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

Last updated: November 2, 2023
Sponsor: Chiesi Farmaceutici S.p.A.
Overall Status: Terminated

Phase

3

Condition

Lung Injury

Respiratory Failure

Treatment

LISA combination product (Curosurf+catheter CHF6440)

Curosurf through conventional administration (endotracheal tube)

Clinical Study ID

NCT02772081
CCD-050000-01
  • Ages 30-24
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent obtained by parents/legal representative (according to localregulation) prior to or after birth
  2. Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathingand stabilized on non-invasive ventilation (NIV).
  3. Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15enrolled 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

Exclusion Criteria:

  1. Need for immediate endotracheal intubation for cardiopulmonary resuscitation orinsufficient 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 ofany other treatment (e.g. nitric oxide)
  4. Known genetic or chromosomal disorders, major congenital anomalies (congenital heartdiseases, 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 minutesafter 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 atundue risk
  10. Participation in another clinical trial of any medicinal product, placebo,experimental medical device, or biological substance conducted under the provisions ofa protocol on the same therapeutic target.

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: LISA combination product (Curosurf+catheter CHF6440)
Phase: 3
Study Start date:
May 18, 2021
Estimated Completion Date:
August 13, 2022

Study 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.

Connect with a study center

  • NICU Children's Hospital "V. Buzzi", ICP

    Milan, Lombardia 20153
    Italy

    Site Not Available

  • Chiesi Clinical Trial Site 84029

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84001

    Los Angeles, California 90033
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84002

    Los Angeles, California 90033
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84013

    Denver, Colorado 80204
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84014

    Farmington, Connecticut 06032
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84026

    New Britain, Connecticut 06052
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84003

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84021

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84023

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84028

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84005

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84008

    Lansing, Michigan 48912
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84004

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84012

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84024

    Manhasset, New York 11030
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84019

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84009

    Valhalla, New York 10595
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84027

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84010

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84025

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84017

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84020

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84007

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84016

    Houston, Texas 77030
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84011

    Lubbock, Texas 79410
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84006

    Plano, Texas 75075
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84022

    Temple, Texas 76502
    United States

    Site Not Available

  • Chiesi Clinical Trial Site 84015

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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