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

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?

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Low Birth Weight; Pre-Term; Kangaroo Mother Care; Neurodevelopmental Outcome
• Intervention / Treatment: Behavioral: Kangaroo mother care (KMC) support for > 2 days; Behavioral: Kangaroo mother care (KMC) support for < 2 days

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).

• Study Type: Interventional
• Enrollment (Estimated): 1908
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Albert Manasyan, MD, MPH; Phone Number: +260976448994; Email: albert.manasyan@cidrz.org
• Study Contact Backup: Name: J.Anitha Menon, MA, PhD; Phone Number: +260977846116; Email: AnithaMenon316@gmail.com

Study Locations

• Zambia
  • Lusaka, Zambia, 10101
    • Recruiting
    • Women and Newborn Hospital - University Teaching Hospitals
    • Contact: Jyoti Lakhwani, MD; Phone Number: 00260976247685; Email: jyoti.lakhwani90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

  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. 16+ years of age (mothers and fathers)
  4. 18+ years of age (family members)

• AIM # 4:

  1. Fathers whose newborn has been enrolled into the study
  2. 16+ 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
  3. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Admission to Kangaroo Mother Care (KMC) ward for > 2 days after discharge from NICU; Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for greater than 2 days for continued support.	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; Other Names: Extended kangaroo mother care (KMC)
Placebo Comparator: Admission to Kangaroo Mother Care (KMC) ward for < 2 days after discharge from NICU; Following discharge from the neonatal intensive care unit (NICU), preterm mothers and their infants will be discharged to an inpatient kangaroo mother care (KMC) ward for less than 2 days for continued support.	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; Other Names: Routine kangaroo mother care (KMC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks, 6 months, 12 months
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.	2 weeks
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.	2 weeks
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.	2 weeks, 8 weeks, 6 months, 12 months
Time of initiation of breastfeeding	Time in hours and minutes after delivery, when infant is initially put to breast for feeding	2 weeks
Number of months breastfeeding	Number of months of any breastfeeding reported by the mother in an interview	8 weeks, 6 months, 12 months
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).	12 months
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).	12 months
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).	6 months,12 months, 18 months
Average weight in grams	Weight in grams, weighed on a digital scale	birth, up to 8 weeks, 6 months, 12 months, 18 months
Average length in centimeters (cm)	Length in centimeters, top of head to heel, measured with paper tape measure	birth, up to 8 weeks, 6 months, 12 months, 18 months
Average head Circumference in centimeters (cm)	Head Circumference in centimeters (cm), occipital-frontal, measured with paper tape measure	birth, up to 8 weeks, 6 months, 12 months, 18 months
Percentage of all cause 28-day neonatal mortality	Report of neonatal vital status within 28 days, obtained in maternal interview	28 days
Percentage of neonatal morbidity	Report of neonatal health status, obtained in maternal interview (e.g., neonatal sepsis, diarrhoea, breathing difficulties)	28 days
Percentage of infant readmission to facility	Neonatal rehospitalization after initial discharge from the hospital assessed by maternal interview or medical records documentation	18 months
Percentage of infant mortality	Documentation of or report of infant death, assessed through medical records or maternal interview	18 months
Percentage of infant morbidity	Report of infant morbidity, assessed through maternal interview (e.g., diarrhoea, pneumonia, sepsis, respiratory infections)	18 months
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	12 months
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).	12 months
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).	12 months
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).	12 months
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).	12 months
Percentage of fathers with postpartum depression	Score on Edinburg 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 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.	2 weeks, 8 weeks, 6 months, 12 months
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	8 weeks, 6 months, 12 months
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: None: 0-4; Mild: 5-9; Moderate: 10-14; Moderate-Severe: 15-19; Severe: 20-27	2 weeks, 8 weeks, 6 months, and 12 months
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: Low support: 1 to 2.9; Moderate support: 3 to 5; High support: 5.1 to 7	6 months, 12 months
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.	Through KMC discharge of up to 8 weeks
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.	Through NICU discharge of up to 8 weeks
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.	12 months
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.	12 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of Cincinnati; Centre for Infectious Disease Research in Zambia; University of Zambia; University Teaching Hospital, Lusaka, Zambia
• Investigators: Principal Investigator: Albert Manasyan, MD, MPH, Centre for Infectious Disease Research in Zambia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cost-effectiveness; Kangaroo Mother Care; Low resource setting; Paternal depression
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Premature Birth; Depression, Postpartum; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Infant Care; Child Care; Patient Positioning; Palliative Care; Kangaroo-Mother Care Method
• Other Study ID Numbers: UAB-300012872; TTS-2404-65126 (Other Grant/Funding Number: Grand Challenges Canada); 000544699 (Other Identifier: UAB OSP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be made available beginning 12 months following publication of the primary study results and will remain available for up to 5 years after publication.

IPD Sharing Access Criteria

Data will be available to qualified researchers who submit a scientifically sound research proposal consistent with the objectives of the original study and compliant with ethical standards.

Access will require:

1. Approval by the study's Data Access Committee
2. Evidence of ethics approval from the requestor's institution
3. Execution of a Data Use Agreement
4. Agreement not to attempt participant re-identification
5. Compliance with applicable Zambian data protection regulations and institutional policies

Data will be shared through a secure data transfer platform or controlled-access repository.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No