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

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ClinicalTrials.gov Identifier: NCT00573053
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
University of Manitoba

Brief Summary:
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 or disease Intervention/treatment Phase
Development of Control of Breathing Other: Oxygen saturation range Phase 2 Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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%



Primary Outcome Measures :
  1. Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   up to 70 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573053


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

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
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: January 2011

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
Pathologic Processes