A study in preterm neonates with Respiratory Distress Syndrome (RDS) to compare CUROSURF® administration through LISA and conventional administration (LISPAP).

Phase 1

• Conditions: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-001974-14-Outside-EU/EEA
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-11
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all the following inclusion criteria to be eligible for enrollment into the study:
1. Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth;
2. Preterm neonates of either sex aged =30 minutes and <24 hours, spontaneously breathing and stabilized on NIV;
3. Gestational age of 25+0 weeks up to 28+6 completed weeks; enrollment will be restricted to subjects aged 27+0 weeks up to 28+6 GA weeks until safety evaluation of first 15 subjects is completed;
4. Clinical course consistent with RDS;
5. FiO2 =0.30 to maintain preductal SpO2 in the target range of 88–95%.
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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

The presence of any of the following will exclude a subject from the study enrollment:
1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive;
2. Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry;
3. Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide);
4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele, etc);
5. Mothers with prolonged premature rupture of the membranes (>21 days duration) which could cause complications (in particular severe pulmonary hypoplasia due to oligohydramnios);
6. Presence of air leaks if identified and known prior to study entry;
7. Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state or neonatal encephalopathy);
8. Neonatal seizures prior to study entry;
9. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk;
10. Participation in another clinical trial of any medicinal product, 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 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