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

NCT ID: NCT00187434

Last Updated: 2007-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30

Brief Summary

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.

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.

Conditions

Premature Birth; Respiratory Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Infant Flow System

Intervention Type: DEVICE

Bubble CPAP

Intervention Type: DEVICE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Lung Association

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Principal Investigators

Marilyn D Hyndman

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook & Women's College Health Sciences Centre

Locations

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Marilyn D Hyndman

Role: CONTACT

marilyn.hyndman@sw.ca

416 323 6400 ext. 4172

Facility Contacts

Marilyn D Hyndman

Role: primary

marilyn.hyndman@sw.ca

416 323 6400 ext. 4172

References

Ho JJ, Zakarija-Grkovic I, Lok JW, Lim E, Subramaniam P, Leong JJ. Continuous positive airway pressure (CPAP) for apnoea of prematurity. Cochrane Database Syst Rev. 2023 Jul 18;7(7):CD013660. doi: 10.1002/14651858.CD013660.pub2.

Reference Type: DERIVED

PMID: 37481707 (View on PubMed)

Other Identifiers

240-2003

Identifier Type: -

Identifier Source: org_study_id