2 part study in spontaneously breathing preterm neonates with mild to moderate respiratory distress syndrome

Phase 1

Conditions: Mild to moderate respiratory distress syndrome
MedDRA version: 20.0Level: LLTClassification code 10038690Term: Respiratory distress syndrome (neonatal)System Organ Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-004547-36-GB

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 288

Inclusion Criteria

Neonates must meet all of the following inclusion criteria to be eligible
for enrolment into the study:
1. Written informed consent obtained by parents/legal representative
(according to local regulation) prior to or after birth.
2. Inborn neonates from 28+0 to 32+6 weeks of GA, spontaneously
breathing and stabilized on nCPAP within 1 hour from birth.
3. Clinical course consistent with RDS.
4. Receiving CPAP pressure 5-8 cm H2O and FiO2 between 0.25 and 0.40
to maintain SpO2 between 88% and 95% for at least 30 minutes.
Randomisation should occur between 60 minutes and 12 hours after
birth.
Are the trial subjects under 18? yes
Number of subjects for this age range: 288
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

The presence of any of the following will exclude a neonate from study enrolment:
1. Early need for endotracheal intubation for cardiopulmonary resuscitation in delivery room or within 1 hour from birth because of severe RDS [one of the following conditions: rapid (i.e. within 1 h) and persistent (> 30 min) escalation of FiO2 > 0.40 for target SpO2 88-95% in 1 hour, recurrent episodes of apnoea (>2 episodes) requiring positive pressure ventilation (PPV)].
2. Respiratory distress not secondary to surfactant deficiency (see APPENDIX 3).
3. Use of surfactant prior to study entry and need for endotracheal administration of any other treatment.
4. Evidence of severe birth asphyxia (e.g. Apgar score = 5 at 10 minutes after birth, or continued need for resuscitation at 10 minutes after birth, altered neurological state or neonatal encephalopathy).
5. Major congenital anomalies.
6. Mothers with prolonged rupture of the membranes (> 21 days duration) which could cause complications (in particular severe pulmonary hypoplasia due to oligohydramnios).
7. Presence of air leaks identified and known prior to study entry.
8. Presence of IVH = III identified and known prior to study entry.
9. Hypotension or evidence of hemodynamic instability requiring pharmacological intervention for hemodynamic support.
10. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk.
11. Participation in another clinical trial of any placebo, experimental medical device or biological substance conducted under the provisions of a protocol on the same therapeutic target; the participation in studies involving diagnostic devices or studies with treatments for different conditions than lung and respiratory function impairments s may be permitted following an agreement with the sponsor. Non interventional observational studies are allowed.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Part I: Objective<br>To assess the safety and tolerability of three single ascending doses of nebulized Curosurf®.<br><br> Part II Objective<br>To compare the efficacy of nebulized Curosurf®, administered at low dose (dose 1) or high dose (dose 2), during nCPAP, versus nCPAP alone in terms of incidence of respiratory failure in the first 72 hours of life in spontaneously breathing preterm neonates with mild to moderate RDS.<br>;Secondary Objective: Not applicable;Primary end point(s): Safety parameters (AEs and ADRs) and Respiratory failure (needing additional poractant ET administration or mecanical ventilation)<br>;Timepoint(s) of evaluation of this end point: during 72 h of life and up to diagnosis of BPD

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Blood gas analysis and measure of SpO2<br>;Timepoint(s) of evaluation of this end point: During 72 h of life and up to diagnosis of BPD

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