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

Development of Control of Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573053
• Other study ID #: B2007:157
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 11, 2007
• Last updated: April 18, 2011
• Start date: November 2007
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 70 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Development of Control of Breathing
• Respiratory Aspiration

Intervention

Other:
• Oxygen saturation range
Maintain functional oxygen saturation range between 91 and 95%
• Oxygen saturation range
Maintain functional arterial oxygen saturations in the range of 85- 89%

Locations

Country	Name	City	State
Canada	Health Science Centre	Winnipeg	Manitoba
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants		3 months	Yes
Secondary	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	Yes