Optimist-A Trial underway at University Hospital of Wales

By Annabel Greenwood

The Neonatal Unit at UHW are currently participating in the ‘Optimist-A Trial’ and I thought this would be the perfect platform to raise awareness and explain briefly about the trial…
 
What is it?
An international multicentre randomised controlled trial of surfactant administration whilst on CPAP, in preterm infants 25-28/40 gestation.
 
Research Question
Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants treated with continuous positive airway pressure (CPAP)?
 
Why is it important?
Premature babies ( ≤28 weeks gestation) with significant surfactant deficiency on CPAP have historically required intubation for the administration of surfactant therapy, with subsequent increased associated risk of death, bronchopulmonary dysplasia (BPD) and other morbidities.
In an attempt to address this problem, minimally-invasive surfactant therapy (MIST) techniques have been developed whereby exogenous surfactant is administered via an instillation catheter, inserted briefly into the trachea under direct laryngoscopy, whilst on CPAP.
 
Eligibility Criteria

• Inborn preterm infants 25-28/40 gestation
• Age < 6 hours
• On CPAP due to RDS
• FiO2 ≥ 0.30

 
Randomisation
Eligible infants will be randomly allocated to receive exogenous surfactant via MIST, or continue on CPAP.
 
Intervention

• Curosurf administration (200mg/kg) via brief tracheal catheterisation under direct visualisation, followed by recommencement of CPAP.
• Controls continue on CPAP
• Intervention is masked from the clinical team

Primary Outcome

• Death or BPD at 36/40 corrected gestation

Secondary Outcomes

• Incidence of major neonatal morbidities (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
• Outcome at 2 years

 
Any further queries?
Contact Rachel Hayward Neonatal SpR at UHW, for any further information (Rachel.hayward@doctor.org.uk)