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Completed

NCT Number: NCT00637169

Canadian Oxygen Trial (COT)

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?

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Key information

Conditions

Respiratory Insufficiency of Prematurity Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network, Buenos Aires, Argentina

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Titration of oxygen therapy

Other

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

Other names: Masimo Radical Pulse Oximeter

Primary outcomes

  1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)

    Time frame: 18-21 months corrected for prematurity

Secondary outcomes

  1. Retinopathy of prematurity

    Time frame: 32 to 44 weeks postmenstrual age

  2. Bronchopulmonary dysplasia

    Time frame: 36 weeks postmenstrual age

  3. Brain injury

    Time frame: from week one of life up to 36 weeks postmenstrual age

  4. Patent ductus arteriosus

    Time frame: until first discharge home

  5. Necrotizing enterocolitis

    Time frame: until first discharge home

  6. Growth

    Time frame: until 18-21 months corrected for prematurity

  7. respiratory morbidity

    Time frame: until 18-21 months corrected for prematurity

  8. Mean developmental index scores on the Bayley Scales

    Time frame: 18-21 months corrected for prematurity

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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)

Acronym: COT

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 17, 2008
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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