Clinical trial

An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.

ID

Name

CCD-050000-01

Description

This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates who have clinical signs of respiratory distress syndrome (RDS).

Trial arms

Trial start

2021-05-18

Estimated PCD

2022-08-13

Trial end

2022-08-13

Status

Terminated

Phase

Early phase I

Treatment

LISA combination product (Curosurf+catheter CHF6440)

Curosurf administration through brief insertion of a thin catheter into the trachea

Arms:

Curosurf LISA

Curosurf through conventional administration (endotracheal tube)

Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Arms:

Curosurf Endotracheal Tube

Size

33

Primary endpoint

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment

First 72 hours of life.

Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube

At first surfactant administration, up to Day 1.

Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion)

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Safety: Study Treatment Administration: Duration of Surfactant Administration

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Safety: Study Treatment Administration: Duration of the Whole Procedure

At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Eligibility criteria

Inclusion Criteria: 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 non-invasive ventilation (NIV). 3. Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks. 4. Clinical course consistent with RDS. 5. Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%. Exclusion Criteria: 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 rupture of the membranes (\> 21 days duration) 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}

Updated at

2023-11-07

1 organization

2 products

1 indication

Product

Indication

Respiratory Distress Syndrome

Product

Organization

Chiesi Farmaceutici