Preventing Lung Disease Using Surfactant + Steroid (The PLUSS Trial)

Phase 3

Active, not recruiting

• Conditions: Bronchopulmonary dysplasia; Extremely preterm birth; Respiratory distress syndrome; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12617000322336
• Lead Sponsor: The Melbourne Children's Trial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-28
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1061

Inclusion Criteria

1.Infants inborn or outborn (and transferred to a particpating centre) at < 28 weeks’ gestation (completed weeks) and admitted to a participating neonatal intensive care unit (NICU) for intensive care AND
2. Receiving respiratory support:defined as mechanical ventilation via an endotracheal tube, or non-invasive ventilation including continuous positive airway pressure (CPAP) , nasal intermittent positive pressure ventilation (NIPPV), or nasal high-flow therapy (nHF) AND a clinician decision to administer surfactant AND
3. Infants are < 48 hours of age

Exclusion Criteria

1. More than one prior surfactant dose
2. Prior treatment with postnatal corticosteroids for the prevention of lung disease (inhaled, nebulised, intratracheal, or systemic)
3. The infant is considered unlikely to survive the immediate postnatal transition and/or is not going to be admitted to the NICU
4. Known or suspected major congenital anomaly that is likely to affect respiratory status including a postnatal clinical diagnosis of severe pulmonary hypoplasia following premature prolonged rupture of fetal membranes with resultant severe oligo- or anhydramnios, where the clinician feels survival is unlikely
5. The infant is likely to be transferred to a non-participating NICU within 24 h of birth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified