NCT01066728

CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 27 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
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
DRUG	Theophylline

Timeline

• Start date: 2001-08-01
• Primary completion: 2005-09-01
• Completion: 2007-03-01
• First posted: 2010-02-10
• Last updated: 2010-03-03

Locations

2 sites across 1 country: Canada