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

NCT ID: NCT00573053

Last Updated: 2011-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-01-31

Brief Summary

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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

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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

Conditions

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Development of Control of Breathing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High

Arterial oxygen saturations in the range of 91-95%

Group Type ACTIVE_COMPARATOR

Oxygen saturation range

Intervention Type OTHER

Maintain functional oxygen saturation range between 91 and 95%

Low

Arterial oxygen saturations in the range of 85-89%

Group Type EXPERIMENTAL

Oxygen saturation range

Intervention Type OTHER

Maintain functional arterial oxygen saturations in the range of 85- 89%

Interventions

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Oxygen saturation range

Maintain functional oxygen saturation range between 91 and 95%

Intervention Type OTHER

Oxygen saturation range

Maintain functional arterial oxygen saturations in the range of 85- 89%

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Days

Maximum Eligible Age

70 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Principal Investigators

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Ruben E Alvaro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Health Science Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2007:157

Identifier Type: -

Identifier Source: org_study_id

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