CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
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.
Apnea of Prematurity
Other: CO2 inhalation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- 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 ]
- 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 ]
|Study Start Date:||August 2001|
|Study Completion Date:||March 2007|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|