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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT05591651
Eligibility Criteria:
Inclusion Criteria:
* for mothers: a breastfeeding mother, living or residing in Osijek, with nipple skin damage (NTS 1, 2, 3, 4, or 5).
* for babies: newborns from a singleton pregnancy, of gestational age from 37 to 42 weeks, with a birth weight of 2,500 to 4,500 grams.
Exclusion Criteria:
* for mothers: mothers who do not breastfeed, mothers not living or residing in Osijek, mothers without nipple skin damage and mothers using other preparations for healing sore nipples (shells, pads).
* for children: visible anomalies in the newborn which may affect the breastfeeding process, newborns that required admission to the neonatal unit
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT05591651
Study Brief:
Protocol Section:
NCT05591651