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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT04099602
Eligibility Criteria:
Inclusion Criteria:
* families being voluntary to participate in the study
* infants being born between 32 and 37 weeks plus 6 days of gestation
* infants having a birth weight of ≥1500 g
* infants having a fifth-minute Apgar score of more than seven
* infant's bilirubin level is not sufficient to require phototherapy
* the vital signs of the baby are within normal limits
* the absence of congenital major malformation of the infants
* the lack of patent ductus arteriosus requiring treatment
* no proven sepsis diagnosis
Exclusion Criteria:
* neonates with disease disrupting skin integrity (epidermolysis bullosa, ichthyosis, collodion baby)
* need for phototherapy
* infants with gastrointestinal obstruction and biliary atresia
* infants with congenital major deformations
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
32 Weeks
Maximum Age:
38 Months
Study:
NCT04099602
Study Brief:
Protocol Section:
NCT04099602