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Canadian Oxygen Trial (COT)

NCT00637169 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1201

Last updated 2018-03-22

No results posted yet for this study

Summary

Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?

Conditions

  • Respiratory Insufficiency of Prematurity

Interventions

OTHER

Titration of oxygen therapy

Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McMaster University

    lead OTHER

Principal Investigators

  • Barbara Schmidt, MD · McMaster University

  • Robin Roberts, MMath · Hamilton Health Sciences/McMaster University

  • Elizabeth Asztalos, MD · Sunnybrook Health Sciences Centre

  • Alfonso Solimano, MD · Children's & Women's Health Centre of BC

  • Robin Whyte, MD · IWK Health Centre

  • Jack Rabi, MD · Foothills Hospital

  • Christian Poets, MD · University Children's Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States
  • Argentina
  • Canada
  • Finland
  • Germany
  • Israel

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 NCT00637169 on ClinicalTrials.gov