Time Outside Target Oxygen Saturation Range in Preterm Infants and Long Term Outcomes and Preterm Infants (SAT01ROP)

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
David A Kaufman, University of Virginia
ClinicalTrials.gov Identifier:
NCT00845624
First received: February 16, 2009
Last updated: June 13, 2012
Last verified: February 2009
  Purpose

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.


Condition
Retinopathy of Prematurity

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Retinopathy of prematurity [ Time Frame: 4 weeks to 52 weeks of life ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time outside targeted saturation range [ Time Frame: entire hospitalization ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Preterm infants <1500 grams or 32 weeks gestation.

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

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

NICU patients at risk for ROP

Criteria

Inclusion Criteria:

  • Preterm infants <1500 grams or <32 weeks gestation

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00845624

Locations
United States, Virginia
University of Virginia Neonatal Intensive Care Unit
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Covidien
Investigators
Principal Investigator: David Kaufman, MD University of Virginia
  More Information

No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David A Kaufman, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT00845624     History of Changes
Other Study ID Numbers: 12213
Study First Received: February 16, 2009
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
oxygen saturation
retinopathy of prematurity
long term outcomes
hypoxia
hyperoxia

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 16, 2014