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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845624
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : June 15, 2012
Medtronic - MITG
Information provided by (Responsible Party):
David A Kaufman, University of Virginia

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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Preterm infants <1500 grams or 32 weeks gestation.

Primary Outcome Measures :
  1. Retinopathy of prematurity [ Time Frame: 4 weeks to 52 weeks of life ]

Secondary Outcome Measures :
  1. Time outside targeted saturation range [ Time Frame: entire hospitalization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
NICU patients at risk for ROP

Inclusion Criteria:

  • Preterm infants <1500 grams or <32 weeks gestation

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00845624

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United States, Virginia
University of Virginia Neonatal Intensive Care Unit
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Medtronic - MITG
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Principal Investigator: David Kaufman, MD University of Virginia

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David A Kaufman, MD, University of Virginia Identifier: NCT00845624     History of Changes
Other Study ID Numbers: 12213
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: February 2009

Keywords provided by David A Kaufman, University of Virginia:
oxygen saturation
retinopathy of prematurity
long term outcomes

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases