Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000137291
Ethics application status
Approved
Date submitted
12/11/2008
Date registered
2/03/2009
Date last updated
30/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
CPAP- Is Pressure Important? A randomised, double blinded, crossover, pilot trial on Continuous Positive Airway Pressure (CPAP), and it's effects upon apnoea, bradycardia and desaturation episodes, and oxygen requirement in preterm infants with respiratory distress syndrome.
Scientific title
Does Continuous Positive Airway Pressure (CPAP) Affect Apnoea, Bradycardia and Desaturation Episodes, and Oxygen Requirement in Preterm Infants on CPAP for Respiratory Distress Syndrome? A Randomised, Double-Blinded Crossover Pilot Trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Distress Syndrome 3841 0
Condition category
Condition code
Reproductive Health and Childbirth 4031 4031 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous Positive Airway Pressure (CPAP) at 8cmH2O supplied via Hudson CPAP to an infant who is already using Hudson CPAP for respiratory support. During two seperate five-hour periods on consecutive days, the infant receiving the CPAP pressure of 8cmH2O will have the oxygen requirement, blood oxygen saturation and heart rate recorded by the Neonatal Unit's electronic bedside monitoring system. The hypothesis is that there is no difference in the number of apnoeas, bradycardias, desaturation episodes and oxygen requirement between the two CPAP pressures of 8cmH2O and 6cmH2O. As this is a pilot study, there will be no defined washout period as we do not yet have enough data to predict how long it would need to be. The length of the washout period would be one of the things we want to discover from the trial.
Intervention code [1] 4099 0
Treatment: Other
Comparator / control treatment
Continuous Positive Airway Pressure (CPAP) at 6cmH2O supplied via Hudson CPAP to infants who are already using Hudson CPAP for respiratory distress. Infants will receive CPAP at 6cmH2O for 2 five hour periods on consecutive days, either before or after they receive 8cmH2O. Once again their observations will be recorded by the electronic bedmaster monitoring system. There will be no formal follow up after the intervention periods have finished as both these CPAP pressures are routinely used in our neonatal unit and can both be regarded as standared treatment for respiratory distress syndrome in the preterm infant. Neonatal intensive care will, of courese, be ongoing.
Control group
Active

Outcomes
Primary outcome [1] 4931 0
Number of clinically significant episodes of apnoea, bradycardia and desaturation episodes requiring intervention by the bedside nurse (stimulation, change in inspired oxygen concentration, bag and mask ventilation) . This will be collected and recorded on the infant's usual nursing chart by the bedside nurse.
Timepoint [1] 4931 0
Information will be collected continuously throughout the trial period by the bedside nurse, as it would be collected as usual in the intensive-care environment. As a minimum, all stable observations will be recorded hourly and all interventions will be recordd as they occur.
Primary outcome [2] 4932 0
Episodes of apnoea, bradycardia and desaturation as recorded on the bedside cardiorespiratory and saturation monitor (Apnoea defined as cessation of breathing for longer than 20 seconds, or shorter if associated with bradycardia or desaturation.) This will be assessed by examination of the data collected by the bedside electronic monitoring and comparison of the number, duration and severity of events.
Timepoint [2] 4932 0
Information will be collected by the bedside monitor continuously throughout the trial period.
Primary outcome [3] 4933 0
Mean inspired oxygen concentration to maintain saturations as per current unit guidelines (oxygen saturation levels maintained between 86% and 94% in premature infants on supplemental oxygen.) Assessment by comparion of data readouts from the electronic monitoring system.
Timepoint [3] 4933 0
Every 6 seconds throughout the trial period.
Secondary outcome [1] 8314 0
Possible need for and duration of a washout period will be assessed by examination of all the data collected to look for an increase in instability after a change in CPAP pressure and at what point this instability resolves.
Timepoint [1] 8314 0
End of trial
Secondary outcome [2] 8315 0
Feasability of using 6cmH2O and 8cmH2O as CPAP pressure settings in a larger trial of CPAP pressures. This will be assessed by the finding of any statistical trend towards a difference in between the two pressures from the electronic and bedside data which is collected.
Timepoint [2] 8315 0
This will be assessed when all the data from all 10 infants enetered into the trial has been collected and compared.

Eligibility
Key inclusion criteria
Premature infant of less than 30 weeks corrected gestational age, diagnosis of respiratory distress syndrome, ongoing respiratory distress or apnoea of prematurity requiring treatment with CPAP, stable on CPAP for the past 48 hours, no changes to caffeine dose (if used) for 48 hours.
Minimum age
24 Weeks
Maximum age
30 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major congenital of chromosomal abnormality, treatment with doxapram for troublesome apnoea, current post-natal corticosteroid treatment, any contraindication to the use of CPAP

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, opaque envelope method
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation method: There will be 5 opaque envelopes containing an allocation to each pathway (10 participants). These identical envelopes will be shuffled and one chosen at random for each participant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
26/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1283 0
New Zealand
State/province [1] 1283 0

Funding & Sponsors
Funding source category [1] 4153 0
Self funded/Unfunded
Name [1] 4153 0
Country [1] 4153 0
Primary sponsor type
Individual
Name
Anna Tottman
Address
Paediatric Registrar
Newborn Services
National Women's Hospital
Auckland City Hospital
2, Park Road
Grafton
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 3734 0
None
Name [1] 3734 0
Address [1] 3734 0
Country [1] 3734 0
Other collaborator category [1] 475 0
Individual
Name [1] 475 0
Mariam Buksh
Address [1] 475 0
Neonatologist
Newborn Services
National Women's Hospital
Auckland City Hospital
2, Park Road
Grafton
Auckland 1010
Country [1] 475 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6596 0
Northern X Regional Ethics Committee
Ethics committee address [1] 6596 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Rd, Penrose
Private Bag 92 522
Wellesley Street
Auckland
Ethics committee country [1] 6596 0
New Zealand
Date submitted for ethics approval [1] 6596 0
14/10/2008
Approval date [1] 6596 0
20/01/2009
Ethics approval number [1] 6596 0
NTX/08/10/097

Summary
Brief summary
This pilot study intends to compare the effect of two different levels of positive end-expiratory pressure (PEEP) on the respiratory status of premature infants who require continuous positive airway support (CPAP) for the treatment of respiratory distress syndrome. Our hypothesis that there is no difference in the number of apnoea, bradycardia and desaturation episodes, and oxygen requirement when using PEEP 6cmH2O as compared to 8cmH2O.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29047 0
Address 29047 0
Country 29047 0
Phone 29047 0
Fax 29047 0
Email 29047 0
Contact person for public queries
Name 12204 0
Dr Anna Tottman
Address 12204 0
Newborn Services
National Women's Hospital
Auckland City Hospital
2, Park Road
Grafton
Auckland 1010
Country 12204 0
New Zealand
Phone 12204 0
+64 9 3074949
Fax 12204 0
Email 12204 0
[email protected]
Contact person for scientific queries
Name 3132 0
Dr Anna Tottman
Address 3132 0
Newborn Services
National Women's Hospital
Auckland City Hospital
2, Park Road
Grafton
Auckland 1010
Country 3132 0
New Zealand
Phone 3132 0
+64 9 3074949
Fax 3132 0
Email 3132 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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