Clinical trial NCT00845624: Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants
Official title: DURATION OF TIME OUTSIDE, BELOW, AND ABOVE THE TARGETED Oxygen SATURATION RANGE In Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinopathy of Prematurity
Keywords: oxygen saturation
retinopathy of prematurity
long term outcomes
hypoxia
hyperoxia
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2009-02-18
Enrollment: 102
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NICU patients at risk for ROP

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants \<1500 grams or \<32 weeks gestation

Exclusion Criteria:

* None

Primary outcomes:
measure: Retinopathy of prematurity
timeFrame: 4 weeks to 52 weeks of life
Secondary outcomes:
measure: Time outside targeted saturation range
timeFrame: entire hospitalization
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Neonatal Intensive Care Unit
state: Virginia
Study officials:
affiliation: University of Virginia
name: David Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaufman DA, Cuff AL, Wamstad JB, Boyle R, Gurka MJ, Grossman LB, Patrick P. Fluconazole prophylaxis in extremely low birth weight infants and neurodevelopmental outcomes and quality of life at 8 to 10 years of age. J Pediatr. 2011 May;158(5):759-765.e1. doi: 10.1016/j.jpeds.2010.11.002. Epub 2010 Dec 18.