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

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VENTO GIOVANNI
• Treatments: Poractant alfa

Criteria

Inclusion Criteria:

• 1. Extremely low gestational age newborn infants (GA < 28 weeks) - gestational age matching between maternal dates and/or early antenatal ultrasound

• 2. Singleton or multiple birth

• 3. Postnatal age between 7 and 10 days

• 4. Invasive mechanical ventilation still needed

• 5. Fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours

• 6. Stable cardiovascular condition

• 7. Informed consent form signed by parents or legal guardian

Exclusion Criteria:

• 1. Major congenital malformation (i.e., infants with genetic, metabolic or endocrine disorder diagnosed before enrolment)

• 2. High index of suspicion of infection before enrolment

• 3. Neurological conditions that might contraindicate extubation

• 4. Inotropic agents needed

• 5. Pneumothorax

• 6. Hemodynamically significant ductus arteriosus

• 7. Surgical intervention within the past 72 hours

• 8. Partecipation in another interventional clinical study that may interfere with the results of this trial

• 9. Known hypersensitivity to the drug or to one of the excipients