A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

NCT ID: NCT02772081

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-08-13

Brief Summary

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).

Detailed Description

This study was an open-label, multicentre, randomized, controlled study of spontaneously breathing neonates with RDS. Neonates were evaluated according to the selection criteria and then randomized to surfactant treatment via LISA or standard administration procedure. The enrolment was staggered: the gestational age was restricted to 27+0 weeks up to 28+6 weeks for the first 15 neonates. Provided no safety concerns were raised, the enrolment was planned to be extended to the whole population (i.e. 25+0 weeks up to 28+6 weeks). Enrolled neonates were evaluated in a main phase of the trial until discharge or 40 weeks post-menstrual age (PMA), whichever came first. Their clinical status and neurodevelopment was to be assessed at 24-month corrected age as a separate stand-alone visit.

The Sponsor decided to terminate the study early, due to uncertain sufficient availability of the CHF 6440 catheter.

Conditions

Respiratory Distress Syndrome (RDS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Curosurf LISA

Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS.

A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed.

After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.

Group Type: EXPERIMENTAL

LISA combination product (Curosurf+catheter CHF6440)

Intervention Type: COMBINATION_PRODUCT

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

Curosurf Endotracheal Tube

Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS.

A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed.

After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.

Group Type: ACTIVE_COMPARATOR

Curosurf through conventional administration (endotracheal tube)

Intervention Type: DRUG

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

Interventions

LISA combination product (Curosurf+catheter CHF6440)

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

Intervention Type: COMBINATION_PRODUCT

Curosurf through conventional administration (endotracheal tube)

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Minutes
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rangasamy Ramanathan, M.D.

Role: PRINCIPAL_INVESTIGATOR

LAC+USC Medical Center & Good Samaritan Hospital

Locations

Chiesi Clinical Trial Site 84029

Little Rock, Arkansas, United States

Chiesi Clinical Trial Site 84001

Los Angeles, California, United States

Chiesi Clinical Trial Site 84002

Los Angeles, California, United States

Chiesi Clinical Trial Site 84013

Denver, Colorado, United States

Chiesi Clinical Trial Site 84026

New Britain, Connecticut, United States

Chiesi Clinical Trial Site 84003

Evanston, Illinois, United States

Chiesi Clinical Trial Site 84021

Peoria, Illinois, United States

Chiesi Clinical Trial Site 84023

Lexington, Kentucky, United States

Chiesi Clinical Trial Site 84028

Springfield, Massachusetts, United States

Chiesi Clinical Trial Site 84005

Worcester, Massachusetts, United States

Chiesi Clinical Trial Site 84008

Lansing, Michigan, United States

Chiesi Clinical Trial Site 84004

St Louis, Missouri, United States

Chiesi Clinical Trial Site 84012

Camden, New Jersey, United States

Chiesi Clinical Trial Site 84024

Manhasset, New York, United States

Chiesi Clinical Trial Site 84019

New Hyde Park, New York, United States

Chiesi Clinical Trial Site 84009

Valhalla, New York, United States

Chiesi Clinical Trial Site 84027

Greenville, North Carolina, United States

Chiesi Clinical Trial Site 84010

Wilmington, North Carolina, United States

Chiesi Clinical Trial Site 84025

Cincinnati, Ohio, United States

Chiesi Clinical Trial Site 84017

Oklahoma City, Oklahoma, United States

Chiesi Clinical Trial Site 84020

Hershey, Pennsylvania, United States

Chiesi Clinical Trial Site 84007

Nashville, Tennessee, United States

Chiesi Clinical Trial Site 84011

Lubbock, Texas, United States

Chiesi Clinical Trial Site 84006

Plano, Texas, United States

Chiesi Clinical Trial Site 84022

Temple, Texas, United States

Chiesi Clinical Trial Site 84015

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001974-14/results

Study Record on EU Clinical Trials Register including results

Other Identifiers

CCD-050000-01

Identifier Type: -

Identifier Source: org_study_id