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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772081
Recruitment Status : Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

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).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Combination Product: LISA combination product (Curosurf+catheter CHF6440) Drug: Curosurf through conventional administration (endotracheal tube) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : March 19, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : May 30, 2025


Arm Intervention/treatment
Experimental: 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.

Combination Product: LISA combination product (Curosurf+catheter CHF6440)
Curosurf administration through brief insertion of a thin catheter into the trachea

Active Comparator: 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.

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




Primary Outcome Measures :
  1. 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 ]
  2. 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) ]
  3. 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 ]
  4. Main Safety Outcome: Incidence of death at 36 weeks PMA [ Time Frame: 36 weeks PMA ]
  5. Main Safety Outcome: Incidence of bronchopulmonary dysplasia at 36 weeks PMA [ Time Frame: 36 weeks PMA ]
  6. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Main Efficacy Outcome: Percentage of neonates requiring at least one additional surfactant dose [ Time Frame: First 72 hours of life ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772081


Contacts
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Contact: Chiesi Clinical Trial Info +39.05212791 clinicaltrials_info@chiesi.com

Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Rangasamy Ramanathan, M.D. LAC+USC Medical Center & Good Samaritan Hospital
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT02772081    
Other Study ID Numbers: CCD-050000-01
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Poractant alfa
Pulmonary Surfactants
Respiratory System Agents