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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02140580
Registration number
NCT02140580
Ethics application status
Date submitted
13/05/2014
Date registered
16/05/2014
Date last updated
1/05/2020
Titles & IDs
Public title
OPTIMIST-A Trial: Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on CPAP
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Scientific title
Multicentre Randomised Controlled Trial of Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on Continuous Positive Airways Pressure
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Secondary ID [1]
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4.3, 6th June 2013
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Universal Trial Number (UTN)
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Trial acronym
OPTIMIST-A
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchopulmonary Dysplasia
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Reproductive Health and Childbirth
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Minimally invasive surfactant therapy
Other interventions - Continuation on CPAP
Active Comparator: Minimally invasive surfactant therapy - 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. Poractant alfa (Curosurf) at a dosage of 200 mg/kg will be administered over 15 - 30 seconds. Total duration of the procedure will be less than 5 minutes, followed by reinstitution of CPAP.
Sham Comparator: Continuation on CPAP - 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 intubation equipment, screening the baby, testing suction unit, repositioning of the baby and changing the baby's monitoring. CPAP will thereafter continue.
Treatment: Devices: Minimally invasive surfactant therapy
Active Comparator
Other interventions: Continuation on CPAP
Sham Comparator
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death or physiological bronchopulmonary dysplasia
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Assessment method [1]
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Composite outcome of death by 36 weeks or physiological bronchopulmonary dysplasia (BPD). Physiological BPD is assessed at 36 weeks post-menstrual age, and is defined as either need for respiratory support (intubation / CPAP / high flow nasal cannula > 2 L/min) or need for FiO2 >=0.3 or failure of a room air trial conducted at 36 weeks post-menstrual age. This will be assessed by the research nurse at each centre.
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Timepoint [1]
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36 weeks post menstrual age
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Timepoint [1]
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36 weeks post menstrual age
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Secondary outcome [2]
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Major morbidity
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Assessment method [2]
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Major morbidity, defined as one or more of BPD, grade III or IV intraventricular haemorrhage, periventricular leukomalacia or retinopathy of prematurity > stage 2, occurring at any time up to 36 weeks post menstrual age. Screening for intraventricular haemorrhage, periventricular leukomalacia and retinopathy of prematurity will be performed as routine care, and the results taken from the medical record.
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Timepoint [2]
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36 weeks post menstrual age
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Secondary outcome [3]
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Pneumothorax
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Assessment method [3]
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Pneumothorax at any time up to 36 weeks post menstrual age, as documented in medical record.
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Timepoint [3]
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36 weeks post menstrual age
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Secondary outcome [4]
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Duration of respiratory support
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Assessment method [4]
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Duration of respiratory support, defined as cumulative hours of all episodes of intubation, nasal CPAP and high flow nasal cannula oxygen (flow rate >= 2 litres/min). This information will be derived from medical record or unit database.
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Timepoint [4]
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During first hospitalisation (average assessment period 14 weeks)
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Secondary outcome [5]
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Bronchopulmonary dysplasia
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Assessment method [5]
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Bronchopulmonary dysplasia (BPD) will be assessed both clinically (need for mechanical respiratory support and/or an oxygen requirement at 36 weeks corrected gestation), and by a physiological definition. Physiological BPD is assessed at 36 weeks post-menstrual age, and is defined as either need for respiratory support (intubation / CPAP / high flow nasal cannula > 2 L/min) or need for FiO2 >=0.3 or failure of a room air trial conducted at 36 weeks post-menstrual age. This will be assessed by the research nurse at each centre.
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Timepoint [5]
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36 weeks post menstrual age
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Secondary outcome [6]
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Duration of bradycardia and hypoxaemia during intervention
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Assessment method [6]
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Heart rate and oxygen saturation will be monitored continuously during the intervention. The severity and duration of bradycardia and hypoxia will thus be documented during delivery of exogenous surfactant via brief tracheal catheterisation.
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Timepoint [6]
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During intervention
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Secondary outcome [7]
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Discomfort during intervention
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Assessment method [7]
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The incidence of apparent discomfort, as judged by the nurse assisting in the surfactant delivery procedure, will be ascertained in the group randomised to receive surfactant via brief tracheal catheterisation.
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Timepoint [7]
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During intervention
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Eligibility
Key inclusion criteria
- Gestational age 25-28 completed weeks
- Requiring CPAP or non-invasive positive pressure ventilation with signs of early
respiratory distress.
- CPAP pressure of 5-8 cm H2O and FiO2 >=0.30.
- Less than 6 hours of age.
- Agreement of the Treating Physician in charge of the infant's care.
- Signed parental consent.
