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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT05797532
Eligibility Criteria:
Inclusion Criteria:
Newborns (0-28days);
* Being born at term (38 - 42 weeks)
* Stable vital signs
* Having completed the first 24 hours of life and being fed
* Heel blood procedure will be applied for the Ministry of Health screening.
* Not being breastfed 30 minutes before the procedure
* No previous invasive intervention other than vitamin K and hepatitis B vaccine.
* 1st and 5th minute Apgar score ≥7
* Parents have given written consent.
Exclusion Criteria:
Newborns (0-28days);
* Unstable vital signs
* Being bottle-fed or formula-fed
* Having a neurological diagnosis
* Prior exposure to another invasive procedure other than vitamin K and hepatitis B vaccine.
* Maternal use of opioids,
* Not being born at term.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Hours
Maximum Age:
36 Hours
Study:
NCT05797532
Study Brief:
Protocol Section:
NCT05797532