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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 : Recruiting
First Posted : May 16, 2014
Last Update Posted : July 6, 2016
Sponsor:
Collaborators:
Royal Hobart Hospital
Royal Women's Hospital, Melbourne, Australia
NorthShore University HealthSystem
Monash Medical Centre
Mercy Hospital for Women, Australia
Auckland City Hospital
Middlemore Hospital, New Zealand
Zekai Tahir Burak Women's Health Research and Education Hospital
Kapiolani Medical Center For Women & Children
The Cooper Health System
Yale University
West Virginia University Hospital
Uludag University Hospital
Ziv Medical Center
Bnai Zion Medical Center
University Medical Centre Ljubljana
Dunedin Hospital
Kanuni Sultan Suleyman Training and Research Hospital
University Medical Center Groningen
University of Southern California
Information provided by (Responsible Party):
Professor Peter Dargaville, Menzies Institute for Medical Research

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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Device: Minimally invasive surfactant therapy Other: Continuation on CPAP Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 606 participants
Allocation: Randomized
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 : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Active Comparator
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
Sham Comparator
Other Name: Standard care - continuation of CPAP




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 36 weeks post menstrual age ]
  2. 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.

  3. Pneumothorax [ Time Frame: 36 weeks post menstrual age ]
    Pneumothorax at any time up to 36 weeks post menstrual age, as documented in medical record.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Other Outcome Measures:
  1. 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:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Peter Dargaville, MD +61 361668308 peter.dargaville@ths.tas.gov.au
Contact: Karen Butterley, MN +61 3 61668266 optimist.trials@menzies.utas.edu.au

Locations
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United States, Connecticut
Yale-New Haven Children's Hospital Not yet recruiting
New Haven, Connecticut, United States, 06520-8081
Contact: Richard Ehrenkranz, MD       richard.ehrenkranz@yale.edu   
Principal Investigator: Richard Ehrenkranz, MD         
United States, Hawaii
Kapi'olani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Sheree Kuo, MD       Shereek@kapiolani.org   
Contact: Micah Tong, CCRP    (808) 983-6427    micah.tong@hawaiipacifichealth.org   
Principal Investigator: Sheree Kuo, MD         
Sub-Investigator: Charles Neal, MD         
Sub-Investigator: Venkataraman Balaraman, MD         
United States, Illinois
NorthShore Health University HealthSystem Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: Matthew Derrick, MD    847-570-2045    MDerrick@northshore.org   
Principal Investigator: Matthew Derrick, MD         
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Alla Kushnir, MD       kushnir-alla@CooperHealth.edu   
Contact: Heather Camparri, RN       Camparri-heather@cooperhealth.edu   
Principal Investigator: All Kushnir, MD         
United States, West Virginia
West Virginia University Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mark Polak, MD       mpolak@hsc.wvu.edu   
Principal Investigator: Mark Polak, MD         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7000
Contact: Peter Dargaville, MD    +61 3 61668308    peter.dargaville@ths.tas.gov.au   
Principal Investigator: Tony DePaoli, MD         
Australia, Victoria
Royal Womens Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Contact: Omar Kamlin, MD    +61 3 83453769    omar.kamlin@thewomens.org.au   
Principal Investigator: Omar Kamlin, MD         
Mercy Hospital for Women Recruiting
Melbourne, Victoria, Australia, 3084
Contact: Ajit Aiyappan, MD    +61 3 8458 4736    AAiyappan@mercy.com.au   
Principal Investigator: Ajit Aiyappan, MD         
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3168
Contact: Kenneth Tan, MD    +61 3 9594 6666    Kenneth.Tan@southernhealth.org.au   
Principal Investigator: Kenneth Tan, MD         
Israel
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: David Bader, MD       davidbade@gmail.com   
Principal Investigator: David Bader, MD         
Ziv Medical Center Recruiting
Tsefat, Israel, 13100
Contact: Eric Shinwell, MD       Eric.s@ziv.health.gov.il   
Principal Investigator: Eric Shinwell, MD         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Mariam Buksh, MB BS    +64 9 375 4300    MariamB@adhb.govt.nz   
Principal Investigator: Mariam Buksh, MB BS         
Middlemore Hospital Recruiting
Auckland, New Zealand, 1640
Contact: Lindsay Mildenhall, MD    +6421784022    Lindsay.Mildenhall@middlemore.co.nz   
Principal Investigator: Lindsay Mildenhall, MD         
Slovenia
University Medical Center, Ljubljana Recruiting
Zaloska, Ljubljana, Slovenia, SI-1525
Contact: Lilijana Kornhauser-Cerar, MD       lilijanakornhauser-cerar@guest.arnes.si   
Principal Investigator: Lilijana Kornhauser-Caerar, MD         
Turkey
Uludag University Hospital Recruiting
Gorukle, Bursa, Turkey, 16120
Contact: Merih Cetinkaya, MD       drmerih@yahoo.com   
Principal Investigator: Merih Cetinkaya, MD         
Zekai Tahir Burak Hospital Recruiting
Ankara, Turkey, 06230
Contact: Gozde Kanmaz Kutman, MD    +90 505 5881189    gzdekanmaz@gmail.com   
Contact: Fadik Gokelek, RN       f.kulaksiz@gmail.com   
Principal Investigator: Gozde Kanmaz Kutman, MD         
Sponsors and Collaborators
Menzies Institute for Medical Research
Royal Hobart Hospital
Royal Women's Hospital, Melbourne, Australia
NorthShore University HealthSystem
Monash Medical Centre
Mercy Hospital for Women, Australia
Auckland City Hospital
Middlemore Hospital, New Zealand
Zekai Tahir Burak Women's Health Research and Education Hospital
Kapiolani Medical Center For Women & Children
The Cooper Health System
Yale University
West Virginia University Hospital
Uludag University Hospital
Ziv Medical Center
Bnai Zion Medical Center
University Medical Centre Ljubljana
Dunedin Hospital
Kanuni Sultan Suleyman Training and Research Hospital
University Medical Center Groningen
University of Southern California
Investigators
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Principal Investigator: Peter A Dargaville, MD Menzies Institute of Medical Research, University of Tasmania

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Peter Dargaville, Consultant Neonatologist, Paediatric and Neonatal Intensive Care Unit, Royal Hobart Hospital, Menzies Institute for Medical Research
ClinicalTrials.gov Identifier: NCT02140580     History of Changes
Other Study ID Numbers: 4.3, 6th June 2013
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Professor Peter Dargaville, Menzies Institute for Medical Research:
Minimally-invasive surfactant therapy
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents