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

• Status: Completed
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catholic University of the Sacred Heart
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Azienda Ospedaliera San Gerardo di Monza; Centre for Neonatal Research and Education, Crawley, West Australia; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Monash University; Ospedale Careggi, Florence, Italy; Ospedali Riuniti Ancona
• Treatments: Poractant alfa; Pulmonary Surfactants

Criteria

Inclusion Criteria:

1. In-Born at 24+0-27+6 (and)

2. Spontaneously breathing at birth but requiring respiratory support (CPAP or O2) at 5' of life (and)

3. Parental consent has been obtained (and)

4. Failing nCPAP during the first 24 hours of life

Exclusion Criteria:

1. Severe birth asphyxia or a 5-minute Apgar score <3

2. Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to AAP guidelines16

3. Prolonged PROM > 3 weeks

4. Presence of major congenital malformations

5. Hydrops fetalis

6. Inherited disorders of metabolism