Comparison of INRECSURE and LISA in Preterm Neonates With RDS

Summary

The primary hypothesis of this study is that surfactant administration by INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E), via a high frequency oscillatory ventilation recruitment maneuver increases survival without BPD at 36 weeks' gestational age in spontaneously breathing infants born at 24+0-27+6 weeks' gestation affected by Respiratory Distress Syndrome (RDS) and failing nasal CPAP or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 hours of life compared to less invasive surfactant administration (LISA).

Conditions

• Respiratory Distress Syndrome
• Bronchopulmonary Dysplasia

Interventions

DEVICE

Ventilator for High-frequency Oscillatory Ventilation (HFOV)

This device will be used to perform an HFOV recruitment maneuver before surfactant administration

DEVICE

Less invasive surfactant administration (LISA)

SurfCath™ tracheal instillation catheter, or a 4- 6 F end-hole catheter, according to local protocols will be used for surfactant administration

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University Hospital Schleswig-Holstein

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Policlinico Casilino ASL RMB

  collaborator OTHER

• The University of Western Australia

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Maggiore Hospital Carlo Alberto Pizzardi

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Ospedali Riuniti Ancona

  collaborator OTHER

• Careggi Hospital

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

• Monash University

  collaborator OTHER

• S.Eugenio Hospital

  collaborator OTHER

• Vittore Buzzi Children's Hospital

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

27 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-09

Primary Completion

2026-04-15

Completion

2026-04-15

Countries

• Italy

Study Locations