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Trial registered on ANZCTR


Registration number
ACTRN12608000277347
Ethics application status
Approved
Date submitted
27/05/2008
Date registered
30/05/2008
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Propofol compared to Morphine and Midazolam for facilitating neonatal intubation: A randomized, controlled trial
Scientific title
Propofol compared to Morphine and Midazolam for facilitating neonatal intubation: A randomized, controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trial of propofol versus morphine and midazolam for facilitating elective and semi-elective neonatal intubations in a neonatal unit. 3194 0
Neonates of more than 28 weeks' gestational age, needing elective or semi-elective intubation in the neonatal unit. 3195 0
Condition category
Condition code
Anaesthesiology 3357 3357 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Propofol in a dose of 3mg/kg as an intravenous bolus dose. A maximum of 2 doses will be allowed.
Intervention code [1] 2958 0
Treatment: Drugs
Comparator / control treatment
Morphine and Midazolam as an intravenous bolus. The dose is 100 microgram/kg as a bolus. A maximum of 2 doses will be allowed.
Control group
Active

Outcomes
Primary outcome [1] 4272 0
Time to successful intubation.
Timepoint [1] 4272 0
Time from randomization until time ETT is confirmed in position.
Primary outcome [2] 4273 0
Ease of intubation.
Timepoint [2] 4273 0
At the completion of intubation, with a questionaire. (Helbo-Hansen scoring method.)
Primary outcome [3] 4274 0
Hemodynamic parameters
Timepoint [3] 4274 0
From injection of study drug to completion of intubation effort.
Secondary outcome [1] 7172 0
Long term neurological follow up.
Timepoint [1] 7172 0
2 years

Eligibility
Key inclusion criteria
All infants > 28 weeks' gestation, with parental consent, in the neonatal unit, who need elective or semi-elective endotracheal intubation.
Minimum age
28 Weeks
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No parental consent.
Infants with major congenital abnormalities.
Infants with cyanotic congenital heart lesions, incl. infants with duct-dependant circulation.
Infants with hypotension.
Infants with hypovolemia.
Infants with hypoxic ischaemic encephalopathy.
Infants who are deemed septic.
Infants with suspected or proven metabolic diseases.
Infants with a family history of metabolic disease.
Infants with pulmonary hypertension

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)
Informed consent will be obtained prior to intubation. Infants that may potentially require intubation during their admission will be recruited (and informed consent obtained) soon after admission.
Treatment group allocation will be recorded in ordered, opaque envelopes with the sequence of allocation determined by randomisation.
For the first intubation attempt (eligible for inclusion) the next envelope will be opened once the decision is made to intubate (using sedation) by the medical staff.
Once treatment group allocation has occurred, all subsequent intubations with sedation for that infant will be done using the assigned sedative.
Blinding will not be possible, as the preparations look different, propofol is a milky-white substance that needs no diluting and morphine midazolam is clear.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3428 0
Hospital
Name [1] 3428 0
Royal Brisbane and Women's Hospital
Address [1] 3428 0
Herston
Country [1] 3428 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Herston
Country
Australia
Secondary sponsor category [1] 3070 0
None
Name [1] 3070 0
Address [1] 3070 0
Country [1] 3070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5453 0
Royal Brisbane and Women's Hospital Health Service District Reasearch Ethics Committee
Ethics committee address [1] 5453 0
Level 7, Block 7
Royal Brisbane and Womens' Hospital
Butterfield Street
Herston
Brisbane
Queensland
4029
Ethics committee country [1] 5453 0
Australia
Date submitted for ethics approval [1] 5453 0
24/01/2008
Approval date [1] 5453 0
06/05/2008
Ethics approval number [1] 5453 0
2008/018
Ethics committee name [2] 5454 0
Royal Brisbane and Women's Hospital Helth Service District Research Ethics Cimmittee.
Ethics committee address [2] 5454 0
Level 7, Block 7
Royal Brisbane and Womens' Hospital
Butterfield Street
Ethics committee country [2] 5454 0
Australia
Date submitted for ethics approval [2] 5454 0
Approval date [2] 5454 0
06/05/2008
Ethics approval number [2] 5454 0
2008/018

Summary
Brief summary
Ill newborns frequently need breathing tubes inserted into their trachea in order to help with their breathing. This can cause pain and adverse physiological responses, such as changes in blood pressure, which may be harmful to the infant. We routinely give these infants medications beforehand, to lessen the impact the procedure has on them. The best drug or drug combination in infants is not known. In our neonatal unit, we use a combination of Morphine and Midazolam, which may not be ideal, as it takes long to work. We aim to compare these 2 drugs with a single agent, Propofol, an anaesthetic agent, used in theatres to insert breathing tubes. We do not know which of these drugs are better, that is why we have started this study. The study is expected to run for 18 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28621 0
Address 28621 0
Country 28621 0
Phone 28621 0
Fax 28621 0
Email 28621 0
Contact person for public queries
Name 11778 0
Pieter Koorts
Address 11778 0
Grantley Stable Neonatal Unit
Royal Brisbane and Womens' Hospital
Butterfield Street
Herston
Brisbane
Queensland
4029
Country 11778 0
Australia
Phone 11778 0
+61736360563
Fax 11778 0
+61736365259
Email 11778 0
Pieter_Koorts@health.qld.gov.au
Contact person for scientific queries
Name 2706 0
Pieter Koorts
Address 2706 0
Grantley Stable Neonatal Unit
Royal Brisbane and Womens' Hospital
Butterfield Street
Herston
Brisbane
Queensland
4029
Country 2706 0
Australia
Phone 2706 0
+61736360563
Fax 2706 0
+61736365259
Email 2706 0
Pieter_Koorts@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary