CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|