OPTIMIST-A Trial: Minimally-invasive Surfactant Therapy in Preterm Infants 25-28 Weeks Gestation on CPAP

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID: NCT02140580
Run by: Menzies Institute for Medical Research
People needed: 486
Starts: 2011-12-01
Expected to finish: 2022-06-01
Last updated by the study team: 2020-05-01

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Yale-New Haven Children's Hospital — New Haven, Connecticut, United States
Kapi'olani Medical Center for Women and Children — Honolulu, Hawaii, United States
NorthShore Health University HealthSystem Evanston Hospital — Evanston, Illinois, United States
Cooper University Hospital — Camden, New Jersey, United States
West Virginia University Hospital — Morgantown, West Virginia, United States
Royal Hobart Hospital — Hobart, Tasmania, Australia
Royal Womens Hospital — Melbourne, Victoria, Australia
Mercy Hospital for Women — Melbourne, Victoria, Australia
Monash Medical Centre — Melbourne, Victoria, Australia
Bnai Zion Medical Center — Haifa, Israel
Ziv Medical Center — Safed, Israel
Auckland City Hospital — Auckland, New Zealand
Middlemore Hospital — Auckland, New Zealand
University Medical Center, Ljubljana — Zaloska, Ljubljana, Slovenia
Uludag University Hospital — Görükle, Bursa, Turkey (Türkiye)
Zekai Tahir Burak Hospital — Ankara, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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