Trial Synopsis

Trial Title

Multicentre Randomised Controlled Trial of Surfactant Plus Budesonide to Improve Survival Free of Bronchopulmonary Dysplasia in Extremely Preterm Infants

The PLUSS TRIAL - Preventing Lung Disease Using Surfactant + Steroid

Objectives

The PLUSS trial aims to answer the important question Does administration of intra-tracheal budesonide during the early treatment of respiratory distress syndrome (RDS) in extremely preterm infants increase survival without bronchopulmonary dysplasia (BPD) at 36 weeks’ postmenstrual age (PMA)?

Trial Design

A phase III international multicentre prospective  blinded randomised trial  to be conducted in the neonatal intensive care units in Australia, New Zealand, Canada and Singapore

Trial Outcomes

The primary outcome for the PLUSS trial is the composite outcome of whether death or BPD at 36 weeks Post-Menstrual Age (PMA), as assessed by a standard oxygen reduction test.

Secondary outcomes include

·        Respiratory status at 28 days postnatal

·        Respiratory status at 36 and 40 weeks’ PMA,

·        Presence of Patent ductus arteriosus  

·        Rate of infection

·        Medical assessment at 2 years and into childhood.

Trial Population

Infants born extremely preterm infants at <28 weeks’ gestation who require surfactant to treat respiratory distress

Trial Intervention

Surfactant and Budesonide Group: Infants will receive budesonide (PulmicortTM) mixed with surfactant (Curosurf™).

Surfactant alone Group: Infants will receive surfactant (Curosurf™) alone.

Enrolled, infants will receive at least one, and possibly two doses of surfactant +/- budesonide.

Number of Participants

1060 infants (530 infants per group)

Recruitment Period

Planned recruitment until June 2023

Follow up period

24 months

Trial Registration

Australian New Zealand Clinical Trials Registry; ACTRN12617000322336