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Surfactant
LISA combination product (Curosurf+catheter CHF6440) for Respiratory Distress Syndrome (LISPAP Trial)
Phase 3
Waitlist Available
Led By Rangasamy Ramanathan, M.D.
Research Sponsored by Chiesi Farmaceutici S.p.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
LISPAP Trial Summary
This study is evaluating whether a surfactant which is delivered through a thin catheter may help premature babies breathe easier.
Eligible Conditions
- Respiratory Distress Syndrome
LISPAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Study Treatment Administration: Duration of Surfactant Administration
Safety: Study Treatment Administration: Duration of the Whole Procedure
Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion
+4 moreSecondary outcome measures
Efficacy: Blood Analysis Parameter -- Base Excess
Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-)
Efficacy: Blood Analysis Parameter -- Lactate
+13 moreSide effects data
From 2016 Phase 3 trial • 88 Patients • NCT017094097%
air leak
5%
pulmonary hemorrhage
2%
pulmonary interstitial emphysema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Curosurf (Group 1)
BLES (Group 2)
LISPAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Curosurf LISAExperimental Treatment1 Intervention
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.
Group II: Curosurf Endotracheal TubeActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Chiesi Farmaceutici S.p.A.Lead Sponsor
198 Previous Clinical Trials
311,881 Total Patients Enrolled
8 Trials studying Respiratory Distress Syndrome
1,707 Patients Enrolled for Respiratory Distress Syndrome
Rangasamy Ramanathan, M.D.Principal InvestigatorLAC+USC Medical Center & Good Samaritan Hospital
Frequently Asked Questions
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