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 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT02480205
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants, \>26 0/7 and \< 34 weeks GA, at least 3 days old and younger than 1 month,
* on NIPPV with settings in the range : Maximal inspiratory pressure (total, including PEEP) \< 20 cmH2O, and PEEP : 5-7 cmH2O,
* with FiO2 \<40%, and stable.
Exclusion Criteria:
* Suspected or proven pneumothorax
* Patient on high-flow nasal cannula or nasal continuous positive airway pressure (nCPAP)
* Infants with severe recurring apnea
* Recent worsening of respiratory status with increase work of breathing, recent increase in FiO2, or linked with a suspected sepsis
* Contraindications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions)
* Hemodynamic instability requiring inotropes.
* Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 \> 45%, or PaCO2 \> 65 mmHg on blood gas in the last hour.
* Patient for whom a limitation of life support treatments is discussed or decided.
* Refusal by the treating physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Days
Maximum Age:
1 Month
Study:
NCT02480205
Study Brief:
Protocol Section:
NCT02480205