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

NCT02772081 | Terminated Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: CCD-050000-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 26

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).

Conditions

Respiratory Distress Syndrome (RDS)

Keywords

Less Invasive Surfactant administration; LISPAP; Neonates; Newborns; Respiratory Distress Syndrome (RDS); CUROSURF®

Outcome Measures

Primary Outcomes (7)

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

  Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment. All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered.

  First 72 hours of life.

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

  Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group.

  At first surfactant administration, up to Day 1.

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

  Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group.

  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

  Number of attempts required to achieve first successful insertion is presented by treatment group.

  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)

  Number of device misallocation for LISA administration group (esophageal insertion). Data was not collected from participants in the "Curosurf Endotracheal Tube" -- the control arm of the study, because it is not applicable.

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

• Safety: Study Treatment Administration: Duration of Surfactant Administration

  Duration of surfactant administration is presented by treatment group.

  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

  Duration of the whole procedure (starting from the insertion of laryngoscope up to the removal of the catheter/ETT), is presented by treatment group.

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

Secondary Outcomes (16)

• Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV)

  First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).

• Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant

  First 72 hours of life.

• Efficacy: Neonates Needing Additional Surfactant Doses

  First 72 hours of life.

• Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio

  Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.

• Efficacy: Fraction of Inspired Oxygen (FiO2)

  Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.

Study Arms (2)

Curosurf LISA

EXPERIMENTAL

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.

Combination Product: LISA combination product (Curosurf+catheter CHF6440)

Curosurf Endotracheal Tube

ACTIVE COMPARATOR

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.

Drug: Curosurf through conventional administration (endotracheal tube)

Interventions

LISA combination product (Curosurf+catheter CHF6440) COMBINATION_PRODUCT

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

Curosurf LISA

Curosurf through conventional administration (endotracheal tube) DRUG

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

Curosurf Endotracheal Tube

Eligibility Criteria

• Age: 30 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
• Preterm neonates of either sex aged ≥30 minutes and \<24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
• 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.
• Clinical course consistent with RDS.
• Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.

You may not qualify if:

• Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
• Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
• Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
• Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)
• Mothers with prolonged rupture of the membranes (\> 21 days duration)
• Presence of air leaks if identified and known prior to study entry
• Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)
• Neonatal seizures prior to study entry
• Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (26)

Chiesi Clinical Trial Site 84029

Little Rock, Arkansas, 72205, United States

Location

Chiesi Clinical Trial Site 84001

Los Angeles, California, 90033, United States

Location

Chiesi Clinical Trial Site 84002

Los Angeles, California, 90033, United States

Location

Chiesi Clinical Trial Site 84013

Denver, Colorado, 80204, United States

Location

Chiesi Clinical Trial Site 84026

New Britain, Connecticut, 06052, United States

Location

Chiesi Clinical Trial Site 84003

Evanston, Illinois, 60201, United States

Location

Chiesi Clinical Trial Site 84021

Peoria, Illinois, 61637, United States

Location

Chiesi Clinical Trial Site 84023

Lexington, Kentucky, 40506, United States

Location

Chiesi Clinical Trial Site 84028

Springfield, Massachusetts, 01199, United States

Location

Chiesi Clinical Trial Site 84005

Worcester, Massachusetts, 01605, United States

Location

Chiesi Clinical Trial Site 84008

Lansing, Michigan, 48912, United States

Location

Chiesi Clinical Trial Site 84004

St Louis, Missouri, 63104, United States

Location

Chiesi Clinical Trial Site 84012

Camden, New Jersey, 08103, United States

Location

Chiesi Clinical Trial Site 84024

Manhasset, New York, 11030, United States

Location

Chiesi Clinical Trial Site 84019

New Hyde Park, New York, 11040, United States

Location

Chiesi Clinical Trial Site 84009

Valhalla, New York, 10595, United States

Location

Chiesi Clinical Trial Site 84027

Greenville, North Carolina, 27858, United States

Location

Chiesi Clinical Trial Site 84010

Wilmington, North Carolina, 28401, United States

Location

Chiesi Clinical Trial Site 84025

Cincinnati, Ohio, 45229, United States

Location

Chiesi Clinical Trial Site 84017

Oklahoma City, Oklahoma, 73104, United States

Location

Chiesi Clinical Trial Site 84020

Hershey, Pennsylvania, 17033, United States

Location

Chiesi Clinical Trial Site 84007

Nashville, Tennessee, 37212, United States

Location

Chiesi Clinical Trial Site 84011

Lubbock, Texas, 79410, United States

Location

Chiesi Clinical Trial Site 84006

Plano, Texas, 75075, United States

Location

Chiesi Clinical Trial Site 84022

Temple, Texas, 76502, United States

Location

Chiesi Clinical Trial Site 84015

Charlottesville, Virginia, 22908, United States

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Limitations and Caveats

The Sponsor issued an early notification of an immediate enrolment hold to participating study sites (01 June 2022) and an official notification (05 July 2022) after identifying uncertain availability of the CHF 6440 catheter. Because the availability of CHF 6440 catheter to all participating study sites could not be assured, the Sponsor decided to terminate the study early.

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Study Officials

• Rangasamy Ramanathan, M.D.

  LAC+USC Medical Center & Good Samaritan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 13, 2016
• Study Start: May 18, 2021
• Primary Completion: August 13, 2022
• Study Completion: August 13, 2022
• Last Updated: November 7, 2023
• Results First Posted: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)