Review the details below, then apply to join this clinical trial.
At a Glance
Age
1 Day – 89
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
1,908 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for mothers of low birthweight infants who were in the neonatal intensive care unit. Participants will spend time in the Kangaroo Mother Care ward with their babies and attend follow-up visits to check on both their mental health and their baby's development.
Are You a Good Fit for This Trial?
You may be able to join if
I have a baby that weighs between 1000-2000 grams.
I am at least 16 years old.
I live in Lusaka Province and plan to stay here for 18 months.
My baby was admitted to the neonatal care unit for more than 48 hours.
My baby is stable and eligible for Kangaroo Mother Care.
You may not be able to join if
I am being treated for depression or anxiety.
I did not consent to participate.
I am under 16 years old and my parents did not give consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 p…
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.
Trial Locations
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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 (K…
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
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