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

Premature Birth Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00187434
• Other study ID #: 240-2003
• Status: Recruiting
• Phase: N/A
• First received: September 14, 2005
• Last updated: January 22, 2007
• Start date: September 2003

Study information

• Verified date: September 2005
• Source: Sunnybrook Health Sciences Centre
• Contact: Marilyn D Hyndman
• Phone: 416 323 6400
• Email: marilyn.hyndman[@]sw.ca
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Premature Birth
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Infant Flow System

• Bubble CPAP

Locations

Country	Name	City	State
Canada	Sunnybrook & Women's College Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	reintubation
Secondary	length of time in days on CPAP
Secondary	corrected gestational age at cessation of CPAP
Secondary	average weight gain on CPAP
Secondary	assessment of pain will