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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT03242057
Eligibility Criteria:
Inclusion Criteria:
1. Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
2. Postnatal age ≤ 14 days
3. Inborn
4. Mechanically ventilated for at least 12 hrs.
5. Intubated within first 24 hrs. after birth
6. Outborn infants intubated and transferred to UF within 24 hrs. after birth.
Exclusion Criteria:
1. Outborn \> 24hrs of age.
2. Failed elective extubation prior to study enrollment
3. Major congenital anomalies or known/suspected chromosomal anomalies
4. Use of paralytics in previous 24 hrs.
5. Participation in another randomized interventional trial
6. Known or suspected phrenic nerve palsy or lesion
7. Known or suspected diaphragmatic lesion
8. Any contraindication to have a nasogastric or orogastric tube placement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
32 Weeks
Study:
NCT03242057
Study Brief:
Protocol Section:
NCT03242057