CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 87 enrolled
Drug / intervention
Theophylline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01066728
NCT01066728Phase 3Completed
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CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

University of Manitoba·interventional·Posted Feb 10, 2010·Updated Mar 3, 2010

In Brief

A Phase 3 clinical trial evaluating CO2 inhalation and Theophylline for Apnea of Prematurity. Completed, enrolled 87 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsApnea of Prematurity
CountriesCanada
CollaboratorsCanadian Institutes of Health Research (CIHR), The Children's Hospital Foundation of Manitoba

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2010
Enrollment StartAug 1, 2001
Primary CompletionSep 1, 2005
Study CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.4 years ago

Interventions

CO2 inhalationother

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

Theophyllinedrug