NHFOV Vs NIPPV Post-extubation in Preterm Neonates (NCT06620107) | Clinical Trial Compass
CompletedNot Applicable
NHFOV Vs NIPPV Post-extubation in Preterm Neonates
Egypt80 participantsStarted 2023-01-20
Plain-language summary
comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Preterm neonates with gestational age between 32 and 36 weeks and on mechanical ventilation ready to be extubated.
When the case is ready for extubation , will receive at least one loading dose of caffeine citrate (20 mg/kg/dose) and daily maintenance dose of 5 mg/kg/dose.
Criteria for extubation:
* Blood gas analysis: PH \> 7.25 and PaCO2 ≤ 60 mmHg.
* Airway pressure (Paw) of 7 to 8 cmH2O.
* Required fraction of inspired oxygen (FiO2) ≤ 30%.
* Sufficient spontaneous breathing by clinical evaluation.
Exclusion Criteria:
* Full term neonates.
* Preterm neonates who will not require intubation.
* Preterm neonates with one of the following criteria:
birth weight \> 900 gms , major congenital anomalies, upper airway anomalies, neuromuscular diseases, surgical cases, intraventricular hemorrhage grade IV.
• Cases that require reintubation after more than 72 hours of extubation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
reintubation and the duration of respiratory support
Timeframe: from the date of birth till the date of discharge from NICU or death (assessed up to 3 months)..