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Trial registered on ANZCTR


Trial ID
ACTRN12612000386831
Ethics application status
Not yet submitted
Date submitted
2/04/2012
Date registered
4/04/2012
Date last updated
4/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of intranasal remifentanil for intubation and surfactant administration in newborns
Scientific title
Intranasal remifentanil for pain management during intubation and surfactant administration in premature newborns – a randomised double blind controlled pilot study of efficacy
Secondary ID [1] 280251 0
Nil
Universal Trial Number (UTN)
Trial acronym
RHINO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management for premature infants undergoing intubation. 286203 0
Condition category
Condition code
Reproductive Health and Childbirth 286414 286414 0 0
Complications of newborn
Anaesthesiology 286438 286438 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prior to the intubation surfactant extubation (INSURE) procedure, babies will receive standard care plus intranasal remifentanil 2 micrograms/kg.
Intervention code [1] 284595 0
Treatment: Drugs
Comparator / control treatment
The comparator treatment is standard care plus intranasal normal saline. Standard care is defined as employing comfort and environmental methods as deemed appropriate by staff. Oral sucrose may be used according to NICU standard protocol.
Control group
Placebo

Outcomes
Primary outcome [1] 286862 0
The proportion of infants with good or excellent intubating conditions.

Base-line cardiorespiratory and sleep-wake data will be recorded in order to calculate the immediate post-procedural Premature Infant Pain Profile (PIPP) score. Real-time physiological data will be downloaded from monitors for later analysis. These include: blood pressure obtained using an arterial transducer or a non-invasive blood pressure module; heart rate obtained from an electrocardiogram lead attached to cardiogram/respiratory monitor; and oxygen saturation obtained from an oxygen saturation monitor.
Timepoint [1] 286862 0
1 and 3 minutes after intubation. Real-time physiological data will be downloaded from monitors for later analysis.
Secondary outcome [1] 296829 0
Pain assessed using the Premature Infant Pain Profile (PIPP) score
Timepoint [1] 296829 0
1 and 3 minutes after intubation
Secondary outcome [2] 296830 0
Number of intubation attempts and total duration (limit of 3 attempts OR 20 seconds each attempt OR intubation associated with desaturations and bradycardia).
Timepoint [2] 296830 0
The duration of the procedure
Secondary outcome [3] 296831 0
Adverse events including episodes of bradycardia and number of neonates requiring intervention (volume expanders or inotropes) for hypotension
Timepoint [3] 296831 0
The first hour after study drug administration
Secondary outcome [4] 296832 0
Ventilatory changes
Timepoint [4] 296832 0
The first hour after study drug administration
Secondary outcome [5] 296833 0
Neonatal outcome at discharge from NICU (satisfactory weight gain, equivalent to term corrected, breathing on own without respiratory support, can suck and feed without the need of assistance eg. gastric tube feeding, can maintain body temperature).
Timepoint [5] 296833 0
At discharge from NICU.

Eligibility
Key inclusion criteria
Born at John Hunter Childrens Hospital and transferred to Neonatal Intensive Care Unit.
Require the INSURE procedure as part of their medical care.
Are 28–44 weeks post-conceptional age at the time of the procedure.
Minimum age
28 Weeks
Maximum age
44 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Need for urgent intubation for resuscitation.
Major congenital anomalies likely to influence reliability of the primary outcome measure.
Severe neurological obtundation.
Current clinical seizures.
Concomitant muscle relaxant.

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)
The person determining if a subject is eligible for inclusion in the trial is unaware to which group the subject will be allocated. Allocation is concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved by a prepared randomisation schedule using a computerised random-number generator, stratified by corrected gestational age (<32 weeks, >32 weeks).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
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)
Recruitment postcode(s) [1] 5169 0
2310

Funding & Sponsors
Funding source category [1] 285019 0
Hospital
Name [1] 285019 0
John Hunter Hospital, Charitable Trust
Address [1] 285019 0
Lookout Road
New Lambton NSW 2310
Country [1] 285019 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Ian Wright
Address
Kaleidoscope Neonatal Intensive Care Unit
John Hunter Children's Hospital
Lookout Road
New Lambton NSW 2310
Country
Australia
Secondary sponsor category [1] 283884 0
Individual
Name [1] 283884 0
Dr Susan Lord
Address [1] 283884 0
Anaesthesia, Intensive Care & Pain Management
John Hunter Children's Hospital
Lookout Road
New Lambton NSW 2310
Country [1] 283884 0
Australia
Other collaborator category [1] 260681 0
Individual
Name [1] 260681 0
Kate O'Hara
Address [1] 260681 0
Hunter Medical Research Institute
John Hunter Hospital
Lookout Road
New Lambton NSW 2310
Country [1] 260681 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287022 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 287022 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 287022 0
Australia
Date submitted for ethics approval [1] 287022 0
01/05/2012
Approval date [1] 287022 0
Ethics approval number [1] 287022 0

Summary
Brief summary
The primary purpose of this study is to determine the efficacy of intranasal remifentanil for improving intubating conditions in neonates requiring the INSURE procedure as part of their medical care. Usual pain management (comfort/environmental measures and age/weight-appropriate sucrose) will be provided to all neonates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34005 0
Address 34005 0
Country 34005 0
Phone 34005 0
Fax 34005 0
Email 34005 0
Contact person for public queries
Name 17252 0
Associate Professor Ian Wright
Address 17252 0
Kaleidoscope Neonatal Intensive Care Unit
John Hunter Children's Hospital
Lookout Rd
New Lambton NSW 2310
Country 17252 0
Australia
Phone 17252 0
+61 2 49214362
Fax 17252 0
Email 17252 0
Ian.Wright@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 8180 0
Associate Professor Ian Wright
Address 8180 0
Kaleidoscope Neonatal Intensive Care Unit
John Hunter Children's Hospital
Lookout Rd
New Lambton NSW 2310
Country 8180 0
Australia
Phone 8180 0
+61 2 49214362
Fax 8180 0
Email 8180 0
Ian.Wright@hnehealth.nsw.gov.au