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OpenTrials
Completed

NCT Number: NCT00845624

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

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.

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants <1500 grams or <32 weeks gestation

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Retinopathy of prematurity

    Time frame: 4 weeks to 52 weeks of life

Secondary outcomes

  1. Time outside targeted saturation range

    Time frame: entire hospitalization

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

DURATION OF TIME OUTSIDE, BELOW, AND ABOVE THE TARGETED Oxygen SATURATION RANGE In Preterm Infants

Acronym: SAT01ROP

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 18, 2009
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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