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

• Sponsor: Chiesi Farmaceutici S.p.A. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT02772081
• Collaborator: (none)
• Enrollment: 150
• Locations: 26
• Arms: 2
• Anticipated Duration (Months): 52.4
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.1

Study Details

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).

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.

Study Design

• Study Type: Interventional
• Anticipated 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.
• Actual Study Start Date: May 18, 2021
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

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

Outcome Measures

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 [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 [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 [At first surfactant administration]

4. Main Safety Outcome: Incidence of death at 36 weeks PMA [36 weeks PMA]

5. Main Safety Outcome: Incidence of bronchopulmonary dysplasia at 36 weeks PMA [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 [Discharge or 40 weeks PMA (whichever comes first)]

Secondary Outcome Measures

1. Main Efficacy Outcome: Percentage of neonates needing invasive mechanical ventilation [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 [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 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 [First 72 hours of life]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Minutes to 24 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiesi Clinical Trial Site 84029	Little Rock	Arkansas	United States	72205
2	Chiesi Clinical Trial Site 84001	Los Angeles	California	United States	90033
3	Chiesi Clinical Trial Site 84002	Los Angeles	California	United States	90033
4	Chiesi Clinical Trial Site 84013	Denver	Colorado	United States	80204
5	Chiesi Clinical Trial Site 84026	New Britain	Connecticut	United States	06052
6	Chiesi Clinical Trial Site 84003	Evanston	Illinois	United States	60201
7	Chiesi Clinical Trial Site 84021	Peoria	Illinois	United States	61637
8	Chiesi Clinical Trial Site 84023	Lexington	Kentucky	United States	40506
9	Chiesi Clinical Trial Site 84028	Springfield	Massachusetts	United States	01199
10	Chiesi Clinical Trial Site 84005	Worcester	Massachusetts	United States	01605
11	Chiesi Clinical Trial Site 84008	Lansing	Michigan	United States	48912
12	Chiesi Clinical Trial Site 84004	Saint Louis	Missouri	United States	63104
13	Chiesi Clinical Trial Site 84012	Camden	New Jersey	United States	08103
14	Chiesi Clinical Trial Site 84024	Manhasset	New York	United States	11030
15	Chiesi Clinical Trial Site 84019	New Hyde Park	New York	United States	11040
16	Chiesi Clinical Trial Site 84009	Valhalla	New York	United States	10595
17	Chiesi Clinical Trial Site 84027	Greenville	North Carolina	United States	27858
18	Chiesi Clinical Trial Site 84010	Wilmington	North Carolina	United States	28401
19	Chiesi Clinical Trial Site 84025	Cincinnati	Ohio	United States	45229
20	Chiesi Clinical Trial Site 84017	Oklahoma City	Oklahoma	United States	73104
21	Chiesi Clinical Trial Site 84020	Hershey	Pennsylvania	United States	17033
22	Chiesi Clinical Trial Site 84007	Nashville	Tennessee	United States	37212
23	Chiesi Clinical Trial Site 84011	Lubbock	Texas	United States	79410
24	Chiesi Clinical Trial Site 84006	Plano	Texas	United States	75075
25	Chiesi Clinical Trial Site 84022	Temple	Texas	United States	76502
26	Chiesi Clinical Trial Site 84015	Charlottesville	Virginia	United States	22908

Sponsors and Collaborators

• Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Rangasamy Ramanathan, M.D., LAC+USC Medical Center & Good Samaritan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chiesi Farmaceutici S.p.A.
• ClinicalTrials.gov Identifier: NCT02772081
• Other Study ID Numbers: CCD-050000-01
• First Posted: May 13, 2016
• Last Update Posted: May 9, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome; Poractant alfa

Study Results

No Results Posted as of May 9, 2022