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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00573053

Enrollment

Registered

2007-12-13

Start date

2007-11-30

Completion date

2011-01-31

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Control of Breathing

Keywords

hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs

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

Interventions

OTHEROxygen saturation range

Maintain functional oxygen saturation range between 91 and 95%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Days to 70 Days

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.

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026