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