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Trial registered on ANZCTR


Registration number
ACTRN12610000857000
Ethics application status
Approved
Date submitted
20/09/2010
Date registered
14/10/2010
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Aerosolized surfactant in the first hour of life
Scientific title
An open label, randomised, controlled pilot study to evaluate the safety and efficacy of aerosolised surfactant in the first hour of life in preterm infants with respiratory distress syndrome (RDS)
Secondary ID [1] 252725 0
N/A
Universal Trial Number (UTN)
Trial acronym
CureNeb
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant Respiratory Distress Syndrome 258129 0
Condition category
Condition code
Respiratory 258305 258305 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 258426 258426 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 258427 258427 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nebulisation of animal derived lung surfactant commenced within the first hour of life, whilst infant supported on Constant Positive Airway Pressure (CPAP). Surfactant will be redosed by nebulisation 12 h after initial dosing if infant remains on CPAP and continues to have evidence of respiratory distress and/or oxygen requirement.
Curosurf dose will be 200 mg/kg for 29 w 0 d - 33 w 6 d gestation infants, and 100 mg/kg for newborns born at 34 w 0 d - 39 w 6 d gestation.
Intervention code [1] 257143 0
Treatment: Devices
Intervention code [2] 257265 0
Treatment: Drugs
Comparator / control treatment
Standard treatment normally includes CPAP support only for mild-moderate severity of respiratory distress. If infants require surfactant, normal protocol is intubation, mechanical ventilation and bolus instillation of the same dose of surfactant via the tracheal tube. Standard unit treatment protocol will be the control group in this RCT.
Control group
Active

Outcomes
Primary outcome [1] 259152 0
Need for intubation.
Criteria for intubation will include one or more of the following:
a) FiO2 > 0.35 over more than 30 minutes OR
b) FiO2 > 0.45 at anytime, OR
c) more than 4 apnoeas per hour OR
d) two apnoeas requiring bag and mask ventilation, OR
e) two capillary blood gas samples with a pH < 7.2 and pCO2 > 65 mmHg (or 60 mm Hg if arterial blood gas sample)
f) clinical deterioration necessitating intubation as judged by the treating clinician
Timepoint [1] 259152 0
Need for intubation in first 72 h of life
Primary outcome [2] 259153 0
Duration of mechanical ventilation assessed in minutes from prospective documentation.

Extubation criteria:babies will be extubated at the discretion of the attending consultant with regard to oxygen requirement and clinical condition
Timepoint [2] 259153 0
Duration of mechanical ventilation at the end of the 1st 72 h of life.
Secondary outcome [1] 265479 0
Safety of the nebulisation procedure will be assessed by recording of apnea events and need for nasal suction occurring during the nebulisation period and comparing those to the background rate of apnea in the control group.
We will also record any significant clinical event during nebulisation requiring medical intervention.

Safety of the procedure will be further assessed by development of airleak syndromes, and frequency of apnea and/or bradycardia in the first 72 hours
Timepoint [1] 265479 0
Assessments will be made over the period of nebulisation, and again at 72 hours.
Secondary outcome [2] 265480 0
Physiological stability as determined by respiratory rate, pulse rate, mean blood pressure, FiO2, and blood pH
Timepoint [2] 265480 0
72 h
Secondary outcome [3] 265897 0
Number of surfactant treatments administered
Timepoint [3] 265897 0
72 h
Secondary outcome [4] 265898 0
Duration of mechanical ventilation
Timepoint [4] 265898 0
14 d
Secondary outcome [5] 265899 0
Any airleak syndrome
Timepoint [5] 265899 0
72 h

Eligibility
Key inclusion criteria
Preterm infants with a gestational age (GA) between 29 w 0 d and 33 w 6 d AND
late preterm and term infants with a GA between 34 w 0 d and 39 w 6 d
with clinical or radiological signs of RDS requiring FiO2 of 0.22- 0.30 to maintain a peripheral haemoxyglobin saturation of 88-94%.
Minimum age
0 Hours
Maximum age
1 Hours
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiorespiratory instability, cardiothoracic malformations, obvious chromosomal aberrations

