Overview
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
Status:
Completed
Completed
Trial end date:
2007-03-01
2007-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of ManitobaCollaborators:
Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of ManitobaTreatments:
Theophylline
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- Already on methylxanthine treatment
- On supplemental oxygen, nasal continuous positive airway pressure (CPAP)
- Had major congenital anomalies, sepsis, or other known causes of apnea