Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000290594
Ethics application status
Approved
Date submitted
25/10/2004
Date registered
25/10/2004
Date last updated
2/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of lung lavage in meconium aspiration syndrome
Scientific title
A randomised controlled trial of therapeutic lung lavage to reduce the duration of respiratory support required by ventilated newborn infants with meconium aspiration syndrome (MAS)
Secondary ID [1] 59 0
Perinatal Trials Registry: PTR535
Universal Trial Number (UTN)
Trial acronym
lessMAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meconium aspiration syndrome 55 0
Condition category
Condition code
Reproductive Health and Childbirth 62 62 0 0
Complications of newborn
Respiratory 63 63 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lung lavage with 30 ml/kg surfactant solution (5mgs/ml), administered in 2 aliquots, each lasting 1 minute (under 10 minutes for entire procedure), within 24 hours after birth.
Intervention code [1] 1111 0
Treatment: Other
Comparator / control treatment
Standard care of the ventilated neonate with meconium aspiration syndrome
Control group
Active

Outcomes
Primary outcome [1] 94 0
Total duration of respiratory support (ventilation plus nasal continuous positive airway pressure) during initial hospitalisation
Timepoint [1] 94 0
First hospitalisation
Secondary outcome [1] 186 0
Mortality
Timepoint [1] 186 0
First hospitalisation
Secondary outcome [2] 187 0
Incidence of pneumothorax
Timepoint [2] 187 0
First hospitalisation
Secondary outcome [3] 188 0
Duration of oxygen therapy
Timepoint [3] 188 0
First hospitalisation
Secondary outcome [4] 189 0
Intubation and hospitalisation
Timepoint [4] 189 0
First hospitalisation
Secondary outcome [5] 190 0
Respiratory morbidity
Timepoint [5] 190 0
In 1st year pf life.
Secondary outcome [6] 191 0
Neurodevelopmental outcome
Timepoint [6] 191 0
At 2 years.

Eligibility
Key inclusion criteria
Neonates (males and females)with confirmed diagnosis of meconium aspiration syndrome with all of the following:1. birth weight >2.0kgs, gestation >36 weeks.2. <24 hours of age3. ventilated with mean airway pressure >/= 12 cm H2O4. Alveolar-arterial oxygen difference >/= 450 mmHg
Minimum age
0 Days
Maximum age
1 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known or suspected cardiac abnormality. Severe hypoxic ischaemic encephalopathy or congenital anomaly (ie, withdrawal of treatment being considered). Intractable cardiorespiratory instability.

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, variable block size; stratified allocation by study centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2003
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
26/09/2008
Date of last data collection
Anticipated
Actual
27/09/2010
Sample size
Target
66
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment outside Australia
Country [1] 328 0
New Zealand
State/province [1] 328 0

