MONITOR - Version 3 - 27 Nov 17
Research type
Research Study
Full title
Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges
IRAS ID
194632
Contact name
Rod Kelly
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
We aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes.
We are still learning what levels of oxygen premature babies need – both too little or too much oxygen in the first weeks after birth may be harmful. Previous studies used saturation monitoring (SpO2), where a small probe shines light through the skin and calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2 range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting oxygen higher increased the number of infants who needed treatment for an eye condition called retinopathy of prematurity (ROP).
It is possible an SpO2 range higher than 91-95% would be associated with even better survival. It is also possible that a higher range might not improve survival but could increase the need for ROP treatment.
Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.
Based on previous research we are confident these oxygen levels will not be dangerously high. To provide an additional measure of oxygen we will also use a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and measures oxygen and carbon dioxide levels on the skin surface.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
18/ES/0006
Date of REC Opinion
9 Mar 2018
REC opinion
Further Information Favourable Opinion