CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
- Registration Number
- NCT01066728
- Lead Sponsor
- University of Manitoba
- 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
1. 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.
2. To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (\>20 seconds), more effectively than theophylline.
3. To discover whether short term (during hospitalization) and long term (2 years) adverse side effects are less pronounced with CO2 than with theophylline.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- 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
- Already on methylxanthine treatment
- On supplemental oxygen, nasal continuous positive airway pressure (CPAP)
- Had major congenital anomalies, sepsis, or other known causes of apnea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Theophylline 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. CO2 inhalation 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
- Primary Outcome Measures
Name Time Method The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide. 3 days
- Secondary Outcome Measures
Name Time Method Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects 3 days
Trial Locations
- Locations (2)
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
St Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada