Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants
Stopped early · Not applicable
Conditions studied: Extreme Prematurity - Less Than 28 Weeks
In brief
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.
Key facts
- Study ID
- NCT01773746
- Run by
- Sharp HealthCare
- People needed
- 80
- Starts
- 2013-08-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2018-09-12
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants with a gestational age of 23 0/7 to 28 6/7 weeks by best obstetrical estimate.
- Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation Infants whose parents/legal guardians have provided consent for enrollment, or for whom a waiver of consent is in place Infants without known major congenital malformations prior to delivery
You may not qualify if…
- Any infant transported to the center after delivery Infants whose parents/legal guardians refuse consent Infants born when the research apparatus/study personnel are not available Infants < 23 weeks 0 days or > 28 weeks 6 days, completed weeks of gestation
Where it is running
- Sharp Mary Birch Hospital for Women and Newborns — San Diego, California, United States
- Connecticut Children's Medical Center — Farmington, Connecticut, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Oklahoma University Health Sciences Center — Oklahoma City, Oklahoma, United States
- OU - Tulsa - Saint Francis Hospital — Tulsa, Oklahoma, United States
- Innsbruck Medical University — Innsbruck, Austria
- Medical University of Vienna — Vienna, Austria
- Chu-Toulouse — Toulouse, France
- Ulm University — Ulm, Germany
- National Maternity Hospital — Dublin, Ireland
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy
- University of Siena — Siena, Italy
- Poznan University of Medical Sciences — Poznan, Poland
- St. Petersberg State Pediatric Medical University — Saint Petersberg, Russia
- University Medical Center Ljubljana — Ljubljana, Slovenia
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital Saint Joan de Deu — Barcelona, Spain
- Hospital Clinico San Carlos — Madrid, Spain
- Hospital La Fe — Valencia, Spain
- Karolinska Institutet — Stockholm, Sweden
- James Cook University Hospital — Middlesbrough, United Kingdom
Full record on ClinicalTrials.gov
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