TerminatedNot Applicable

Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

Stopped: Slow recruitment

Germany6 participantsStarted 2015-01-01

Plain-language summary

To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Who can participate

Age range

5 Days – 28 Days

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: * Gestational age \<32+0 weeks * Birth weight \<1500 g * Received mechanical ventilation via an endotracheal tube for ≥120 h * Caffeine treatment according to unit guidelines * paCO2 \<65 mmHg with pH \>7.2 * FiO2 25-40% to maintain SpO2 at 90-94%. * Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O * Decision of the attending clinician to extubate Exclusion Criteria: * Major congenital malformation requiring surgery * Duct-dependent congenital heart disease * Neuromuscular disease * Participation in another randomized controlled trial * Death before reaching the eligibility criteria * Hydrocortisone treatment at the time of enrolment * Chronological age \>28 days

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

paCO2 at 72 h After Extubation

Timeframe: 64 h to 80 h

Trial details

NCT IDNCT02340299

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-31

Results submitted2019-05-06

View on ClinicalTrials.gov More Respiratory Distress Syndrome, Newborn trials