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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT07231432
Eligibility Criteria:
AIM 1
Mothers
* Mothers of former low birthweight (\<2500 grams at birth) infants who were hospitalized in the Shree Krishna Hospital NICU
* Performed Kangaroo Care during their infant's hospitalization
* Live in a village that is "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital
* At least 18 years old
* Speak Gujarati
Healthcare Providers- Physicians:
* Physicians and nurses who work in either the Shree Krishna Hospital NICU or in community settings within a 50-kilometer radius who provide newborn care to at least 3 newborns each week
* At least 18 years old
* Speak Gujarati
Village Health Workers:
* Village health workers who operate in one of the "adopted" villages within a 50-kilometer radius of Shree Krishna Hospital
* We will aim to recruit one health worker from 10 of the 15 subregions of the district of Anand, based on geography
* At least 18 years old
* Speak Gujarati
AIM 2
Mothers:
* Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
* Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge
* Speaks Gujarati
* At least 18 years old
AIM 3
Mothers:
* Mothers of an infant born with low birthweight (\< 2500g) who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
* Must reside in a village "adopted" by and within a 50-kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge
* Speaks Gujarati
* At least 18 years old
Exclusion Criteria (applicable to all aims)
* Persons unable to provide informed consent
* Pregnant women may enroll in this study, though, we will not be intentionally recruiting pregnant women. (Refer to section 18 for more information on this)
* Prisoners will not be included in the study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07231432
Study Brief:
Protocol Section:
NCT07231432