Comparison of two respiratory severity thresholds as indications for the administration of exogenous surfactant in preterm infants with respiratory disease.

Phase 1

• Conditions: eonatal respiratory distress syndrome (RDS); MedDRA version: 21.1Level: LLTClassification code 10038690Term: Respiratory distress syndrome (neonatal)System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002923-13-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

- gestational age between 24 and 32 weeks postmenstrual age;
- diagnosis of neonatal respiratory distress (RDS);
- need of invasive/non-invasive ventilatory support;
- written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- congenital malformations;
- genetic disorders;
- perinatal asphyxia;
- presence or concomitance of other diseases compatible with RDS.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the superior effectiveness of the respiratory severity level CURO25 (FiO2>25%) compared to the respiratory severity level CURO35 (FiO2>35% - actual clinical practice in the study center) as indication for the exogenous surfactant administration in preterm infants with respiratory distress syndrome (RDS).;Secondary Objective: To evaluate the effects of two respiratory severity levels (CURO25 vs CURO35) as indications for the exogenous surfactant administration in preterm infants with respiratory distress syndrome (RDS) in terms of the incidence of neonatal complications, duration of in-hospital therapy and short-medium respiratory outcomes.;Primary end point(s): Respiratory function defined as oxygen saturation/FiO2 ratio (SFR).;Timepoint(s) of evaluation of this end point: At day 3 of life.