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

NCT ID: NCT00845624

Last Updated: 2012-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Retinopathy of Prematurity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Preterm infants \<1500 grams or 32 weeks gestation.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Preterm infants <1500 grams or <32 weeks gestation

Exclusion Criteria

• None

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

David A Kaufman

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kaufman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21168853 (View on PubMed)

Other Identifiers

12213

Identifier Type: -

Identifier Source: org_study_id