Efficacy of a New Technique -"IN-REC-SUR-E"- in Preterm Neonates With RDS

Summary

The primary hypothesis of this study is reduction in need of mechanical ventilation in the first 72 hours of life (excluding the transient tracheal intubation performed for surfactant administration and the mechanical ventilation for lung recruitment) in spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 hours of life who received an HFOV recruitment maneuver (IN-REC-SUR-E) compared to no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation.

Conditions

• Respiratory Distress Syndrome
• Hyaline Membrane Disease

Interventions

DRUG

Poractant alfa, 200 mg/kg

Endotracheal Surfactant administration

DEVICE

Ventilator for High-frequency Oscillatory Ventilation (HFOV)

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

DEVICE

Nasal Continuous Positive Airway Pressure (nCPAP)

After surfactant administration, the babies will be extubated within 30 minutes and will receive nCPAP (6-8 cm H2O)

Sponsors & Collaborators

• Ospedali Riuniti Ancona

  collaborator OTHER

• Careggi Hospital

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Centre for Neonatal Research and Education, Crawley, West Australia

  collaborator UNKNOWN

• Monash University

  collaborator OTHER

• Azienda Ospedaliera San Gerardo di Monza

  collaborator OTHER

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

  collaborator OTHER

• Catholic University of the Sacred Heart

  lead OTHER

Principal Investigators

• Giovanni Vento, MD · Catholic University of the Sacred Heart

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

27 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-11-30

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• Italy

Study Locations