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

NACompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Respiratory Distress SyndromeHyaline 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)

Trial Locations (33)

36100

Ospedale San Bortolo, Vicenza

73100

Ospedale Vito Fazzi, Lecce

81030

Pineta Grande, Caserta

Unknown

Ospedale Salesi, Ancona

Ospedale Di Venere, Bari

Ospedale Maggiore, Bologna

Fondazione Poliambulanza, Brescia

Ospedale di Bolzano, Bolzano

S. Sebastiano e S. Anna, Caserta

Azienda Ospedaliera di Cosenza, Cosenza

AOU Policlinico Vittorio Emanuele- Presidio Ospedaliero Gaspare Rodolico, Catania

Ospedale Nuovo Garibaldi-Nesima, Catania

Ospedale Barone Romeo, Patti

SS Antonio e Biagio e Cesare Arrigo, Alessandria

Azienda Ospedaliera Universitaria Ferrara, Ferrara

Careggi, Florence

Ospedali Riuniti, Foggia

Ospedale San Salvatore, L’Aquila

Carlo Poma, Mantova

Università degli studi di Messina A.O.U. Policlinico G. Martino, Messina

Mangiagalli, Milan

Ospedale Niguarda, Milan

A.O.U. di Modena Policlinico, Modena

S. Gerardo, Monza

Ospedale Maggiore, Novara

Arnas Civico di Palermo, Palermo

A.O. Bianchi-Melacrino-Morelli, Reggio Calabria

Arcispedale Santa Maria Nuova, Reggio Emilia

Fatebenefratelli-Isola Tiberina, Roma

A.O. Treviso Ospedale Cà Foncello, Treviso

Belcolle, Viterbo

00100

Ospedale san Pietro Fatebenefratelli, Rome

00168

Policlinico Gemelli-Università Cattolica S. Cuore, Rome

All Listed Sponsors
collaborator

Ospedali Riuniti Ancona

OTHER

collaborator

Careggi Hospital

OTHER

collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

collaborator

Centre for Neonatal Research and Education, Crawley, West Australia

UNKNOWN

collaborator

Monash University

OTHER

collaborator

Azienda Ospedaliera San Gerardo di Monza

OTHER

collaborator

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

OTHER

lead

Catholic University of the Sacred Heart

OTHER

NCT02482766 - "Efficacy of a New Technique -IN-REC-SUR-E- in Preterm Neonates With RDS" | Biotech Hunter | Biotech Hunter