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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04454502
Eligibility Criteria:
İnclusive criteria
* Newborn's body weight between 1001-1500gr
* Newborn being premature (\>28 and \< 32 GW)
* Being admitted to the neonatal intensive care unit within the first 24 hours after birth
* Absence of congenital anomaly (craniofacial abnormality such as cleft palate, cleft lip, paralysis of facial muscles) in the newborn
* Absence of any diagnosed gastrointestinal, neurological and genetic disease (necrotizing enterocolitis, third and fourth level intracranial hemorrhage (ICH), periventricular leukomalacia, hydrocephalus, down syndrome, omphalocele, gastroschisis, short bowel syndrome and other diseases) in the newborn
* Absence of congenital heart disease requiring surgical treatment in the newborn
* Absence of Oral feeding of the newborn (Nasogastric/orogastric or trophic feeding can be done)
* Non-contraindication of the mother's milk to her infant
* Absence of the mother's diagnosed psychiatric story
* Mother's openness to communication and cooperation
* Mother's volunteering to participate in the study
* Bringing sufficient colostrum for administration by the mother
* Mother being literate
* Mother being primiparous and having single infant
* Mother's age above 18 years Exclusive criteria
* Newborn being SGA and LGA
* Mother's not coming to breastfeed her infant between two breastfeeding follow-ups
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
28 Days
Study:
NCT04454502
Study Brief:
Protocol Section:
NCT04454502