Canadian Oxygen Trial (COT)

McMaster University

Status and phase: Completed; Phase 3

Conditions: Respiratory Insufficiency of Prematurity

Treatments: Other: Titration of oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00637169

NTG-2006-COT

MCT-79217/ISRCTN62491227

Details and patient eligibility

About

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?

Full 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.

Enrollment: 1,201 patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age 23 0/7 - 27 6/7 weeks
• Postnatal age < 24 hours

Exclusion criteria

• Infant not considered viable (decision made not to administer effective therapies)
• Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
• Known or strongly suspected cyanotic heart disease
• Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
• Unlikely to be available for long-term follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,201 participants in 2 patient groups

1

Experimental group

Description:

Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.

Treatment:

Other: Titration of oxygen therapy

2

Active Comparator group

Description:

Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 91-95%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.

Treatment:

Other: Titration of oxygen therapy