CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
|ClinicalTrials.gov Identifier: NCT01066728|
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : March 3, 2010
|Condition or disease||Intervention/treatment||Phase|
|Apnea of Prematurity||Other: CO2 inhalation Drug: Theophylline||Phase 2 Phase 3|
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||August 2001|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||March 2007|
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.
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
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
- The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide. [ Time Frame: 3 days ]
- Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects [ Time Frame: 3 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066728
|St Boniface General Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3E 0L8|
|Principal Investigator:||Ruben E Alvaro, MD||University of Manitoba|