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Monoclonal Antibodies

Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial (LateRecSurf Trial)

Phase 2
Recruiting
Led By Giovanni Vento, Professor
Research Sponsored by VENTO GIOVANNI
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 through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This is an unblinded monocentric pilot superiority trial that will be conducted in a IIIlevel NICU at Fondazione Policlinico Agostino Gemelli - IRCCS. The aim of the study is to test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation. Extremely low gestational age newborn infants (GA \< 28 weeks) still requiring invasive mechanical ventilation at a postnatal age between 7 and 10 days will be eligible for the study. The study population will be randomly assigned to experimental protocol or to standard care. Treatment group will receive up to 4 doses (100 mg Kg) of Poractant alfa every 12 hours; each dose will be preceded by a recruitment manoeuvre in HFOV. Primary endpoint will be the first successful extubation defined as extubation not followed by a reintubation for at least 7 days. Several secondary endpoints will be collected, including respiratory status at one year of age.

Eligible Conditions
  • Bronchopulmonary Dysplasia
  • Chronic Lung Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year of life
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year of life for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
First successful extubation
Secondary study objectives
Length of hospital stay
Length of invasive mechanical ventilation
Length of oxygen-therapy
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LRS GroupExperimental Treatment1 Intervention
This arm will receive up to 4 doses (100 mg Kg) of Poractant alfa (Curosurf, Chiesi) every 12 hours; each dose preceded by a recruitment manoeuvre in HFOV. Optimal recruitment is defined as adequate oxygenation using a fraction of inspired oxygen (FiO2) of 0.30 or less. The continuous distending pressure (CDP) will be increased stepwise (1 cmH2O every 2-3 min) as long as pulse oximetry (SpO2) improves. The FiO2 will be reduced stepwise, keeping SpO2 within the target range (87-94 %). The recruitment procedure will be stopped if oxygenation no longer improves or if the FiO2 is equal to or less than 0.30. The corresponding CDP will be called the opening pressure (CDPO). Next, the CDP will be reduced stepwise (1-2 cmH2O every 2-3 min) until the SpO2 deteriorates (by at least 2-3 points). The corresponding CDP will be called the closing pressure (CDPC). After a second recruitment maneuver at CDPO for 5 min, the optimal CDP (CDPOPT) will be set 2 cmH2O above the CDPC for at least 3 min.
Group II: Standard GroupActive Control1 Intervention
This arm will be managed following the ward standard ventilatory protocol which does not contemplate neither surfactant administration nor recruitment manoeuvre.

Find a Location

Who is running the clinical trial?

VENTO GIOVANNILead Sponsor
Giovanni Vento, ProfessorPrincipal InvestigatorFondazione Policlinico Agostino Gemelli IRCCS
~5 spots leftby Dec 2025