CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity
This study has been completed.
Sponsor:
University of Manitoba
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
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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:
- 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.
- To discover whether inhalation of low CO2 decreases apneas, particularly prolonged apneas (>20 seconds), more effectively than theophylline.
- 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
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 Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Vasodilator Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013