Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00637169
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2008-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canadian Oxygen Trial (COT)
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants: The Canadian Oxygen Trial (COT)
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COT
Brief 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?
Detailed Description:
Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MCT-79217/ISRCTN62491227 | None | None | View |