Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study

Phase 4CompletedNCT00501982

Chiesi Farmaceutici S.p.A.208 enrolled

Overview

The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS: 1. Early stabilization on nCPAP 2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP. The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

208

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Eligibility

Sex: ALLMin age: 25 WeeksMax age: 28 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Preterm neonates with a gestational age (GA) of 25+0 - 28+6 completed weeks. * Inborn neonates. * In case of twins, both neonates will be included in the same treatment arm. * Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery. Exclusion Criteria: * Evidence of severe birth asphyxia, that is an APGAR score below 3 at 5 minutes of age. * Need for endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive. * Known genetic or chromosomal disorders. * Delivered to mothers with ruptured membranes of more than 3 weeks duration. * Potentially life-threatening conditions unrelated to immaturity. * Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Locations (5)

General Faculty Hospital

Prague, Czechia

Hopital De La Conception

Marseille, France

Ospedale Maggiore

Bologna, Italy

Maternidade Alfredo da Costa

Lisbon, Portugal

Hospital De Cruces

Bilbao, Spain

Outcomes

Primary Outcomes

Need for MV

Time frame: Within the first 5 days of life

Secondary Outcomes

Incidence of BPD and other complications of prematurity. Lenght of hospitalization. Clinical status until discharge home

Time frame: entire study