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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT04068558
Eligibility Criteria:
Inclusion criteria:
* Premature infants born before 28 weeks of gestation
* Corrected age below 32 weeks of gestation
* Postnatal age \> or = 3 days
* Receiving NIPPV (any mode)
* Equipped with an Edi catheter
* Receiving caffein treatment
* Parental consent
* Recipient of French social security coverage
Non-inclusion criteria:
* More than 1 apnea/hour requiring bag-mask ventilation, or pH\<7.2 and/or TcPCO2\>70, or FiO2\>0.6 in the previous 6 hours.
* Nasal trauma precluding the use of non-invasive ventilation
* Major congenital anomalies
* Grade III or higher intraventricular hemorrhage
* Use of anesthetics or sedative within the past 24 hours, except opioids for iatrogenic withdrawal treatment
* Hemodynamic compromise defined as a mean blood pressure less than gestational age (in mmHg) or a capillary refill time more than 3 seconds
* Neuro-muscular disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Study:
NCT04068558
Study Brief:
Protocol Section:
NCT04068558