to kangaroo mother care (KMC) initiation at home [Time frame: 12 months]
• Average Infant/child developmental assessment [Time frame: 6 months,12 months, 18 months]
• Average weight in grams [Time frame: birth, up to 8 weeks, 6 months, 12 months, 18 months]
• Average length in centimeters (cm) [Time frame: birth, up to 8 weeks, 6 months, 12 months, 18 months]
• Average head Circumference in centimeters (cm) [Time frame: birth, up to 8 weeks, 6 months, 12 months, 18 months]

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) 16+ years of age (Mother) 5) Residing within Lusaka Province with no intensions to relocate in the coming 18 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
• 16+ years of age (mothers and fathers)
• 18+ years of age (family members)
• AIM # 4:

• Fathers whose newborn has been enrolled into the study
• 16+ years of age (father)

Exclusion criteria

• AIM #1-2 and #5

• Mothers who are on treatment for depression and/or anxiety
• Mothers who did not consent
• Underage mothers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study
• AIM #3

1\) Family members of parents who do not consent to study participation

• AIM # 4:

• Fathers who are on treatment for depression and/or anxiety
• Fathers who did not provide informed consent
• Underage fathers (16-17 years of age) whose parent(s) has not provided consent for their participation in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Zambia · 1 center

• Women and Newborn Hospital - University Teaching Hospitals — Lusaka

Identifiers

NCT: NCT06545760 · UAB-300012872 · TTS-2404-65126 · 000544699

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