Infant Oxygen Study Did Not Disclose Risks
The ethics of a premature infant oxygen study have recently been called into question. The Department of Health and Human Services (HHS) sent a letter in March to the University of Alabama, which was the lead site in the SUPPORT study. One of the purposes of this trial was to learn the appropriate and ideal threshold of oxygen that should be given to low birth weight infants.
SUPPORT Trial Consent Letter did not Spell out Risks
The HHS noted that previous research has shown a relationship between higher oxygen levels and eye disease such as retinopathy of prematurity (ROP) which often leads to blindness. Previous studies have also shown a relationship between lower oxygen levels and death. However, according to the letter the consent form used did not adequately disclose possible risks to babies.
“For many of those infants, the level of oxygen they received was different from what they would have received had they not participated in the study.”
Lisa R. Buchanan, MAOM, Compliance Oversight Coordinator
SUPPORT Study Details
- 1,316 infants (24 to 28 weeks gestation) participated between 2004 and 2009.
- Of the babies participating, 130 died and 91 developed a serious eye disease.
- 23 academic institutions took part but The University of Alabama at Birmingham was the lead site in the study. Others included Stanford, Yale, and Duke.
- Oxygen was not measured by absolute quantity but instead by the saturation in the infant’s blood (SpO2).
- Infants were randomly assigned to either the lower (85-89% SpO2) or higher (90-91% SpO2) ranges of oxygen.
- Normal oxygen range is 85% to 95%.
- To measure these, researchers used a pulse oximeter which was applied to the foot or hand.
- The New England Journal of Medicine published the SUPPORT study in 2010.
SUPPORT Trial Findings
- The results from the SUPPORT Study echoed previous research.
- Out of the low oxygen group only 41 out of 475 (8.6%) developed sever ROP compared to the 91 out of 509 (17.9%) in the higher oxygen group.
- Alternatively, the low oxygen group had a higher percentage of deaths with 130 out of 654 (19.9%) infants dying before discharge.
- This was compared to 107 out of 662 who died in the high oxygen group (16.2%)
- Thus, it appeared that although the lower group produced less ROP it was at the cost of fewer babies surviving.
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If your child was injured in the SUPPORT clinical trial, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.