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 envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
WA

Funding & Sponsors
Funding source category [1] 257595 0
Government body
Name [1] 257595 0
State Health Research Advisory Council of Western Australia (SHRAC)
Address [1] 257595 0
SHRAC
C/o Research Development Unit
Department of Health

PO Box 8172,
Perth Business Centre, WA 6849
Country [1] 257595 0
Australia
Funding source category [2] 257813 0
Charities/Societies/Foundations
Name [2] 257813 0
Women and Infants Research Foundation
Address [2] 257813 0
c/- Carson House,
King Edward Memorial Hospital,
374 Bagot Rd,
Subiaco, WA, 6008
Country [2] 257813 0
Australia
Funding source category [3] 257814 0
Charities/Societies/Foundations
Name [3] 257814 0
Women and Infants Research Foundation
Address [3] 257814 0
c/- Carson House,
King Edward Memorial Hospital,
374 Bagot Rd,
Subiaco, WA, 6008
Country [3] 257814 0
Australia
Primary sponsor type
University
Name
School of Women’s and Infants’ Health (SWIH)
Address
The University of Western Australia
35 Stirling Hwy
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 256823 0
University
Name [1] 256823 0
School of Paediatrics and Child Health (SPACH)
Address [1] 256823 0
The University of Western Australia
35 Stirling Hwy
CRAWLEY WA 6009
Country [1] 256823 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259617 0
Women and Newborn Health Service (WNHS) Ethics Committee
Ethics committee address [1] 259617 0
Level 1,
Children's Clinical
Research Facility (CCRF)
Princess Margaret Hospital
GPO Box D184
Perth WA 6840
Ethics committee country [1] 259617 0
Australia
Date submitted for ethics approval [1] 259617 0
Approval date [1] 259617 0
06/10/2010
Ethics approval number [1] 259617 0
1753/EW

Summary
Brief summary
Surfactant replacement is the mainstay in prevention and therapy of respiratory distress syndrome (RDS) in preterm neonates. Early treatment with surfactant reduces mortality, and incidence of chronic lung disease (CLD) and air leaks in preterm infants at risk of RDS.
Current therapy consists of instilling a liquid bolus of surfactant into the trachea through an endotracheal tube, followed by mechanical ventilation of variable duration. This treatment actually requires the patient to be admitted to a level III care nursery and a risk of ventilator induced lung injury.

We propose a new approach to surfactant treatment for moderately preterm infants born with respiratory distress, as well as for more mature infants born in a non-tertiary hospital setting. By using nebulised surfactant, we propose that babies will have their mild-moderate respiratory disease treated without the need for invasive ventilation or transport to a tertiary neonatal unit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31605 0
Prof JJ Pillow
Address 31605 0
M309, APHB
Hackett Entrance 2,
Hackett Drive, Crawley, 6009, WA
Country 31605 0
Australia
Phone 31605 0
+61 864883318
Fax 31605 0
Email 31605 0
jane.pillow@uwa.edu.au
Contact person for public queries
Name 14852 0
Dr Dr Stefan Minocchieri
Address 14852 0
School of Paediatrics and Child Health
Level 4, Admin Building
Roberts Rd
Subiaco, WA, 6008
Country 14852 0
Australia
Phone 14852 0
+61 8 9340 8452
Fax 14852 0
Email 14852 0
sminocchieri@meddent.uwa.edu.au
Contact person for scientific queries
Name 5780 0
Prof Prof JJ Pillow
Address 5780 0
King Edward Memorial Hospital
Neonatal Special Care Nursery
Bagot Rd
Subiaco, WA, 6008
Country 5780 0
Australia
Phone 5780 0
+61 8 9340 1456
Fax 5780 0
Email 5780 0
jpillow@meddent.uwa.edu.au

No information has been provided regarding IPD availability
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