ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000917932

Ethics application status

Approved

Date submitted

25/08/2011

Date registered

26/08/2011

Date last updated

11/11/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 29-32 weeks gestation on continuous positive airway pressure

Scientific title

Multicentre randomised controlled trial in preterm infants 29-32 weeks gestation on continuous positive airway pressure of the effect of minimally-invasive surfactant therapy in comparison to standard care (continuation of CPAP) on the duration of respiratory support (all hours of intubation, nasal CPAP and high flow nasal cannula).

Secondary ID [1]

nil

Universal Trial Number (UTN)

Trial acronym

OPTIMIST-B

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neonatal respiratory distress syndrome

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Minimally invasive surfactant therapy - delivery of exogenous surfactant to the lung via brief catheterisation of the trachea with an instillation catheter in a preterm infant who is being supported with continuous positive airway pressure (CPAP) via nasal prongs or mask. The surfactant dose will be 100 mg/kg, administered over 15 - 30 seconds. Total duration of the procedure will be less than 5 minutes, followed by reinstitution of CPAP. Only a single dose will be given within the first 12 hours of life.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Continued treatment with nasal CPAP delivered by prongs or mask. This is the standard control treatment. After randomisation, infants will receive a sham treatment from a treatment team not engaged in clinical care. This will not involve removal of prongs or discontinuation of CPAP but will require setting up equipment, screening baby, repositioning baby, use of suctioning equipment and change of monitoring.

Control group

Placebo

Outcomes

Primary outcome [1]

Duration of respiratory support, including all hours of intubation, nasal CPAP and high flow nasal cannula support (flow rate > 2 L/min). This will be assessed by the research nurse at each centre.

Timepoint [1]

During first hospitalisation

Secondary outcome [1]

Mortality

Timepoint [1]

During first hospitalisation

Secondary outcome [2]

Major morbidity, defined as one or more of BPD, grade III or IV intraventricular haemorrhage, periventricular leukomalacia or retinopathy of prematurity > stage 2. Screening for intraventricular haemorrhage, periventricular leukomalacia and retinopathy of prematurity will be performed as routine care, and the results taken from the medical record.

Timepoint [2]

During first hospitalisation

Secondary outcome [3]

Pneumothorax, as documented in medical record

Timepoint [3]

During first hospitalisation

Secondary outcome [4]

Cost of hospitalisation assessed by computation of length of stay and level of acuity.

Timepoint [4]

During first hospitalisation

Eligibility

Key inclusion criteria

1. Gestational age 29-32 completed weeks
2. Requiring CPAP with signs of early respiratory distress.
3. CPAP pressure of 5-6 cm H2O and FiO2 >=0.32, or a CPAP pressure 7-8 cm H2O and FiO2 >=0.28.
4. Less than 12 hours of age.
5. Agreement of the Treating Physician in charge of the infant’s care.
6. Signed parental consent.

Minimum age

0 Hours

Maximum age

12 Hours

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis.
2. Congenital anomaly or condition that might adversely affect breathing.
3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia).
4. Lack of availability of an OPTIMIST treatment team.

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)

Preterm infants of gestation 29 weeks 0 days - 32 weeks 6 days who fulfill the entry criteria will be enrolled once written parental consent has been obtained by the treating clinicians. The infant will be randomised by the OPTIMIST Treatment Team, after handover of care from the treating clinicians. A web-based central randomisation program will allocate infants into “surfactant via MIST” and “standard care” groups, with an allocation ratio of 1:1. Twins and higher order multiples will be randomised independently.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation schedule and web-based
service will be provided by the Clinical Epidemiology and Biostatistics Unit at the Murdoch Childrens Research Institute. The randomisation will be in randomly permuted blocks of variable length, stratified by study centre, and by gestational age. For each trial there will be two gestational
age strata 29-30 weeks and 31-32 weeks.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2017

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

454

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Royal Hobart Hospital Research Foundation

Address [1]

Royal Hobart Hospital Liverpool St Hobart TAS 7000

Country [1]

Australia

Primary sponsor type

University

Name

Menzies Institute of Medical Research, University of Tasmania

Address

17 Liverpool Street
Hobart TAS 7000

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Tasmania

Address [1]

Sandy Bay Rd., Sandy Bay Hobart TAS 7005

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

Royal Hobart Hospital

Address [1]

Liverpool St Hobart TAS 7000

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Royal Women's Hospital

Address [2]

Flemington Rd., Parkville VIC 3052

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private Bag 1
Hobart
Tasmania
7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/06/2011

Ethics approval number [1]

H11616

Summary

Brief summary

Research question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 29-32 weeks gestation treated with continuous positive airway pressure (CPAP)? 

A multicentre, randomised, masked, controlled trial will be conducted in preterm infants 29-32 weeks gestation, aged less than 12 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.32 (CPAP pressure 5-6) or >=0.28 (CPAP pressure 7-8). Infants randomised to surfactant treatment will receive 100 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. 

Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be duration of respiratory support (all hours of intubation, CPAP and high flow nasal cannula). Secondary outcomes will include Need for intubation and surfactant therapy; durations of intubation, CPAP, intubation and CPAP, HFNC, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; incidence of death, major neonatal morbidities, pneumothorax and patent ductus arteriosus; and applicability and safety of the MIST procedure.

The sample size will be 227/group, allowing detection of a 25% reduction in duration of respiratory support with 90% power. 

The trial will commence at Royal Hobart Hospital and Royal Women's Hospital during 2011, and will ultimately be conducted over 5 years in multiple centres nationally and overseas.

Trial website

Trial related presentations / publications

Dargaville PA, Aiyappan A, De Paoli AG, et al. CPAP failure in preterm infants defines a group at high risk of adverse outcome (abstract). E-PAS 2011: 4529.412.

Dargaville PA, Aiyappan A, De Paoli AG, et al. Minimally invasive surfactant therapy in preterm infants on CPAP (abstract). E-PAS 2011: 4530.430.

Dargaville PA, Aiyappan A, Cornelius A, et al. Preliminary evaluation of a new technique of minimally invasive surfactant therapy. Arch Dis Child Fetal Neonatal Ed 2011; 96: F243-8.

Public notes

Contacts

Principal investigator

Name

Prof Peter Dargaville

Address

Department of Paediatrics Royal Hobart Hospital Liverpool St., Hobart Tasmania 7000

Country

Australia

Phone

+61 3 62228308

Fax

[email protected]

Contact person for public queries

Name

Peter Dargaville

Address

Royal Hobart Hospital Liverpool St Hobart TAS 7000

Country

Australia

Phone

+61 3 62227546

Fax

[email protected]

Contact person for scientific queries

Name

Peter Dargaville

Address

Royal Hobart Hospital Liverpool St Hobart TAS 7000

Country

Australia

Phone

+61 3 62227546

Fax

[email protected]

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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically