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

Browse trials for

• Depression, Postpartum 569
• Premature Birth 2,550

Keywords

• Low resource setting
• Kangaroo Mother Care
• Paternal depression
• Cost-effectiveness

Depression, Postpartum

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's planned enrollment of 1,908 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Study arms

• 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 admitted to an in-patient KMC ward for greater than 2 days for continued support.

  Behavioral: Kangaroo mother care (KMC) support for > 2 days

• 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 admitted to an inpatient KMC ward for less than 2 days for continued support.

  Behavioral: Kangaroo mother care (KMC) support for < 2 days

Interventions

• BehavioralKangaroo 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

  Also known as: Extended kangaroo mother care (KMC)

• BehavioralKangaroo 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

  Also known as: Routine kangaroo mother care (KMC)

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 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.

   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 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.

   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

5. Time of initiation of breastfeeding

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

   Time frame: 2 weeks

6. Number of months breastfeeding

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

   Time frame: 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).

   Time frame: 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).

   Time frame: 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).

   Time frame: 6 months,12 months, 18 months

10. Average weight in grams

    Weight in grams, weighed on a digital scale

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 28 days

14. Percentage of neonatal morbidity

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

    Time frame: 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

    Time frame: 18 months

16. Percentage of infant mortality

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

    Time frame: 18 months

17. Percentage of infant morbidity

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

    Time frame: 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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 months

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code

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.

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: Approval by the study's Data Access Committee Evidence of ethics approval from the requestor's institution Execution of a Data Use Agreement Agreement not to attempt participant re-identification Compliance with applicable Zambian data protection regulations and institutional policies Data will be shared through a secure data transfer platform or controlled-access repository.