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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT06279169
Eligibility Criteria:
Inclusion Criteria:
* Gestational age of 38-41 weeks,
* Newborn birth weight \>2500 g
* Stable vital signs before the procedure,
* Postanatal age between 2-28 days,
* No contraindications to the administration of hepatitis B vaccine
* Delivery of the newborn to the mother after birth
* Consent of the parents of the newborn to participate in the study
* Fasting less than 3 hours/30 minutes before feeding
* A valid score on the newborn hearing screening test
* Newborn not crying before vaccination
Exclusion Criteria:
* Newborn babies requiring respiratory support,
* Newborns with any neurological disorder (seizures)
* Newborns taking opiates or born to mothers taking opiates
* Newborns receiving muscle relaxants, sedatives, analgesics
* Babies with major congenital anomalies
* Neonates with an APGAR score of less than 7 at 5 minutes
* Neonates who have undergone surgery
* Newborns with birth trauma (especially rapid delivery)
* Conditions that may prevent communication with parents (e.g. speech problem)
* Hearing impairment
* Newborns who will be transferred to another hospital
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
28 Days
Study:
NCT06279169
Study Brief:
Protocol Section:
NCT06279169