CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

This study has been completed.

Sponsor:

Collaborators:

Canadian Institutes of Health Research (CIHR)

The Children's Hospital Foundation of Manitoba

Information provided by:

University of Manitoba

ClinicalTrials.gov Identifier:

NCT01066728

First received: February 9, 2010

Last updated: March 1, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 9, 2010

Last Updated Date

March 1, 2010

Start Date ^ICMJE

August 2001

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01066728 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

Official Title ^ICMJE

Not Provided

Brief Summary

The objective of the present proposed study is to discover whether, in the nursery setting, administration of low concentration inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing more regular with less apneic time than that observed with administration of theophylline. The hypothesis to be tested is that inhalation of low concentration CO2 (0.8%) will reduce apnea more effectively and will have fewer adverse side effects than theophylline.

Detailed Description

To discover whether, in the nursery setting, continuous administration of a low concentration of inhaled CO2 (0.8%) for a prolonged period (3 days) can make breathing in preterm infants more regular with less apneic time than that observed with theophylline.
To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (>20 seconds), more effectively than theophylline.
To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Apnea of Prematurity

Intervention ^ICMJE

Other: CO2 inhalation
Inhalation of CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days
Drug: Theophylline

Study Arm (s)

Active Comparator: Theophylline
Oral loading dose of 6 mg per kilogram of body weight of theophylline followed by a maintenance dose of 2 mg per kilogram every 8 hours plus room air by nasal prongs at 0.5 l/min for 3 days.

Intervention: Drug: Theophylline
Experimental: CO2 inhalation
Equivalent loading and maintenance volume of oral normal saline plus CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days

Intervention: Other: CO2 inhalation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

September 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Infants between 27 and 32 weeks gestational age hospitalized in the neonatal intensive or intermediate care units
Significant apnea, defined as 5 or more self-resolved apneas, or 2 or more apneas requiring intervention over a 12 hr period

Exclusion Criteria:

Already on methylxanthine treatment
On supplemental oxygen, nasal continuous positive airway pressure (CPAP)
Had major congenital anomalies, sepsis, or other known causes of apnea

Gender

Both

Ages

27 Weeks to 32 Weeks

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT01066728

Other Study ID Numbers ^ICMJE

E98:242

Has Data Monitoring Committee

Yes

Responsible Party

Ruben E. Alvaro, MD, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of Manitoba

Investigators ^ICMJE

Principal Investigator:

Ruben E Alvaro, MD

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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