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

No Placebo-Only Group

Pivotal Trial

Summary

This trial tested a gentler way to give a special medicine to help premature babies with breathing problems. The medicine helps their lungs stay open, making it easier for them to breathe.

Eligible Conditions

Respiratory Distress Syndrome

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

Efficacy: Blood Analysis Parameter -- Base Excess

Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-)

Efficacy: Blood Analysis Parameter -- Lactate

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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