Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants (SAT01ROP)
The purpose of this study is to determine if there is a relationship between time spent out the targeted oxygen saturation range in preterm infants is associated with long-term outcomes such as Retinopathy of Prematurity.
Retinopathy of Prematurity
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||DURATION OF TIME OUTSIDE, BELOW, AND ABOVE THE TARGETED Oxygen SATURATION RANGE In Preterm Infants|
- Retinopathy of prematurity [ Time Frame: 4 weeks to 52 weeks of life ] [ Designated as safety issue: Yes ]
- Time outside targeted saturation range [ Time Frame: entire hospitalization ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Preterm infants <1500 grams or 32 weeks gestation.
All infants who had a birth weight of less than 1500 grams or less than 32 weeks gestation admitted to our neonatal intensive care unit (NICU) were eligible for the study. All infants were placed on Nellcor N600 pulsoximetry. Saturation data in two-second sampling from N600 OXIMAX pulse oximeters (Covidian, CA) was collected using a modified Nellcor® Oxinet® III system (Covidian, CA and Cardiopulmonary, Milford, CT) Alarm limits were set at 83% and 93% while infants required oxygen supplementation and 85% to 100% when neonates were in room air. Desaturation events were defined as number of times the saturation fell below the low saturation limit set on the monitor (83% if oxygen requirement >21%, 85% if patient on room air). High saturation events were defined as the number of times the patient's saturation was above the upper saturation limit (93% if oxygen requirement >21%)
The data collection system summarized each day in tabular form including average SPO2, number of low and high SPO2 events, duration of events in minutes, and the percentage of time infants spent outside of the intended saturation range. Primary outcome was threshold ROP requiring laser ablation. Data on ROP was collected during hospitalization and after discharge until resolution of ROP by pediatric ophthalmologist blinded to the study results. Secondary outcomes included bronchopulmonary dysplasia, length of hospitalization, sepsis, focal bowel perforation, necrotizing enterocolitis (stage 2 or greater), patent ductus ligation, intracranial hemorrhage, and number of red blood cell and platelet transfusions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845624
|United States, Virginia|
|University of Virginia Neonatal Intensive Care Unit|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||David Kaufman, MD||University of Virginia|