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Comparison of Two Methods of Continuous Positive Airway Pressure (CPAP) to Support Successful Extubation of Infants of Birth Weights ≤ 1500 Grams (C2CPAP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Ontario Lung Association
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187434
First received: September 14, 2005
Last updated: January 22, 2007
Last verified: September 2005
  Purpose
Continuous positive airway pressure (CPAP) has been used successfully to promote extubation in the premature infant population. The two methods of CPAP to be examined are currently used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns < 1500 grams (birth weight) at supporting extubation. This randomised controlled study will examine two types of CPAP: the Infant Flow System and the Bubble CPAP. This randomised controlled, single site, clinical study is to determine whether the Bubble CPAP or the Infant Flow System (IFS) CPAP is more effective at supporting the extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised, immediately prior to extubation, to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is successful extubation, defined as not reaching failure criteria for the 7 days post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained increase in FiO2 of 0.15.

Condition Intervention
Premature Birth
Respiratory Insufficiency
Device: Infant Flow System
Device: Bubble CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Control Trial Comparing Two Methods of Delivering Continuous Positive Airway Pressure (CPAP), Infant Flow System CPAP and Bubble CPAP, in Supporting Successful Extubation of Infants of Birth Weights Less Than or Equal to 1500 Grams at Birth (C2CPAP)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • failure of extubation as defined by the following: pH < 7.25 and PCO2 > 65 (or an increase of 15 mmHg from pre-extubation), a sustained (> 1 hour) increase in FiO2 of .15 (as compared to pre-extubation) or significant apno

Secondary Outcome Measures:
  • reintubation
  • length of time in days on CPAP
  • corrected gestational age at cessation of CPAP
  • average weight gain on CPAP
  • assessment of pain will

Estimated Enrollment: 76
Study Start Date: September 2003
Detailed Description:

Background: Continuous Positive Airway Pressure (CPAP) has been used successfully to promote extubation in the premature infant population (Davis & Henderson-Smart, 2002). The two methods of CPAP to be examined are used by many institutions, yet no study has compared these methods to determine which is better in the population of newborns < 1500 grams (birth weight) at supporting extubation. This study may have cost savings implications. If bubble CPAP is shown to be as effective in this application neonatal intensive care units (NICUs) will have a more affordable option of providing effective CPAP.

Methods: This randomised controlled, single site, clinical study is to determine if Bubble CPAP or Infant Flow System (IFS) CPAP is more effective at supporting extubation in infants of birth weights < 1500 grams. Seventy-six infants will be randomised immediately prior to extubation to IFS or Bubble CPAP of 5 cmH2O. The primary outcome is successful extubation, defined as not reaching failure criteria for the 7 days post-extubation. Failure criteria are defined as pH < 7.25 and PCO2 > 65 mmHg or a sustained increase in FiO2 of 0.15.

Participants: Parents/guardians of eligible infants will be approached and given information regarding the study, and any questions answered. They will then be allowed to consider study participation in private. The recruiter will return at an agreed time and informed consent will be obtained from those agreeing to participate. Parents will be approached in accordance with the guidelines of the NICU @ SWCHSC. Infants are eligible if birth weight < 1500 grams, are to be extubated to CPAP and have no known airway anomalies, or suspected genetic anomalies.

Analysis: Multiple ANOVA analysis will be used for continuous variables, chi-square for categorical variables, including primary outcome.

Conclusion: The results of this study will determine which method of CPAP is the best method of supporting extubation in the < 1500 g infant.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intubated infant
  • ≤ 1500 grams at birth
  • Decision to extubate to CPAP made by the clinical team
  • Written informed consent obtained

Exclusion Criteria:

  • Have known airway anomalies
  • Have grade III or IV or periventricular leukomalacia
  • Have known or suspected genetic syndromes
  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: NCT00187434

Locations
Canada, Ontario
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4L 2Y6
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Ontario Lung Association
Investigators
Principal Investigator: Marilyn D Hyndman Sunnybrook & Women's College Health Sciences Centre
  More Information

ClinicalTrials.gov Identifier: NCT00187434     History of Changes
Other Study ID Numbers: 240-2003 
Study First Received: September 14, 2005
Last Updated: January 22, 2007
Health Authority: Australia: Human Research Ethics Committee
Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
premature infant
supporting extubation

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 08, 2016