ANZCTR - Registration

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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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

Childbirth and postnatal care

Reproductive Health and Childbirth

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]

Treatment: Devices

Intervention code [2]

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]

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]

Need for intubation in first 72 h of life

Primary outcome [2]

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]

Duration of mechanical ventilation at the end of the 1st 72 h of life.

Secondary outcome [1]

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]

Assessments will be made over the period of nebulisation, and again at 72 hours.

Secondary outcome [2]

Physiological stability as determined by respiratory rate, pulse rate, mean blood pressure, FiO2, and blood pH

Timepoint [2]

72 h

Secondary outcome [3]

Number of surfactant treatments administered

Timepoint [3]

72 h

Secondary outcome [4]

Duration of mechanical ventilation

Timepoint [4]

14 d

Secondary outcome [5]

Any airleak syndrome

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/10/2010

Actual

15/10/2010

Date of last participant enrolment

Anticipated

Actual

12/05/2012

Date of last data collection

Anticipated

Actual

28/06/2012

Sample size

Target

110

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

State Health Research Advisory Council of Western Australia (SHRAC)

Address [1]

SHRAC
C/o Research Development Unit
Department of Health

PO Box 8172,
Perth Business Centre, WA 6849

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Women and Infants Research Foundation

Address [2]

c/- Carson House,
King Edward Memorial Hospital,
374 Bagot Rd,
Subiaco, WA, 6008

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Women and Infants Research Foundation

Address [3]

c/- Carson House,
King Edward Memorial Hospital,
374 Bagot Rd,
Subiaco, WA, 6008

Country [3]

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]

University

Name [1]

School of Paediatrics and Child Health (SPACH)

Address [1]

The University of Western Australia
35 Stirling Hwy
CRAWLEY WA 6009

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women and Newborn Health Service (WNHS) Ethics Committee

Ethics committee address [1]

Level 1, 
Children's Clinical
Research Facility (CCRF)
Princess Margaret Hospital
GPO Box D184
Perth WA 6840

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/10/2010

Ethics approval number [1]

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

Prof JJ Pillow

Address

M309, APHB
Hackett Entrance 2,
Hackett Drive, Crawley, 6009, WA

Country

Australia

Phone

+61 864883318

Fax

jane.pillow@uwa.edu.au

Contact person for public queries

Name

Dr Stefan Minocchieri

Address

School of Paediatrics and Child Health
Level 4, Admin Building
Roberts Rd
Subiaco, WA, 6008

Country

Australia

Phone

+61 8 9340 8452

Fax

sminocchieri@meddent.uwa.edu.au

Contact person for scientific queries

Name

Prof JJ Pillow

Address

King Edward Memorial Hospital
Neonatal Special Care Nursery
Bagot Rd
Subiaco, WA, 6008

Country

Australia

Phone

+61 8 9340 1456

Fax

jpillow@meddent.uwa.edu.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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Nebulised surfactant to reduce severity of respiratory distress: A blinded, parallel, randomised controlled trial.	2019	https://dx.doi.org/10.1136/archdischild-2018-315051

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically