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Completed

NCT Number: NCT01066728

CO2 Inhalation as a New Treatment Modality for Apnea of Prematurity

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.

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Key information

Conditions

Apnea of Prematurity Apnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

27 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Health Sciences Centre, Winnipeg, Manitoba, Canada

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 inhalation

Other

Inhalation of CO2 (3% at the source, approximately 1% inhaled) with room air by nasal prongs at 0.5 l/min for 3 days

Theophylline

Drug

Primary outcomes

  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 outcomes

  1. Decrease in the rate of long apneas (≥ 20 seconds) and the incidence of short term side effects

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Children's Hospital Foundation of Manitoba

Registry information

Important dates

Study start
2001
Primary completion
2005
Study completion
2007
First posted
Feb 10, 2010
Registry last updated
Mar 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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