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

Phase 2

Completed

• Conditions: Development of Control of Breathing
• Interventions: Other: Oxygen saturation range

• Registration Number: NCT00573053
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-04-18
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low	Oxygen saturation range	Arterial oxygen saturations in the range of 85-89%
High	Oxygen saturation range	Arterial oxygen saturations in the range of 91-95%

Primary Outcome Measures

Name	Time	Method
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

St. Boniface General Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Health Science Centre; 🇨🇦 Winnipeg, Manitoba, Canada