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CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

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ClinicalTrials.gov Identifier: NCT01066728
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : March 3, 2010
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Children's Hospital Foundation of Manitoba
Information provided by:
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Other: CO2 inhalation Drug: Theophylline Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2001
Actual Primary Completion Date : September 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The decrease in total apnea time (duration of all apneic pauses ≥ 5 seconds) during administration of theophylline and carbon dioxide. [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects [ Time Frame: 3 days ]


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Ages Eligible for Study:   27 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Ruben E. Alvaro, MD, University of Manitoba
ClinicalTrials.gov Identifier: NCT01066728     History of Changes
Other Study ID Numbers: E98:242
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: January 2010

Keywords provided by University of Manitoba:
apnea
premature
infant
prematurity

Additional relevant MeSH terms:
Apnea
Premature Birth
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents