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

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

DEVICE

Minimally invasive surfactant therapy

Active Comparator

OTHER

Continuation on CPAP

Sham Comparator

Sponsors & Collaborators

• Royal Hobart Hospital

  collaborator OTHER_GOV

• Royal Women's Hospital, Melbourne, Australia

  collaborator UNKNOWN

• Endeavor Health

  collaborator OTHER

• Monash Medical Centre

  collaborator OTHER

• Mercy Hospital for Women, Australia

  collaborator OTHER

• Auckland City Hospital

  collaborator OTHER_GOV

• Middlemore Hospital, New Zealand

  collaborator OTHER

• Zekai Tahir Burak Women's Health Research and Education Hospital

  collaborator OTHER

• Kapiolani Medical Center For Women & Children

  collaborator OTHER

• The Cooper Health System

  collaborator OTHER

• Yale University

  collaborator OTHER

• West Virginia University Hospital

  collaborator UNKNOWN

• Uludag University Hospital

  collaborator UNKNOWN

• Ziv Medical Center

  collaborator OTHER

• Bnai Zion Medical Center

  collaborator OTHER_GOV

• University Medical Centre Ljubljana

  collaborator OTHER

• Dunedin Hospital

  collaborator OTHER

• Kanuni Sultan Suleyman Training and Research Hospital

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Menzies Institute for Medical Research

  lead OTHER

Principal Investigators

• Peter A Dargaville, MD · Menzies Institute of Medical Research, University of Tasmania

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Minute

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2020-05-31

Completion

2022-06-30

Countries

• United States
• Australia
• Israel
• New Zealand
• Slovenia
• Turkey (Türkiye)

Study Locations