Funding & Sponsors
Funding source category [1] 94 0
Government body
Name [1] 94 0
National Health & Medical Research Council
Country [1] 94 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Dargaville
Address
Royal Hobart Hospital
Liverpool St
Hobart
TAS 7000
Country
Australia
Secondary sponsor category [1] 71 0
None
Name [1] 71 0
nil
Address [1] 71 0
Country [1] 71 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 609 0
Royal Children's Hospital
Ethics committee address [1] 609 0
Ethics committee country [1] 609 0
Australia
Date submitted for ethics approval [1] 609 0
Approval date [1] 609 0
25/02/2003
Ethics approval number [1] 609 0
Ethics committee name [2] 610 0
Royal Women's Hospital
Ethics committee address [2] 610 0
Ethics committee country [2] 610 0
Australia
Date submitted for ethics approval [2] 610 0
Approval date [2] 610 0
Ethics approval number [2] 610 0
Ethics committee name [3] 611 0
Mercy Hospital fpr Women
Ethics committee address [3] 611 0
Ethics committee country [3] 611 0
Australia
Date submitted for ethics approval [3] 611 0
Approval date [3] 611 0
Ethics approval number [3] 611 0
Ethics committee name [4] 612 0
Women's and Children's Hospital Adelaide
Ethics committee address [4] 612 0
Ethics committee country [4] 612 0
Australia
Date submitted for ethics approval [4] 612 0
Approval date [4] 612 0
Ethics approval number [4] 612 0
Ethics committee name [5] 613 0
Royal Hobart Hospital
Ethics committee address [5] 613 0
Ethics committee country [5] 613 0
Australia
Date submitted for ethics approval [5] 613 0
Approval date [5] 613 0
Ethics approval number [5] 613 0
Ethics committee name [6] 614 0
Westmead Hospital
Ethics committee address [6] 614 0
Ethics committee country [6] 614 0
Australia
Date submitted for ethics approval [6] 614 0
Approval date [6] 614 0
Ethics approval number [6] 614 0
Ethics committee name [7] 615 0
Royal Hospital for Women
Ethics committee address [7] 615 0
Ethics committee country [7] 615 0
Australia
Date submitted for ethics approval [7] 615 0
Approval date [7] 615 0
Ethics approval number [7] 615 0
Ethics committee name [8] 616 0
Royal Brisbane and Women's Hospital
Ethics committee address [8] 616 0
Ethics committee country [8] 616 0
Australia
Date submitted for ethics approval [8] 616 0
Approval date [8] 616 0
Ethics approval number [8] 616 0
Ethics committee name [9] 617 0
Royal Darwin Hospital
Ethics committee address [9] 617 0
Ethics committee country [9] 617 0
Australia
Date submitted for ethics approval [9] 617 0
Approval date [9] 617 0
Ethics approval number [9] 617 0
Ethics committee name [10] 618 0
Middlemore Hospital
Ethics committee address [10] 618 0
Ethics committee country [10] 618 0
New Zealand
Date submitted for ethics approval [10] 618 0
Approval date [10] 618 0
Ethics approval number [10] 618 0
Ethics committee name [11] 619 0
National Women's Hospital Auckland
Ethics committee address [11] 619 0
Ethics committee country [11] 619 0
New Zealand
Date submitted for ethics approval [11] 619 0
Approval date [11] 619 0
Ethics approval number [11] 619 0
Ethics committee name [12] 620 0
Wellington Hospital
Ethics committee address [12] 620 0
Ethics committee country [12] 620 0
New Zealand
Date submitted for ethics approval [12] 620 0
Approval date [12] 620 0
Ethics approval number [12] 620 0
Ethics committee name [13] 621 0
KK Women's and Children's Hospital Singapore
Ethics committee address [13] 621 0
Ethics committee country [13] 621 0
Singapore
Date submitted for ethics approval [13] 621 0
Approval date [13] 621 0
Ethics approval number [13] 621 0
Ethics committee name [14] 622 0
Singapore General Hospital
Ethics committee address [14] 622 0
Ethics committee country [14] 622 0
Singapore
Date submitted for ethics approval [14] 622 0
Approval date [14] 622 0
Ethics approval number [14] 622 0
Ethics committee name [15] 623 0
Ipoh Hospital
Ethics committee address [15] 623 0
Ethics committee country [15] 623 0
Malaysia
Date submitted for ethics approval [15] 623 0
Approval date [15] 623 0
Ethics approval number [15] 623 0
Ethics committee name [16] 624 0
HUKM Kuala Lumpur
Ethics committee address [16] 624 0
Ethics committee country [16] 624 0
Malaysia
Date submitted for ethics approval [16] 624 0
Approval date [16] 624 0
Ethics approval number [16] 624 0
Ethics committee name [17] 625 0
Selayang Hospital
Ethics committee address [17] 625 0
Ethics committee country [17] 625 0
Malaysia
Date submitted for ethics approval [17] 625 0
Approval date [17] 625 0
Ethics approval number [17] 625 0
Ethics committee name [18] 626 0
Saitama Medical Centre
Ethics committee address [18] 626 0
Ethics committee country [18] 626 0
Japan
Date submitted for ethics approval [18] 626 0
Approval date [18] 626 0
Ethics approval number [18] 626 0
Ethics committee name [19] 627 0
Taipei Veterans General Hospital
Ethics committee address [19] 627 0
Ethics committee country [19] 627 0
Taiwan
Date submitted for ethics approval [19] 627 0
Approval date [19] 627 0
Ethics approval number [19] 627 0

Summary
Brief summary
Meconium aspiration syndrome (MAS) is a complex disease of the newborn lung that can cause life-threatening respiratory distress very soon after birth. Current management consists mainly of providing supportive care, rather than removing meconium from the lung to hault or slow disease progression. This multicentre randomised controlled trial will test whether therapeutic lung lavage, using a dilute surfactant preparation, improves outcomes in infants with severe MAS. The study will include a total of 66 newborn infants, who are receiving mechanical ventilation because of MAS. The main outcome measure will be duration of respiratory support; secondary outcomes will be duration of oxygen therpay; duration of hospitalisation, and evidence of chronic lung disease.
Trial website
Trial related presentations / publications
Dargaville PA, Copnell B, Mills JF, Haron I, Lee JKF, Tingay DG, Rohana J, Mildenhall LF, Jeng MJ, Narayanan A, Battin MR, Kuschel CA, Sadowsky JL, Patel H, Kilburn CJ, Carlin JB, Morley CJ, for the lessMAS trial study group. Randomized controlled trial of lung lavage with dilute surfactant for meconium aspiration syndrome. J Pediatr (2011); 158: 383-389.

Dargaville PA, Copnell B, Mills JF, Haron I, Lee JKF, Tingay DG, Rohana J, Mildenhall LF, Jeng MJ, Narayanan A, Battin MR, Kuschel CA, Sadowsky JL, Patel H, Kilburn CJ, Carlin JB, Morley CJ, for the lessMAS trial study group. Fluid recovery during lung lavage in meconium aspiration syndrome. Acta Paediatrica (2013); 102: e90-e93.
Public notes

Contacts
Principal investigator
Name 36058 0
Prof Peter Dargaville
Address 36058 0
Dept of Paediatrics
Royal Hobart Hospital
Hobart
TAS 7000
Country 36058 0
Australia
Phone 36058 0
+61 361667546
Fax 36058 0
Email 36058 0
[email protected]
Contact person for public queries
Name 10300 0
Prof Peter Dargaville
Address 10300 0
Dept of Paediatrics
Royal Hobart Hospital
Liverpool St
Hobart
TAS 7000
Country 10300 0
Australia
Phone 10300 0
+61 361667546
Fax 10300 0
03 62264864
Email 10300 0
[email protected]
Contact person for scientific queries
Name 1228 0
Prof Peter Dargaville
Address 1228 0
Dept of Paediatrics
Royal Hobart Hospital
Liverpool St
Hobart
TAS 7000
Country 1228 0
Australia
Phone 1228 0
+61 361667546
Fax 1228 0
No fax
Email 1228 0
[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.