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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT06622161
Eligibility Criteria:
Inclusion Criteria:
Investigators will include premature babies (born before 37 weeks of pregnancy) who are on SLE 6000 ventilator, and require additional oxygen therapy or respiratory support due to respiratory dysfunction.
Preterm babies will be included in the study if they will meet all the following criteria:
* Receiving respiratory support via mechanical ventilation, either non-invasive or invasive
* Receiving supplemental oxygen at the time of inclusion
* Written informed parental consent
Exclusion Criteria:
* Major Congenital Anomalies such as neural tube defects, neuromuscular disorders, congenital heart diseases, syndromic babies, and so forth.
* Resuscitation and termination of mechanical ventilation during the study
* Withdrawal of parent consent
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
13 Weeks
Study:
NCT06622161
Study Brief:
Protocol Section:
NCT06622161