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

Study Overview
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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

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

Conditions
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Development of Control of Breathing

Intervention / Treatment
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* Other: Oxygen saturation range
* Other: Oxygen saturation range


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 70 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High<br>Arterial oxygen saturations in the range of 91-95% | Other: Oxygen saturation range<br>* Maintain functional oxygen saturation range between 91 and 95%<br>|
| Experimental: Low<br>Arterial oxygen saturations in the range of 85-89% | Other: Oxygen saturation range<br>* Maintain functional arterial oxygen saturations in the range of 85- 89%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs