NCT00637169

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?

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,201

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_3

Geographic Reach
6 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 22, 2018

Status Verified

December 1, 2014

Enrollment Period

5.8 years

First QC Date

March 6, 2008

Last Update Submit

March 20, 2018

Conditions

Respiratory Insufficiency of Prematurity

Keywords

oxygen therapyneurodevelopmental impairment

Outcome Measures

Primary Outcomes (1)

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

    18-21 months corrected for prematurity

Secondary Outcomes (8)

  • Retinopathy of prematurity

    32 to 44 weeks postmenstrual age

  • Bronchopulmonary dysplasia

    36 weeks postmenstrual age

  • Brain injury

    from week one of life up to 36 weeks postmenstrual age

  • Patent ductus arteriosus

    until first discharge home

  • Necrotizing enterocolitis

    until first discharge home

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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.

Other: Titration of oxygen therapy

2

ACTIVE COMPARATOR

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.

Other: Titration of oxygen therapy

Interventions

Titration of oxygen therapyOTHER

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

Also known as: Masimo Radical Pulse Oximeter
12

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Stony Brook University Medical Center

Stony Brook, New York, 11794-8111, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19035, United States

Location

Hospital of the University of Pennsylvania (HUP)

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network

Buenos Aires, Argentina

Location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

B.C. Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R3E 0L8, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, Manitoba, R3L 0L8, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3P 1R8, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital of Eastern Ontario and Ottawa General Hospital

Ottawa, Ontario, K1H 8L1, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5S 1B2, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

CHU Ste. Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1L 3L5, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Oulu University Central Hospital

Oulu, Finland

Location

University Children's Hospital

Tübingen, Germany

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Bnai-Zion Medical Center

Haifa, 31048, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Related Publications (3)

  • Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, Solimano A, Roberts RS; Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial. JAMA. 2013 May 22;309(20):2111-20. doi: 10.1001/jama.2013.5555.

    PMID: 23644995RESULT

  • Schmidt B, Roberts RS, Whyte RK, Asztalos EV, Poets C, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Group. Impact of study oximeter masking algorithm on titration of oxygen therapy in the Canadian oxygen trial. J Pediatr. 2014 Oct;165(4):666-71.e2. doi: 10.1016/j.jpeds.2014.05.028. Epub 2014 Jun 25.

    PMID: 24973289RESULT

  • Jensen EA, Whyte RK, Schmidt B, Bassler D, Vain NE, Roberts RS; Canadian Oxygen Trial Investigators. Association between Intermittent Hypoxemia and Severe Bronchopulmonary Dysplasia in Preterm Infants. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1192-1199. doi: 10.1164/rccm.202105-1150OC.

    PMID: 34428130DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Barbara Schmidt, MD

    McMaster University

    STUDY CHAIR

  • Robin Roberts, MMath

    Hamilton Health Sciences/McMaster University

    PRINCIPAL INVESTIGATOR

  • Elizabeth Asztalos, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Alfonso Solimano, MD

    Children's & Women's Health Centre of BC

    PRINCIPAL INVESTIGATOR

  • Robin Whyte, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

  • Jack Rabi, MD

    Foothills Hospital

    PRINCIPAL INVESTIGATOR

  • Christian Poets, MD

    University Children's Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2008

First Posted

March 17, 2008

Study Start

December 1, 2006

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

March 22, 2018

Record last verified: 2014-12

Locations

IL(3)CA(14)AR(1)US(3)FI(1)DE(1)