NCT00845624

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 15, 2012

Status Verified

February 1, 2009

Enrollment Period

2.4 years

First QC Date

February 16, 2009

Last Update Submit

June 13, 2012

Conditions

Retinopathy of Prematurity

Keywords

oxygen saturationretinopathy of prematuritylong term outcomeshypoxiahyperoxia

Outcome Measures

Primary Outcomes (1)

  • Retinopathy of prematurity

    4 weeks to 52 weeks of life

Secondary Outcomes (1)

  • Time outside targeted saturation range

    entire hospitalization

Study Arms (1)

1

Preterm infants \<1500 grams or 32 weeks gestation.

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

NICU patients at risk for ROP

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Neonatal Intensive Care Unit

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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.

    PMID: 21168853DERIVED

MeSH Terms

Conditions

Retinopathy of PrematurityHypoxiaHyperoxia

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Kaufman, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 15, 2012

Record last verified: 2009-02

Locations

US(1)