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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Development of Control of Breathing
 Other: Oxygen saturation range
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 26
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High
Arterial oxygen saturations in the range of 91-95%
 Other: Oxygen saturation range
Maintain functional oxygen saturation range between 91 and 95%
Experimental: Low
Arterial oxygen saturations in the range of 85-89%
 Other: Oxygen saturation range
Maintain functional arterial oxygen saturations in the range of 85- 89%

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 70 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573053

Locations
Canada, Manitoba
Health Science Centre
Winnipeg, Manitoba, Canada, R3E 0L8
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Ruben E Alvaro, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Ruben E. Alvaro, Associate Professor of Pediatrics, University of Manitoba, University of Manitoba
ClinicalTrials.gov Identifier: NCT00573053     History of Changes
Other Study ID Numbers: B2007:157
Study First Received: December 11, 2007
Last Updated: April 18, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Manitoba:
hypercapneic response
hyperoxic response
breathing pattern
periodic breathing
sighs

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013