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Low Birth WeightKMC PPDNCT06545760

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

A study testing Kangaroo mother care (KMC) support for > 2 days and Kangaroo mother care (KMC) support for < 2 days in people with Low Birth Weight and Kangaroo Mother Care, run by University of Alabama at Birmingham at 1 site in Zambia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 89 years
What is being tested?
Kangaroo mother care (KMC) support for > 2 days and Kangaroo mother care (KMC) support for < 2 days
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,908 participants
Where
1 siteZambia
Study dates
1 Dec 2024to 30 Sep 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 89 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • -AIM #1-2 and #5
  • Newborns who are:
  • Birthweight between 1000-2000gm
  • Admitted to the Women and Newborn Hospital-University Teaching Hospital (WNH-UTH) Neonatal Intensive Care Unit (NICU) >48hrs ago
  • Stable preterm eligible for receiving KMC at the KMC Ward
  • And their mothers who are -
Show all 16Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Albert Manasyan, MD, MPH contact

+260976448994

albert.manasyan@cidrz.org

J.Anitha Menon, MA, PhD contact

+260977846116

AnithaMenon316@gmail.com

Zambia1 site, 1 recruiting
  • Women and Newborn Hospital - University Teaching Hospitals

    Lusaka, 10101

    Jyoti Lakhwani, MD, 00260976247685, jyoti.lakhwani90@gmail.com

    Recruiting

Other trials in Zambia

About this study

Official title: Admission to the Kangaroo Mother Care Ward and Maternal Postpartum Depression: A Randomized Controlled 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?
Read more

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.
Read the 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), up to 612 infants (aim #2), up to 72 participants for in-depth interviews (aim #3), and up to 612 fathers (aim #4).

Being tested
Kangaroo mother care (KMC) support for > 2 days, Kangaroo mother care (KMC) support for < 2 days
Keywords
Low resource setting, Kangaroo Mother Care, Paternal depression, Cost-effectiveness
Medical subject headings
Depression, Postpartum, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Extended kangaroo mother care (KMC)

    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 daysBehavioural

    Also called Routine kangaroo mother care (KMC)

    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

Study groups in NCT06545760
Study groupRoleWhat they receive
Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICUExperimentalFollowing discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be admitted to an in-patient KMC ward for greater than 2 days for continued support.
Receives: Behavioral: Kangaroo mother care (KMC) support for > 2 days
Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICUPlacebo comparatorFollowing discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be admitted to an inpatient KMC ward for less than 2 days for continued support.
Receives: Behavioral: Kangaroo mother care (KMC) support for < 2 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 during the antenatal and postnatal periods. 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.

    Measured: 8 weeks

Secondary outcomes (30)
  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 during the antenatal and postnatal periods. 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 2 weeks, 8 weeks, 6 months, 12 months

  5. Time of initiation of breastfeeding

    Time in hours and minutes after delivery, when infant is initially put to breast for feeding

    Measured: 2 weeks

  6. Number of months breastfeeding

    Number of months of any breastfeeding reported by the mother in an interview

    Measured: 8 weeks, 6 months, 12 months

  7. Number of barriers to kangaroo mother care (KMC) initiation at the birth hospital

    A pre-defined set of questions will be asked to all the mothers to determine the barriers contributing to kangaroo mother care (KMC) initiation at the birth hospital. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  8. Number of barriers to kangaroo mother care (KMC) initiation at home

    A pre-defined set of questions will be asked to all the mothers to determine the barriers contributing to kangaroo mother care (KMC) initiation at home. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  9. Average Infant/child developmental assessment

    Score on "Ages and Stages Questionnaire" (ASQ) obtained by interview with parent developmental assessment tools which scores items (Y = 10, Sometimes = 5, Not Yet = 0) in areas of Communication, Gross motor, Fine Motor, Problem Solving and Personal-Social. Scoring of items are totaled and placed on a graph indicating cut off score. If score is above cut-off, the child's development appears to be on schedule; near the cutoff, may provide learning activities and monitor; and below cutoff, requiring further assessment.

    6-month cutoffs (Communication 29.65; Gross Motor 22.25; Fine Motor 25.14; Problem Solving 27.72 and Personal-Social 25.34); 12-month cutoffs (Communication 15.64; Gross Motor 21.49; Fine Motor 34.50; Problem Solving 27.32 and Personal-Social 21.73); 18-month cutoffs (Communication 13.06; Gross Motor 37.38; Fine Motor 34.32; Problem Solving 25.74 and Personal-Social 27.19).

    Measured: 6 months,12 months, 18 months

  10. Average weight in grams

    Weight in grams, weighed on a digital scale

    Measured: birth, up to 8 weeks, 6 months, 12 months, 18 months

  11. Average length in centimeters (cm)

    Length in centimeters, top of head to heel, measured with paper tape measure

    Measured: birth, up to 8 weeks, 6 months, 12 months, 18 months

  12. Average head Circumference in centimeters (cm)

    Head Circumference in centimeters (cm), occipital-frontal, measured with paper tape measure

    Measured: birth, up to 8 weeks, 6 months, 12 months, 18 months

  13. Percentage of all cause 28-day neonatal mortality

    Report of neonatal vital status within 28 days, obtained in maternal interview

    Measured: 28 days

  14. Percentage of neonatal morbidity

    Report of neonatal health status, obtained in maternal interview (e.g., neonatal sepsis, diarrhoea, breathing difficulties)

    Measured: 28 days

  15. Percentage of infant readmission to facility

    Neonatal rehospitalization after initial discharge from the hospital assessed by maternal interview or medical records documentation

    Measured: 18 months

  16. Percentage of infant mortality

    Documentation of or report of infant death, assessed through medical records or maternal interview

    Measured: 18 months

  17. Percentage of infant morbidity

    Report of infant morbidity, assessed through maternal interview (e.g., diarrhoea, pneumonia, sepsis, respiratory infections)

    Measured: 18 months

  18. Percentage of vaccine adherence

    Report of infant's adherence to the required vaccinations per national guidelines in Zambia through maternal interview -

    Bacille Calmette-Guérin (BCG) - at birth Polio (Oral Polio Virus 0, 1, 2, 3) - birth, 6, 10, and 14 weeks Diphtheria, tetanus, whooping cough (pertussis) or DTP, polio, hepatitis B and Haemophilus influenzae type b (Hib) - DPT-HepB-HiiB (1, 2, 3) - at 6, 10, and 14 weeks Measles - at 9 and 18 months Rotavirus 1, 2 - at 6 and 14 weeks Preumococcal Vaccine (PCV) 1, 2 - at 6, 10, and 14 weeks

    Measured: 12 months

  19. Number of barriers to practicing kangaroo mother care (KMC() at the hospital

    A pre-defined set of questions will be asked to determine the barriers contributing to practicing kangaroo mother care (KMC) initiation at the hospital. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  20. Number of facilitators to practicing kangaroo mother care (KMC) at the hospital

    A pre-defined set of questions will be asked to determine the facilitators contributing to practicing kangaroo mother care (KMC) initiation at the hospital. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  21. Number of barriers to practicing kangaroo mother care (KMC) at home

    A pre-defined set of questions will be asked to determine the barriers contributing to practicing kangaroo mother care (KMC) initiation at home. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  22. Number of facilitators to practicing kangaroo mother care (KMC) at home

    A pre-defined set of questions will be asked to all the mothers to determine the facilitators contributing to practicing kangaroo mother care (KMC) initiation at home. The Investigators will enroll mothers (n=24), fathers (n=24), and family members (n=24) to undergo in-depth interviews (IDIs).

