Apnea of Prematurity
Conditions
Keywords
apnea, premature, infant, prematurity
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.
Interventions
OTHERCO2 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
DRUGTheophylline
Sponsors
Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of Manitoba
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
27 Weeks to 32 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide. | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects | 3 days |
Countries
Canada
Outcome results
None listed