Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000400662
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
14/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
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)
Scientific title
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)
Universal Trial Number (UTN)
Trial acronym
C2CPAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
It has been shown that premature infants are successfully extubated using CPAP. This study compares two popular methods of delivering CPAP to determine if one is more successful at supporting extubation in infants less than or equal to 1500 gram infants. 506 0
Condition category
Condition code
Reproductive Health and Childbirth 584 584 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 402 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 678 0
The failure of extubation as defined by the following: pH less than 7.25 and PCO2 greater than 65 (or an increase of 15 mmHg from pre extubation), a sustained (greater than 1 hour) increase in FiO2 of .15 (as compared to pre extubation) or significant apnoea and bradycardia requiring manual resuscitation at anytime. If these criteria are met within 7 days post extubation this will be considered failure of extubation.
Timepoint [1] 678 0
Secondary outcome [1] 1385 0
Reintubation
Timepoint [1] 1385 0
Secondary outcome [2] 1386 0
Length of time in days on CPAP
Timepoint [2] 1386 0
Secondary outcome [3] 1387 0
Corrected gestational age at cessation of CPAP
Timepoint [3] 1387 0
Secondary outcome [4] 1388 0
Average weight gain on CPAP
Timepoint [4] 1388 0
Secondary outcome [5] 1389 0
Pain
Timepoint [5] 1389 0
The PIPP score is a valid measurement of pain (Stevens, 1996). PIPP scores will be recorded within 24 hours post CPAP initiation.
Secondary outcome [6] 1390 0
The presence of nasal tissue damage will also be documented but only as an exploratory question.
Timepoint [6] 1390 0

Eligibility
Key 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.
Minimum age
0 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates who:1) Have known airway anomalies2) Have grade III or IV or periventricular leukomalacia3) Have known or suspected genetic syndromes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was completed by a coin toss, with a restriction of blocking. The randomization was also stratified to less than 1000 grams and 1001 to 1500 grams.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment outside Australia
Country [1] 185 0
Canada
State/province [1] 185 0

Funding & Sponsors
Funding source category [1] 638 0
Charities/Societies/Foundations
Name [1] 638 0
Canadian Lung Association
Country [1] 638 0
Canada
Primary sponsor type
Hospital
Name
Sunnybrook and Women's College Health Sciences Centre
Address
Country
Canada
Secondary sponsor category [1] 530 0
University
Name [1] 530 0
Charles Sturt University
Address [1] 530 0
Country [1] 530 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1769 0
Charles Sturt: ETHICS IN HUMAN RESEARCH COMMITTEE
Ethics committee address [1] 1769 0
Ethics committee country [1] 1769 0
Australia
Date submitted for ethics approval [1] 1769 0
Approval date [1] 1769 0
Ethics approval number [1] 1769 0
Ethics committee name [2] 1770 0
Sunnybrook and Women's College Health Sciences Centre Research Ethics Board
Ethics committee address [2] 1770 0
Ethics committee country [2] 1770 0
Australia
Date submitted for ethics approval [2] 1770 0
Approval date [2] 1770 0
Ethics approval number [2] 1770 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35319 0
Address 35319 0
Country 35319 0
Phone 35319 0
Fax 35319 0
Email 35319 0
Contact person for public queries
Name 9591 0
Mariyn Hyndman
Address 9591 0
Sunnybrook and Women's College Health Sciences Centre
76 Grenville St
Toronto ON M5S 1B2
Country 9591 0
Canada
Phone 9591 0
+1 416 3236400 (Ext. 4172)
Fax 9591 0
+1 416 3237314
Email 9591 0
[email protected]
Contact person for scientific queries
Name 519 0
Mariyn Hyndman
Address 519 0
Sunnybrook and Women's College Health Sciences Centre
76 Grenville St
Toronto ON M5S 1B2
Country 519 0
Canada
Phone 519 0
+1 416 3236400 (Ext. 4172)
Fax 519 0
+1 416 3237314
Email 519 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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