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Comparison of two methods of continuous positive airway pressure (CPAP) to support successful extubation of infants of birth weights less than or equal to 1500 grams (C2CPAP)

A randomised 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)

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000400662
Acronym
C2CPAP
Enrollment
76
Registered
2005-09-14
Start date
2003-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Continuous Positive Airway Pressure (CPAP) has been used successfully to promote extubation in the premature infant population (Davis & Henderson-Smart, 2002). 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 less than or equal to 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 less than 7.25 and PCO2 greater than 65 mmHg, a sustained increase in FiO2 of 0.15. Analysis: Multiple ANOVA analysis will be used for continuous variables, chi-square for categorical variables, including primary outcome. Conclusion: The conclusion of this study will show if IFS or Bubble CPAP is the better method of supporting extubation in the less than or equal to 1500g infant.

Interventions

When the clinical team has made the decision that an infant will be extubated to CPAP parents will be approached regarding this study. If parents are willing to receive information, it will be given at this time, and all questions answered. The recruiter will then withdraw to allow parents to consider participation privately, returning at a mutually agreeable time to receive parents decision. If parents agree to this study this will be documented on the infants chart and members of the clinical

When the clinical team has made the decision that an infant will be extubated to CPAP parents will be approached regarding this study. If parents are willing to receive information, it will be given at this time, and all questions answered. The recruiter will then withdraw to allow parents to consider participation privately, returning at a mutually agreeable time to receive parents decision. If parents agree to this study this will be documented on the infants chart and members of the clinical team will be notified. Immediately before extubation the infant will be randomized to Bubble CPAP (experimental group) or to receive Infant Flow System (IFS) CPAP (standard group). The respiratory therapist (RRT) on duty will pick the next randomization card in the appropriate size group (less than1000 g and 1001 to 1500 g). If randomized to the bubble CPAP (experimental arm of this study), an infant upon extubation, will be placed on a bubble CPAP system. A CPAP level of 5 cm H2O will be initiated. The bubble CPAP system will consist of a humidified, blended (oxygen and air) gas source delivered through a heated wire disposable circuit. The CPAP will be delivered by placing the expiratory limb of the patient circuit in a container of water to the desired depth. The expiratory portion of the circuit will be placed five centimetres under water, which will deliver 5 cmH2O of CPAP. There will be eight centimeters of water in the container to ensure that an excessive CPAP level cannot be accidentally attained. A flow of 6 to 8 lpm will be used to meet the inspiratory flow demand of the infant and to ensure a consistent bubbling of H2O in the system. The interface between the infant and the bubble CPAP will be Hudson dual nasal prongs. These prongs come in different sizes and the appropriate size of prong will be used as recommended by the manufacturer and as judged by the bedside clinician to ensure a comfortable and effective seal. If randomized to the IFS CPAP (standard treatment arm of this study), an infant upon extubation will be placed on an IFS CPAP system. A CPAP level of 5 cm H2O will be initiated, a flow adequate to achieve this level of CPAP will be used ~ 8 lpm as suggested by the manufacturer. Nasal prongs of an appropriate size as recommended by the manufacturer and judged by the bedside clinician will be used to provide the interface between the infant and the IFS. A Premature Infant Pain Profile (PIPP) Score will be evaluated within the 24 hours post initiation of CPAP device. An infant will remain on CPAP unless failure criteria are met or specific criteria are met to wean infant off CPAP. If the infant does not meet reintubation criteria within 7 days of extubation, extubation will be considered successful. If an infant is reintubated the reason for reintubation will be documented. An infant may be removed from CPAP if the following criteria are met FiO2 < 0.30, respiratory rate <80 and < than one per hour apnoea or bradycardia episodes requiring stimulation in the previous 12 hours. If the infant needs to go back onto CPAP this will not be considered a negative outcome.

Sponsors

Sunnybrook and Women's College Health Sciences Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 3 Years
Healthy volunteers
No

Inclusion criteria

1) Intubated infant 2) less than or equal to 1500 grams at birth 3) Decision to extubate to CPAP made by the clinical team 4) Written informed consent obtained.

Exclusion criteria

Neonates who:1) Have known airway anomalies2) Have grade III or IV or periventricular leukomalacia3) Have known or suspected genetic syndromes.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026