Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001057976
Ethics application status
Approved
Date submitted
3/10/2011
Date registered
10/10/2011
Date last updated
2/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of nasal continuous positive airway pressure on cardiac function in (i) premature infants with established lung disease and (ii) premature infants with minimal lung disease.
Scientific title
In preterm infants with a corrected gestational age of 28-34 weeks, do levels of nasal CPAP of 4 or 8 cm of water affect right ventricular cardiac output?
Secondary ID [1] 273127 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
effect of nasal CPAP on right ventricular output 270884 0
in premature infants with significant lung disease and minimal lung disease 278904 0
Condition category
Condition code
Cardiovascular 279057 279057 0 0
Normal development and function of the cardiovascular system
Reproductive Health and Childbirth 279085 279085 0 0
Complications of newborn
Respiratory 279116 279116 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
nasal continuous positive airway pressure of 4, 6 and 8 centimeter of water for 15 minutes each in randomized order. There will be 5-10 minutes before changing to the next CPAP level to allow for echocardiographic assessment.
Intervention code [1] 269468 0
Treatment: Devices
Comparator / control treatment
each infants is his/her own control as different levels of nasal CPAP are compared
Control group
Dose comparison

Outcomes
Primary outcome [1] 279708 0
right ventricular output, assessed by echocardiography
Timepoint [1] 279708 0
15 minutes after each change in nCPAP level
Secondary outcome [1] 294268 0
left ventricular output, assessed by echocardiography
Timepoint [1] 294268 0
15 minutes after each change in nCPAP level

Eligibility
Key inclusion criteria
Premature infants with a corrected gestational age of 28-34 weeks, admitted to the Neonatal Intensive and Special Care and treated with nasal CPAP.
Minimum age
28 Weeks
Maximum age
34 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with sepsis, organ failure, necrotizing enterocolitis, seizures, or identified by the clinical team to be too sick to participate in the study will be excluded.
Infants will be excluded if they have congenital heart disease including a haemodynamically significant patent ductus arteriosus (PDA), atrial septal defect (ASD)/persistent foramen ovale (PFO) and/or ventricular septal defect (VSD). Infants will also be excluded if they are treated with fractional inspired oxygen (FiO2) of more than 40%, and/or treated with a PEEP higher than 7 cmH2O, or nasal intermittent mandatory ventilation (nIMV).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2011
Actual
6/12/2011
Date of last participant enrolment
Anticipated
Actual
20/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2289 0
The Royal Women's Hospital - Parkville
Recruitment hospital [2] 2290 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 269949 0
Self funded/Unfunded
Name [1] 269949 0
n/a
Country [1] 269949 0
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
CNR Grattan Street and Flemington Rd
Parkville, Victoria 3052
Country
Australia
Secondary sponsor category [1] 268946 0
None
Name [1] 268946 0
n/a
Address [1] 268946 0
n/a
Country [1] 268946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271918 0
Ethics committee address [1] 271918 0
Ethics committee country [1] 271918 0
Date submitted for ethics approval [1] 271918 0
05/10/2011
Approval date [1] 271918 0
Ethics approval number [1] 271918 0

Summary
Brief summary
The aim of the study is to determine changes in blood flow in the heart associated with low or high air pressures given with the nasal prong breathing support to the prematurely born infant. Research studies have shown that nasal CPAP can influence the way the blood flows in premature infants.
We want to find out if the CPAP machine affects the function of the heart and the blood flow to the lungs. So that we can learn what is the most appropriate level of CPAP for infants with different types of lung disease that provides respiratory support with least affect on heart function.
Trial website
Trial related presentations / publications
The effects of nasal continuous positive airway pressure on cardiac function in premature infants with minimal lung disease: a crossover randomized trial.
Beker F, Rogerson SR, Hooper SB, Wong C, Davis PG.
J Pediatr. 2014 Apr;164(4):726-9
Public notes

Contacts
Principal investigator
Name 33212 0
Dr Sheryle Rogerson
Address 33212 0
The Women's Hospital Cnr Grattan Street/Flemington Rd PArkville, Vic 3052
Country 33212 0
Australia
Phone 33212 0
+61 3 83452000
Fax 33212 0
Email 33212 0
sheryle.rogerson@thewomens.org.au
Contact person for public queries
Name 16459 0
Dr Dr Sheryle Rogerson
Address 16459 0
The Women's Hospital
Cnr Grattan Street/Flemington Rd
PArkville, Vic 3052
Country 16459 0
Australia
Phone 16459 0
+61 3 83452000
Fax 16459 0
+61 3 8345 3789
Email 16459 0
sheryle.rogerson@thewomens.org.au
Contact person for scientific queries
Name 7387 0
Dr Dr Sheryle Rogerson
Address 7387 0
The Women's Hospital
Cnr Grattan Street/Flemington Rd
Parkville, Vic 3052
Country 7387 0
Australia
Phone 7387 0
+61 3 8345 2000
Fax 7387 0
Email 7387 0
sheryle.rogerson@thewomens.org.au

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

Documents added manually
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Documents added automatically
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