    Measured: 12 months

  23. Percentage of fathers with postpartum depression

    Score on Edinburg Postnatal Depression Scale (EPDS) screening tool obtained by interview with the father. 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 the postnatal period. Each question is scored between 0-3, the highest cumulative score being 30. Cut-off score for fathers with suspected postpartum depression (PPD) will be 9. All fathers who screen 9+ will be categorized to have PPD, all fathers scoring below 9 will be categorized as negative for PPD.

    Measured: 2 weeks, 8 weeks, 6 months, 12 months

  24. Hours of time father spent with newborn daily

    Time (hours/minutes) spent interacting with the newborn/infant each day obtained by interview with the father

    Measured: 8 weeks, 6 months, 12 months

  25. Percentage of mothers with depression

    Patient Health Questionnaire (PHQ-9) is a 9-question patient-administered screening tool for the assessment of depression among mothers and fathers. Since PHQ-9 can be used repeatedly to monitor depressive symptoms among the same patient/study participant, it will be used at different time points throughout the study. The severity scale is as follows:

    1. None: 0-4
    2. Mild: 5-9
    3. Moderate: 10-14
    4. Moderate-Severe: 15-19
    5. Severe: 20-27

    Measured: 2 weeks, 8 weeks, 6 months, and 12 months

  26. Percentage of mothers with self-reported perceived social support

    Multidimensional Scale of Perceived Social Support (MSPSS) is a tool for screening of perceived social support from family, friends, and significant other.] It, a brief and easy-to-follow self-report measure, is a 12-question tool using a 5-point Likert scale (0 = strongly disagree, 5 = strongly agree). It uses positive and negative phrasing to limit response set bias of agreement. Mothers enrolled in the study will be screened using the MSPSS screening tool at 6 and 12 months following enrolment. This total score can also be calculated as a mean score (divide by 12). To calculate the mean subscale scores:

    • Significant Other Subscale: Sum across items 1, 2, 5, \& 10, then divide by 4.
    • Family Subscale: Sum across items 3, 4, 8, \& 11, then divide by 4.
    • Friends Subscale: Sum across items 6, 7, 9, \& 12, then divide by 4.

    Scores are divided into:

    1. Low support: 1 to 2.9
    2. Moderate support: 3 to 5
    3. High support: 5.1 to 7

    Measured: 6 months, 12 months

  27. Cost of admission to kangaroo mother care (KMC) ward

    Government funds spent by the government for admission of one newborn to the kangaroo mother care (KMC) ward per day obtained from government sources. This will estimate the average cost per patient admitted to the KMC ward.

    Measured: Through KMC discharge of up to 8 weeks

  28. Cost of readmission to the neonatal intensive care unit (NICU)

    Funds spent by the government for readmission of one newborn to the neonatal intensive care unit (NICU) per day obtained from government sources. This will estimate the average cost per patient admitted to the NICU.

    Measured: Through NICU discharge of up to 8 weeks

  29. Cost associated with hospital readmissions

    Funds spent by the government for readmission of one infant to the hospital per day obtained from government sources. This will estimate the average cost per patient readmitted to the hospital.

    Measured: 12 months

  30. Out-of-pocket family costs associated with hospital readmissions

    Funds spent by the family associated with readmission of one infant to the hospital per day obtained from maternal interview. This will estimate the average funds spent by the family per patient readmitted to the hospital.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start1 Dec 2024
  3. Primary completion18 Jun 2026
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,908 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06545760
Sponsor's protocol ID
UAB-300012872
Other IDs
TTS-2404-65126, 000544699
Acronym
KMC PPD
Status last verified
Sep 2026
First submitted
1 Aug 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in the primary publication, including maternal, paternal, and infant demographic characteristics, baseline maternal and paternal psychosocial variables, validated postpartum depression assessment scores, randomized intervention allocation, follow-up maternal and paternal mental health outcomes, relevant neonatal clinical variables collected as part of the study, and neurodevelopmental screening data of the infant. All direct identifiers will be removed. Indirect identifiers will be coded or aggregated to minimize re-identification risk in accordance with ethical and regulatory requirements in Zambia.

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