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

Primary Purpose

Development of Control of Breathing

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Oxygen saturation range
Oxygen saturation range
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Development of Control of Breathing focused on measuring hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs

Eligibility Criteria

21 Days - 70 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Boniface General Hospital
  • Health Science Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High

Low

Arm Description

Arterial oxygen saturations in the range of 91-95%

Arterial oxygen saturations in the range of 85-89%

Outcomes

Primary Outcome Measures

Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants

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

Full Information

First Posted
December 11, 2007
Last Updated
April 18, 2011
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT00573053
Brief Title
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Official Title
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development of Control of Breathing
Keywords
hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High
Arm Type
Active Comparator
Arm Description
Arterial oxygen saturations in the range of 91-95%
Arm Title
Low
Arm Type
Experimental
Arm Description
Arterial oxygen saturations in the range of 85-89%
Intervention Type
Other
Intervention Name(s)
Oxygen saturation range
Intervention Description
Maintain functional oxygen saturation range between 91 and 95%
Intervention Type
Other
Intervention Name(s)
Oxygen saturation range
Intervention Description
Maintain functional arterial oxygen saturations in the range of 85- 89%
Primary Outcome Measure Information:
Title
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Days
Maximum Age & Unit of Time
70 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben E Alvaro, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Health Science Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0L8
Country
Canada

12. IPD Sharing Statement

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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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