Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00573053
First received: December 11, 2007
Last updated: April 18, 2011
Last verified: January 2011

December 11, 2007
April 18, 2011
November 2007
January 2011   (final data collection date for primary outcome measure)
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00573053 on ClinicalTrials.gov Archive Site
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.

To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:

i) The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Development of Control of Breathing
  • Other: Oxygen saturation range
    Maintain functional oxygen saturation range between 91 and 95%
  • Other: Oxygen saturation range
    Maintain functional arterial oxygen saturations in the range of 85- 89%
  • Active Comparator: High
    Arterial oxygen saturations in the range of 91-95%
    Intervention: Other: Oxygen saturation range
  • Experimental: Low
    Arterial oxygen saturations in the range of 85-89%
    Intervention: Other: Oxygen saturation range
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational age 23 0/7 - 27 6/7 weeks
  • Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
  • Postnatal age between 21 days and 70 days
  • Informed written consent obtained from at least one of the parents.

Exclusion Criteria:

  • Need for mechanical ventilation, NCPAP or O2
  • Sepsis or other known causes of apnea.
Both
up to 70 Days
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00573053
B2007:157
No
Ruben E. Alvaro, Associate Professor of Pediatrics, University of Manitoba, University of Manitoba
University of Manitoba
Not Provided
Principal Investigator: Ruben E Alvaro, MD University of Manitoba
University of Manitoba
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP