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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT03629093
Eligibility Criteria:
Inclusion Criteria:
* Apgar score ≥ 8 at birth
* ASA level Ⅰ\~Ⅲ
* Obtained written consent form from the infants' parents or guardians
Exclusion Criteria:
* Postmenstrual age ≤ 44 weeks, or postmenstrual age ≥ 144 weeks
* Severe cardiac, pulmonary, or neurologic disease
* Severe obstructive sleep apnea hypopnea syndrome
* History of dystocia and/or hypoxic ischemic encephalopathy
* Gestational age at birth ≤32 weeks
* Any known or suspected chromosomal abnormalities, abnormal development of vision or hearing, neurodevelopment retardation, or other known acquired or congenital abnormalities that might affect neurodevelopment
* Significant cardiovascular surgery, significant ENT surgery, or neurosurgery
* Malignant diseases that may reduce survival
* Taking part in other clinical trials in the last 3 months or at present
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Weeks
Maximum Age:
2 Years
Study:
NCT03629093
Study Brief:
Protocol Section:
NCT03629093