Surfactant Administration by Supraglottic Airway for Preterm Infants with Respiratory Distress Syndrome: The SURFSUP 1 Trial

Not Applicable

Recruiting

• Conditions: Respiratory distress syndrome of prematurity; Reproductive Health and Childbirth - Complications of newborn; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620001184965
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-09
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Infants are eligible for inclusion in the trial if they meet all of the following criteria:
-Born preterm at less than 37 weeks’ gestation
-Birth weight 1250 g or above
-Age less than 48 hours
-Diagnosis of RDS, confirmed with chest x-ray or lung ultrasound, except where treatment is required urgently and would be delayed by imaging
-Required FiO2 0.30 or above to maintain target SpO2, on non-invasive respiratory support (CPAP/NIPPV or nHF)

Exclusion Criteria

Infants are excluded from eligibility if they meet any of the following criteria:
-Previous treatment with surfactant or mechanical ventilation via an endotracheal tube
-Urgent need for intubation and mechanical ventilation as determined by the treating clinician
-Urgent need for surfactant prior to eligibility and consent criteria being met
-Known pneumothorax
-Major congenital anomaly of lungs, heart, or airway
-Not receiving full active intensive care (i.e. palliative/comfort care)

Study & Design

• Study Type: Interventional
• Study Design: Not specified