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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05079594
Eligibility Criteria:
Inclusion Criteria:
1. Newborns whose postnatal age is between 1-5 days,
2. 38-42. newborns born between gestational weeks,
3. Healthy newborns,
4. Babies of mothers without diabetes,
5. Newborns who were not given any opioid and non-opioid drugs before the application,
6. Newborns who have been fed at least 30 minutes ago,
7. Newborns without any painful interventions other than vitamin K and Hepatitis B injections will be included.
8. Mothers who can speak and understand Turkish,
9. The mothers and their babies who accepted to participate in the study and whose written consent form was obtained from them will be included in the study.
Exclusion Criteria:
1. Connected to a mechanical ventilator,
2. Having a neurological disorder,
3. Congenital anomaly,
4. Having hyperglycemia,
5. Having undergone a surgical procedure,
6. Substance addicted mother and her baby,
7. If the lancet cannot be inserted and removed at once, the baby will be excluded from the study.
8. Infants, despite meeting the criteria, will be excluded from the study if the heel blood collection takes more than 2 minutes in total, the procedure is disrupted by someone entering the room loudly, or the mother changes the position of the baby.
9. Mothers with a special condition that will cause difficulties in understanding and perception will be excluded from the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
1 Month
Study:
NCT05079594
Study Brief:
Protocol Section:
NCT05079594