Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight Infants
Completed · Not applicable
Conditions studied: Prematurity, Oxidant Injury
In brief
We propose a preliminary trial to evaluate the safety and efficacy of using more restricted oxygen during resuscitation for VLBW infants than is utilized currently in an effort to reduce the oxidant stress of such treatment, and to possibly reduce associated multi-system organ related dysfunction. In attempting to design a trial comparing higher versus lower oxygen during neonatal resuscitation with the potential for benefit to the enrolled infants, and a minimal level of risk, and acknowledging that the use of Room Air may be considered premature in view of the lack of any safety data in this population, we are proposing to utilize an oxygen blender and a pulse oximeter in the delivery room in the treated group. The treated group will have their fraction of inspired oxygen increased from 21%, as necessary, to achieve a target oxygen saturation of 85 to 90% at 5 minutes of life, compared with the standard of care group who will receive 100% oxygen without the use of a blender, which is the current approach in most centers in this country. The targeted saturation of 85% will provide enough oxygen to treat any ventilation/perfusion mismatch, while exposing the infants to significantly less inspired oxygen. Hypothesis: We hypothesize that the use of restricted inspired oxygen during resuscitation will result in a significant reduction in oxidant stress without any harmful clinical effects.
Key facts
- Study ID
- NCT00369720
- Run by
- Neil Finer
- People needed
- 40
- Starts
- 2005-01-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2019-10-04
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- inborn infant
- gestation 23 weeks to 31 weeks 6 days
You may not qualify if…
- known chromosomal or congenital anomalies
Where it is running
- University of California San Diego Medical Center — San Diego, California, United States
Full record on ClinicalTrials.gov
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