Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-89
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kangaroo mother care (KMC) support for > 2 days

    Behavioral

    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

  • Kangaroo mother care (KMC) support for < 2 days

    Behavioral

    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

Treatment groups

1,908 Participants
are divided into 2 treatment groups
Group A: Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICUExperimental treatment 1 intervention
Group B: Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICUPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Mothers with Postpartum Depression (PPD)

Score on Edinburgh Postnatal Depression Scale (EPDS) screening tool obtained by interview with mother. This screening tool is a 10-question tool validated for use among pregnant women in low resource countries. It can be used for screening of perinatal depression, beginning from antenatal period up to 6-8 weeks postnatal age. Each question is scored between 0-3, the highest cumulative score being 30. Cut-off score for mothers with suspected postpartum depression (PPD) will be 11. All mothers who screen 11+ will be categorized to have PPD, all mothers scoring below 11 will be categorized as negative for PPD.

Time frame
8 weeks

Secondary outcomes

1

Percentage of Mothers with Postpartum Depression (PPD)

Score on Edinburgh Postnatal Depression Scale (EPDS) screening tool obtained by interview with mother. This screening tool is a 10-question tool validated for use among pregnant women in low resource countries. It can be used for screening of perinatal depression, beginning from antenatal period up to 6-8 weeks postnatal age. Each question is scored between 0-3, the highest cumulative score being 30. Cut-off score for mothers with suspected postpartum depression (PPD) will be 11. All mothers who screen 11+ will be categorized to have PPD, all mothers scoring below 11 will be categorized as negative for PPD.

Time frame
2 weeks, 6 months, 12 months
2

Hours spent practicing Kangaroo Mother Care (KMC) in the neonatal intensive care unit (NICU)

Time in hours and minutes spent practicing kangaroo mother care (KMC) per day by the mother obtained by interview with mother.

Time frame
2 weeks
3

Hours spent practicing Kangaroo Mother Care (KMC) in the KMC Ward

Time in hours and minutes spent practicing kangaroo mother care (KMC) per day by the mother obtained by interview with mother.

Time frame
2 weeks
4

Hours spent practicing Kangaroo Mother Care (KMC) at home

Time in hours and minutes spent practicing kangaroo mother care (KMC) per day by the mother obtained by interview with mother.

Time frame
2 weeks, 8 weeks, 6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

University Teaching Hospital, Lusaka, Zambia

Collaborator

University of Zambia

Collaborator

University of Cincinnati

Collaborator

Centre for Infectious Disease Research in Zambia

Collaborator