MedTrace Logo

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

NCT01124331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4965

Last updated 2019-03-13

No results posted yet for this study

Summary

The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

Conditions

  • Infant, Premature, Diseases
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Infant, Newborn, Diseases
  • Infant, Very Low Birth Weight

Interventions

PROCEDURE

Higher oxygen saturation target range (91%-95%)

higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter

PROCEDURE

Lower oxygen saturation (85%-89%)

Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter

Sponsors & Collaborators

Principal Investigators

  • Lisa Askie · National Health and Medical Research Council, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124331 on ClinicalTrials.gov