Which noninvasive breathing support is better after removing a newborn’s breathing tube?
Official title: Effectiveness of Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation as Post Extubation Respiratory Support in Neonates Born At ≥ 26 Weeks' Gestation: A Randomized Clinical Trial
Run by Aga Khan University · NCT07836166 · Data updated 2026-11-12
This trial tests if noninvasive high frequency oscillatory ventilation (nHFOV) works better than nasal intermittent mandatory ventilation (NIMV) for babies born at 26 weeks or later after their breathing tube is removed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 18 Weeks |
| Sex | All |
| Enrollment | 172 (estimated) |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Status | Recruiting |
| Started | October 13, 2026 |
| Main results expected | October 13, 2028 |
| Study ends | April 13, 2029 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07836166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are newborns born at 26 weeks of gestation or later who have been intubated for at least 24 hours and are undergoing their first planned extubation.
✕Probably not a fit
Newborns who do not meet extubation readiness criteria or have exclusion conditions may not benefit from the interventions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study is a prospective, single-center, open-label randomized trial comparing two noninvasive breathing support methods after planned extubation in neonates. Participants are assigned 1:1 to receive either nHFOV or NIMV based on gestational age stratification, with allocation concealed until consent. The main goal is to see if nHFOV reduces the need to reintubate within 72 hours and to compare safety and other respiratory and clinical outcomes. Blinding of clinicians is not possible due to different ventilator settings, but predefined criteria will guide decisions to limit bias. The study aims to generate evidence on which noninvasive approach facilitates safer extubation in this high-risk population.
Why it matters
Potential benefit: If successful, the study could identify a breathing support that reduces extubation failures and shortens hospital stays for very preterm or late preterm newborns.
How similar studies have gone: There is limited direct comparison between nHFOV and NIMV in this specific setting, making this trial relatively novel and potentially clinically informative.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age at birth ≥26 weeks (inborn or outborn) * Postmenstrual age \<44 weeks at enrollment according to NICU AKUH admission criteria * Intubation for respiratory distress or respiratory failure * Intubated for ≥24 hours * Undergoing first planned extubation * Meets prespecified extubation readiness criteria * Written informed consent from a parent or legal guardian Exclusion Criteria * Birth weight \<500 g * Major congenital anomaly affecting cardiac or respiratory function * Upper airway anomaly * Neuromuscular disorder affecting respiration * Requirement for surgical intervention during the study period * Grade IV intraventricular hemorrhage diagnosed before randomization * Intubation solely for an elective procedure in an otherwise healthy neonate previously breathing room air
Where it's running
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Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan
Karachi, Sindh, Pakistan Recruiting
Study contacts
- Principal investigator: Ali S Hussain, FCPS Paediatrics, Neonatology — Aga Khan University
- Study coordinator: Hafsah Naz, fellow Paediatric Neonatology
- Email: hafsah.naz@aku.edu
- Phone: +92 21 33103390
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.