CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01066728
First received: February 9, 2010
Last updated: March 1, 2010
Last verified: January 2010

February 9, 2010
March 1, 2010
August 2001
September 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01066728 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
Not Provided

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.

  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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Apnea of Prematurity
  • 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
  • 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.
    Intervention: Drug: Theophylline
  • 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
    Intervention: Other: CO2 inhalation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
March 2007
September 2005   (final data collection date for primary outcome measure)

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
Both
27 Weeks to 32 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01066728
E98:242
Yes
Ruben E. Alvaro, MD, University of Manitoba
University of Manitoba
  • Canadian Institutes of Health Research (CIHR)
  • The Children's Hospital Foundation of Manitoba
Principal Investigator: Ruben E Alvaro, MD University of Manitoba
University of Manitoba
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP