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Case study

 

The SUPPORT pulse oximetry trial (6–11)


The Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) was a multi-centre study involving 1316 extremely preterm babies (< 28 weeks gestation) in the United States.

The first part of the study compared two different ways of ventilating preterm babies immediately after birth. In the second part of the study (the Pulse Oximetry Trial), the same babies were maintained at two different ranges of target oxygen saturation levels in the Neonatal Intensive Care Unit (NICU).

The Pulse Oximetry Trial sparked ethical debates when lawsuits were filed against the ethics committee and principle investigator of the lead study site.  Among the claims was failure to obtain fully informed consent (Lantos, 2015).

 

Brief background to the Pulse Oximetry Trial

When babies are born prematurely, their lungs have not developed enough to function properly. Many of them need extra oxygen to help them breathe. Without sufficient oxygen, these babies could suffer from brain damage and may die. However, the risk of providing too much oxygen was retinopathy, an eye condition that could lead to blindness.

When the SUPPORT trial was conceived in 2004, preterm babies in the U.S. were given oxygen to maintain their blood oxygen saturation levels in the standard range of 85 – 95%. However, retinopathy ‘remained a significant cause of morbidity among preterm babies’ (SUPPORT protocol, 2004).

The researchers wanted to find out whether narrowing the target oxygen saturation level down to 85 – 89% would decrease the incidence of severe retinopathy without causing additional harm, compared to the higher range of 91 – 95%. Both ranges were within the range used in standard care.

The trial was double-blinded by using a special pulse oximeter that displayed babies’ oxygen saturation levels three percentage points higher in the low target range group, and three percentage points lower in the high target range group. As such, all infants were maintained between an apparent range of 88 – 92%.  

The full research protocol can be accessed here.

 

SUPPORT Study Group. Target Ranges of Oxygen Saturation in Extremely Preterm Infants. New England Journal of Medicine. 2010 May 27;362(21):1959–69. Available from: https://doi.org/10.1056/NEJMoa0911781

SUPPORT Study Group. Protocol: The SUrfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (The SUPPORT Trial) [Internet]. The Eunice Kennedy Shriver NICHD Neonatal Research Network; 2004 [cited 2019 Jan 16]. Available from: https://www.nih.gov/sites/default/files/institutes/foia/support-protocol.pdf

Carlo W, Ambalavanan N. Participant information sheet: The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants [Internet]. National Institute of Child Health and Development (NICHD); 2014 [cited 2019 Jan 16]. Available from: https://www.nichd.nih.gov/sites/default/files/about/Documents/2013-04-08_All_Consent_SUPPORT.pdf#search=SUPPORT-trial

Lantos JD. Vindication for SUPPORT. New England Journal of Medicine. 2015 Oct 8;373(15):1393–5. Available from: https://doi.org/10.1056/NEJMp1510876

Furlow B. SUPPORT controversy’s lessons for informed consent. The Lancet Respiratory Medicine. 2015 Dec 1;3(12):928–9. Available from: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(15)00417-8/abstract

United States District Court for Northern District of Alabama. Looney v. Moore, Case No.: 2:13-cv -00733-KOB [Internet]. 2014. Available from: https://www.govinfo.gov/content/pkg/USCOURTS-alnd-2_13-cv-00733/pdf/USCOURTS-alnd-2_13-cv-00733-0.pdf

Activity:

1. Read the participation information sheet of the SUPPORT trial.* (10 to 15-minute read) 

*  This is a large file containing all versions of the PIS. It is enough to just read the first one.

2. Can you spot anything that might have led to the allegation that parents were not fully informed about the second part of the study (the pulse oximetry trial)?