OPTIMIST-B trial

Study participants

Preterm infants 29-32 weeks gestation, age <12 hrs

Entry criteria

  1. Requiring CPAP or nasal IPPV because of respiratory distress.
  2. CPAP pressure of 5-8 cm H2O and FiO2 ≥0.30.
  3. Agreement of the Treating Physician in charge of the infant's care.
  4. Signed parental consent.

Exclusion criteria

  1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis.
  2. Congenital anomaly or condition that might adversely affect breathing.
  3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia).
  4. Lack of availability of an OPTIMIST treatment team.

Randomisation

With parental consent, eligible infants will be randomly allocated to receive exogenous surfactant via MIST, or to continue on CPAP.

Intervention

Infants randomised to surfactant treatment will receive a dose of surfactant (CurosurfTM, Chiesi Farmaceutici) administered via the Hobart method of MIST at a dosage of 100 mg/kg. CPAP will thereafter be reinstituted. Controls will continue on CPAP. The intervention will be masked from the clinical team.

Post-intervention management

Other than the requirement to adhere to intubation criteria, management after intervention will be at the discretion of the clinical team. Enrolled infants on CPAP will be intubated if FiO2 ≥0.45 or if there is unremitting apnoea or persistent acidosis.

A room air trial will be conducted in selected infants at 36 weeks corrected gestational age.

Primary outcome

Duration of respiratory support (intubation + CPAP + high flow nasal cannula)

Secondary outcomes

Incidence of death, major neonatal morbidities (CLD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of each form of mechanical respiratory support, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure.

Sample size

448 infants (224 per group), giving 90% power to detect a 25% reduction in duration of respiratory support from an anticipated 4.0 days in the control arm, α = 05.

Trial plan

Large scale funding is being sought for the OPTIMIST-B trial, and the trial will not commence until such funding has been obtained.

Back to top