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
  Purpose

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.


Condition Intervention Phase
Apnea of Prematurity
Other: CO2 inhalation
Drug: Theophylline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 87
Study Start Date: August 2001
Study Completion Date: March 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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

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.
  Eligibility

Ages Eligible for Study:   27 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066728

Locations
Canada, Manitoba
St Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3E 0L8
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of Manitoba
Investigators
Principal Investigator: Ruben E Alvaro, MD University of Manitoba
  More Information

Publications:
Responsible Party: Ruben E. Alvaro, MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01066728     History of Changes
Other Study ID Numbers: E98:242
Study First Received: February 9, 2010
Last Updated: March 1, 2010
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
apnea
premature
infant
prematurity

Additional relevant MeSH terms:
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 19, 2014