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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT06593808
Eligibility Criteria:
Inclusion Criteria:
* Infants with birth weight less than 1400 grams in incubator who have reached a minimum weight of 1400 grams
* Stable clinical condition: normal heart rate and respiratory rate, No need for invasive respiratory assistance, no episodes of apnea, stable axillary temperature not less than 36.5°for at least 72 hours.
* No need for phototherapy
* Stable or increasing weight for at least 48 hours
* Signature by both parents of an informed consent
Exclusion Criteria:
* Severe congenital anomalies at birth
* Need for invasive respiratory support at the time of enrollment
* Ongoing phototherapy
* Major surgical pathology with need for surgery
* Failure by both parents to sign up for informed consent
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06593808
Study Brief:
Protocol Section:
NCT06593808