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A Study in Preterm Neonates With RDS to Compare CUROSURF® Administration Through LISA and Conventional Administration (LISPAP)

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LISA combination product (Curosurf+catheter CHF6440)
Curosurf through conventional administration (endotracheal tube)
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn

Eligibility Criteria

30 Minutes - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Chiesi Clinical Trial Site 84029
  • Chiesi Clinical Trial Site 84001
  • Chiesi Clinical Trial Site 84002
  • Chiesi Clinical Trial Site 84013
  • Chiesi Clinical Trial Site 84026
  • Chiesi Clinical Trial Site 84003
  • Chiesi Clinical Trial Site 84021
  • Chiesi Clinical Trial Site 84023
  • Chiesi Clinical Trial Site 84028
  • Chiesi Clinical Trial Site 84005
  • Chiesi Clinical Trial Site 84008
  • Chiesi Clinical Trial Site 84004
  • Chiesi Clinical Trial Site 84012
  • Chiesi Clinical Trial Site 84024
  • Chiesi Clinical Trial Site 84019
  • Chiesi Clinical Trial Site 84009
  • Chiesi Clinical Trial Site 84027
  • Chiesi Clinical Trial Site 84010
  • Chiesi Clinical Trial Site 84025
  • Chiesi Clinical Trial Site 84017
  • Chiesi Clinical Trial Site 84020
  • Chiesi Clinical Trial Site 84007
  • Chiesi Clinical Trial Site 84011
  • Chiesi Clinical Trial Site 84006
  • Chiesi Clinical Trial Site 84022
  • Chiesi Clinical Trial Site 84015

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Curosurf LISA

Curosurf Endotracheal Tube

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Main Safety Outcome: Number and percentage of neonates with adverse events started during the procedure for surfactant administration and judged related to the procedure
Main Safety Outcome: Incidence of AEs (including neonatal complications of prematurity), incidence of adverse drugs reactions, incidence of serious adverse events, incidence of AEs leading to death
Main Safety Outcome: Number of first failed attempts to insert the catheter/endotracheal tube and percentage of neonates with first failed attempt
Main Safety Outcome: Incidence of death at 36 weeks PMA
Main Safety Outcome: Incidence of bronchopulmonary dysplasia at 36 weeks PMA
Main Safety Outcome: Health status at discharge or 40 weeks PMA (whichever comes first): feeding status, hearing status, growth parameters, need for respiratory support or respiratory medication

Secondary Outcome Measures

Main Efficacy Outcome: Percentage of neonates needing invasive mechanical ventilation
Main Efficacy Outcome: Median duration of invasive mechanical ventilation
Main Efficacy Outcome: Preductal Oxygen Saturation (SpO2), Fraction of Inspired Oxygen (FiO2) and SpO2/FiO2 ratio
Main Efficacy Outcome: Percentage of neonates requiring at least one additional surfactant dose

Full Information

First Posted
May 6, 2016
Last Updated
September 20, 2022
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02772081
Brief Title
A Study in Preterm Neonates With RDS to Compare CUROSURF® Administration Through LISA and Conventional Administration
Acronym
LISPAP
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
August 13, 2022 (Actual)
Study Completion Date
August 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curosurf LISA
Arm Type
Experimental
Arm Description
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.
Arm Title
Curosurf Endotracheal Tube
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
LISA combination product (Curosurf+catheter CHF6440)
Intervention Description
Curosurf administration through brief insertion of a thin catheter into the trachea
Intervention Type
Drug
Intervention Name(s)
Curosurf through conventional administration (endotracheal tube)
Intervention Description
Curosurf through conventional administration (endotracheal tube), followed by rapid extubation
Primary Outcome Measure Information:
Title
Main Safety Outcome: Number and percentage of neonates with adverse events started during the procedure for surfactant administration and judged related to the procedure
Time Frame
From the application of the laryngoscope up to the removal of the CHF 6440 catheter or the endotracheal tube
Title
Main Safety Outcome: Incidence of AEs (including neonatal complications of prematurity), incidence of adverse drugs reactions, incidence of serious adverse events, incidence of AEs leading to death
Time Frame
From the application of the laryngoscope up to the end of the main phase of the study (discharge or 40 weeks Post-Menstrual Age [PMA], whichever comes first)
Title
Main Safety Outcome: Number of first failed attempts to insert the catheter/endotracheal tube and percentage of neonates with first failed attempt
Time Frame
At first surfactant administration
Title
Main Safety Outcome: Incidence of death at 36 weeks PMA
Time Frame
36 weeks PMA
Title
Main Safety Outcome: Incidence of bronchopulmonary dysplasia at 36 weeks PMA
Time Frame
36 weeks PMA
Title
Main Safety Outcome: Health status at discharge or 40 weeks PMA (whichever comes first): feeding status, hearing status, growth parameters, need for respiratory support or respiratory medication
Time Frame
Discharge or 40 weeks PMA (whichever comes first)
Secondary Outcome Measure Information:
Title
Main Efficacy Outcome: Percentage of neonates needing invasive mechanical ventilation
Time Frame
First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA
Title
Main Efficacy Outcome: Median duration of invasive mechanical ventilation
Time Frame
First 72 hours of life, Up to 28 days PNA, Up to 36 weeks PMA
Title
Main Efficacy Outcome: Preductal Oxygen Saturation (SpO2), Fraction of Inspired Oxygen (FiO2) and SpO2/FiO2 ratio
Time Frame
Time 0 (study treatment administration), 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72 and 120 hours post treatment
Title
Main Efficacy Outcome: Percentage of neonates requiring at least one additional surfactant dose
Time Frame
First 72 hours of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 SpO2 between 88-95%. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rangasamy Ramanathan, M.D.
Organizational Affiliation
LAC+USC Medical Center & Good Samaritan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi Clinical Trial Site 84029
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Chiesi Clinical Trial Site 84001
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Chiesi Clinical Trial Site 84002
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Chiesi Clinical Trial Site 84013
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Chiesi Clinical Trial Site 84026
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Chiesi Clinical Trial Site 84003
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Chiesi Clinical Trial Site 84021
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Chiesi Clinical Trial Site 84023
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
Chiesi Clinical Trial Site 84028
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Chiesi Clinical Trial Site 84005
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Chiesi Clinical Trial Site 84008
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Chiesi Clinical Trial Site 84004
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Chiesi Clinical Trial Site 84012
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Chiesi Clinical Trial Site 84024
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Chiesi Clinical Trial Site 84019
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Chiesi Clinical Trial Site 84009
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Chiesi Clinical Trial Site 84027
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Chiesi Clinical Trial Site 84010
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Chiesi Clinical Trial Site 84025
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Chiesi Clinical Trial Site 84017
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Chiesi Clinical Trial Site 84020
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Chiesi Clinical Trial Site 84007
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Chiesi Clinical Trial Site 84011
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Chiesi Clinical Trial Site 84006
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Chiesi Clinical Trial Site 84022
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
Chiesi Clinical Trial Site 84015
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study in Preterm Neonates With RDS to Compare CUROSURF® Administration Through LISA and Conventional Administration

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