CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure (NCT03670732) | Clinical Trial Compass
TerminatedNot Applicable
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
Stopped: Unable to obtain needed equipment and COVID-related suspension of clinical research
United States52 participantsStarted 2017-09-30
Plain-language summary
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.
Who can participate
Age range
6 Months
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 23-34 completed weeks
* Stable on non- invasive respiratory support for at least 24h
* CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O
* FiO2 requirement of \<0.40
Exclusion Criteria:
* Clinical instability as judged by the clinical team
* FiO2 requirement of \> 0.40 for more than 60 min.
* \>10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.
* Anticipated intubation within next 24 h.
* Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).
* Hemodynamically significant patent ductus arteriosus (PDA)
* Anticipated weaning off non-invasive support in the next 24 h.
* Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias
* Lack of study equipment or personnel
* Lack of parental consent
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.