Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation (NCT00531102) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Establishing Functional Residual Capacity During Newborn Resuscitation on Oxygenation
Stopped: Slow enrolment
Canada40 participantsStarted 2008-02
Plain-language summary
Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort. Resuscitating infants with continuous positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than providing FFO2 because of its ability to establish functional residual capacity in the lungs. Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35 weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at five minutes of age compared to infants resuscitated with the 50% FFO2.
Who can participate
Age range
1 Minute
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
. Inborn
. ≥35 weeks gestational age
. Neonatal resuscitation team present at delivery
. Central cyanosis despite 60 seconds of spontaneous respirations in room air. Sustained respirations are defined as: spontaneous breathing that is regular in rhythm and sufficient to maintain a heart rate ≥100 beats per minute such that provision of artificial tidal volume breathing is not required.
Exclusion criteria
. Lethal anomalies
. Cyanotic congenital heart disease
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
The primary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥80%. To be considered stable, the oxygen saturation must remain at or above the predetermined target saturation for at least 30 seconds.