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Minimum age
1
Minute
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Maximum age
6
Hours
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Previously intubated, or in imminent need of intubation
- Congenital anomaly or condition that might adversely affect breathing.
- Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or
pulmonary hypoplasia).
- Lack of availability of an OPTIMIST treatment team.
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Study design
Purpose of the study
Supportive Care
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
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Accrual to date
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Final
486
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Recruitment in Australia
Recruitment state(s)
TAS,VIC
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Recruitment hospital [1]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [2]
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Royal Womens Hospital - Melbourne
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Recruitment hospital [3]
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Mercy Hospital for Women - Melbourne
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Recruitment hospital [4]
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Monash Medical Centre - Melbourne
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Recruitment postcode(s) [1]
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7000 - Hobart
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Recruitment postcode(s) [2]
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3052 - Melbourne
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment postcode(s) [4]
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3168 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Connecticut
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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New Jersey
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United States of America
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West Virginia
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Country [6]
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Israel
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State/province [6]
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Haifa
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Israel
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State/province [7]
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Tsefat
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New Zealand
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State/province [8]
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Auckland
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Country [9]
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Slovenia
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State/province [9]
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Ljubljana
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Turkey
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State/province [10]
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Bursa
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Country [11]
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Turkey
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State/province [11]
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Ankara
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Funding & Sponsors
Primary sponsor type
Other
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Name
Menzies Institute for Medical Research
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Royal Hobart Hospital
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Address [1]
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Other
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Name [2]
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Royal Women's Hospital, Melbourne, Australia
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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NorthShore University HealthSystem
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Other
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Monash Medical Centre
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Other
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Mercy Hospital for Women, Australia
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Other collaborator category [6]
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Other
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Auckland City Hospital
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Other
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Middlemore Hospital, New Zealand
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Other collaborator category [8]
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Other
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Zekai Tahir Burak Women's Health Research and Education Hospital
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Other
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Kapiolani Medical Center For Women & Children
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Other
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The Cooper Health System
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Other
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Yale University
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Other
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West Virginia University Hospital
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Other
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Uludag University Hospital
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Other
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Ziv Medical Center
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Other
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Bnai Zion Medical Center
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Other
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University Medical Centre Ljubljana
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Other
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Dunedin Hospital
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Other
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Kanuni Sultan Suleyman Training and Research Hospital
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Other collaborator category [19]
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Other
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University Medical Center Groningen
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Other collaborator category [20]
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Other
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University of Southern California
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Ethics approval
Ethics application status
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Summary
Brief summary
Trial question: Does administration of exogenous surfactant using a minimally-invasive
technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous
positive airway pressure (CPAP)? Trial hypothesis: That early surfactant administration via a
minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of
mechanical respiratory support, and a higher incidence of survival without bronchopulmonary
dysplasia. Trial design: Multicentre, randomised, masked, controlled trial in inborn preterm
infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory
distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant
treatment receive 200 mg/kg of poractant alfa (Curosurf) administered under direct
laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP.
Controls continue on CPAP. The intervention is masked from the clinical team. Care thereafter
is as per usual in both groups, other than the requirement to adhere to intubation criteria.
The primary outcome is incidence of death or BPD. Secondary outcomes include incidence of
death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular
leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent
ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical
respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC),
oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability
and safety of the MIST procedure; and outcome at 2 years. The sample size is 303/group,
allowing detection of a 33% difference in the primary outcome with 90% power. The trial
commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and
will ultimately be conducted over 5 years in multiple centres internationally.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02140580
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Trial related presentations / publications
Dargaville PA, Aiyappan A, De Paoli AG, Kuschel CA, Kamlin CO, Carlin JB, Davis PG. Minimally-invasive surfactant therapy in preterm infants on continuous positive airway pressure. Arch Dis Child Fetal Neonatal Ed. 2013 Mar;98(2):F122-6. doi: 10.1136/archdischild-2011-301314. Epub 2012 Jun 9.
Dargaville PA, Aiyappan A, Cornelius A, Williams C, De Paoli AG. Preliminary evaluation of a new technique of minimally invasive surfactant therapy. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F243-8. doi: 10.1136/adc.2010.192518. Epub 2010 Oct 21.
Dargaville PA. Innovation in surfactant therapy I: surfactant lavage and surfactant administration by fluid bolus using minimally invasive techniques. Neonatology. 2012;101(4):326-36. doi: 10.1159/000337346. Epub 2012 Jun 1.
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Public notes
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Contacts
Principal investigator
Name
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Peter A Dargaville, MD
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Address
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Menzies Institute of Medical Research, University of Tasmania
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02140580
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