Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT06545760
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 (KMC) in the NICU or NICU discharge 4) 18+ years of age (Mother) 5) Residing within Lusaka with no intensions to relocate in the coming 12 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. 18+ years of age
* AIM # 4:
1. Fathers whose newborn has been enrolled into the study
2. 18+ 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
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
89 Years
Study:
NCT06545760
Study Brief:
Protocol Section:
NCT06545760