OPTIMIST-A Trial: Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on CPAP (OPTIMIST-A)
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|ClinicalTrials.gov Identifier: NCT02140580|
Recruitment Status : Unknown
Verified April 2020 by Professor Peter Dargaville, Menzies Institute for Medical Research.
Recruitment status was: Active, not recruiting
First Posted : May 16, 2014
Last Update Posted : May 1, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Bronchopulmonary Dysplasia||Device: Minimally invasive surfactant therapy Other: Continuation on CPAP||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||486 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multicentre Randomised Controlled Trial of Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on Continuous Positive Airways Pressure|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2022|
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.
Device: Minimally invasive surfactant therapy
Other Name: 16G Angiocath, Product No. 382259, BD, Sandy, UT, USA
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.
Other: Continuation on CPAP
Other Name: Standard care - continuation of CPAP
- Death or physiological bronchopulmonary dysplasia [ Time Frame: 36 weeks post menstrual age ]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.
- Mortality [ Time Frame: 36 weeks post menstrual age ]
- Major morbidity [ Time Frame: 36 weeks post menstrual age ]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.
- Pneumothorax [ Time Frame: 36 weeks post menstrual age ]Pneumothorax at any time up to 36 weeks post menstrual age, as documented in medical record.
- Duration of respiratory support [ Time Frame: During first hospitalisation (average assessment period 14 weeks) ]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.
- Bronchopulmonary dysplasia [ Time Frame: 36 weeks post menstrual age ]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.
- Duration of bradycardia and hypoxaemia during intervention [ Time Frame: During intervention ]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.
- Discomfort during intervention [ Time Frame: During intervention ]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.
- Hospitalisation cost [ Time Frame: First hospitalisation (average assessment period 14 weeks) ]The mean of patient billings and mean cost of hospitalisation per patient will be determined, and compared between groups.
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|Ages Eligible for Study:||1 Minute to 6 Hours (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140580
|United States, Connecticut|
|Yale-New Haven Children's Hospital|
|New Haven, Connecticut, United States, 06520-8081|
|United States, Hawaii|
|Kapi'olani Medical Center for Women and Children|
|Honolulu, Hawaii, United States, 96826|
|United States, Illinois|
|NorthShore Health University HealthSystem Evanston Hospital|
|Evanston, Illinois, United States, 60201|
|United States, New Jersey|
|Cooper University Hospital|
|Camden, New Jersey, United States, 08103|
|United States, West Virginia|
|West Virginia University Hospital|
|Morgantown, West Virginia, United States, 26506|
|Royal Hobart Hospital|
|Hobart, Tasmania, Australia, 7000|
|Royal Womens Hospital|
|Melbourne, Victoria, Australia, 3052|
|Mercy Hospital for Women|
|Melbourne, Victoria, Australia, 3084|
|Monash Medical Centre|
|Melbourne, Victoria, Australia, 3168|
|Bnai Zion Medical Center|
|Haifa, Israel, 31048|
|Ziv Medical Center|
|Tsefat, Israel, 13100|
|Auckland City Hospital|
|Auckland, New Zealand, 1142|
|Auckland, New Zealand, 1640|
|University Medical Center, Ljubljana|
|Zaloska, Ljubljana, Slovenia, SI-1525|
|Uludag University Hospital|
|Gorukle, Bursa, Turkey, 16120|
|Zekai Tahir Burak Hospital|
|Ankara, Turkey, 06230|
|Principal Investigator:||Peter A Dargaville, MD||Menzies Institute of Medical Research, University of Tasmania|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Professor Peter Dargaville, Consultant Neonatologist, Paediatric and Neonatal Intensive Care Unit, Royal Hobart Hospital, Menzies Institute for Medical Research|
|Other Study ID Numbers:||
4.3, 6th June 2013
|First Posted:||May 16, 2014 Key Record Dates|
|Last Update Posted:||May 1, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Minimally-invasive surfactant therapy
Ventilator-Induced Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Respiratory System Agents