Comparison of IN-REC-SUR-E and LISA in Preterm Neonates With Respiratory Distress Syndrome: a Randomized Controlled Trial (IN-REC-LISA Trial)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary hypothesis of this study is that surfactant administration by INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E), via a high frequency oscillatory ventilation recruitment maneuver increases survival without BPD at 36 weeks' gestational age in spontaneously breathing infants born at 24+0-27+6 weeks' gestation affected by Respiratory Distress Syndrome (RDS) and failing nasal CPAP or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 hours of life compared to less invasive surfactant administration (LISA).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 6 months
Healthy Volunteers: f
View:

⁃ Infants satisfying the following inclusion criteria will be eligible to participate:

• Born at 24+0-27+6 in a tertiary neonatal intensive care unit participating in the trial (and)

• Breathing independently and sufficiently with only nasal CPAP or NIPPV for respiratory support (and)

• Written parental consent has been obtained (and)

• Failing nasal CPAP or NIPPV during the first 24 hours of life

Locations
Other Locations
Italy
Fondazione Policlinico Agostino Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Giovanni Vento, MD
giovanni.vento@unicatt.it
+39 0630153237
Backup
Milena Tana, MD
milena.tana@policlinicogemelli.it
+39 0630154357
Time Frame
Start Date: 2023-01-09
Estimated Completion Date: 2026-04-15
Participants
Target number of participants: 381
Treatments
Experimental: IN-REC-SUR-E
INRECSURE infants will receive preintubation medications and HFOV starting at MAP 8 cmH2O; frequency 15 Hz, with volume-guarantee (1.5-1.7 mL/kg). The I:E will be 1:1. An oxygenation guid-ed lung recruitment procedure will be performed using stepwise increments then decrements in MAP. The starting MAP will be increased stepwise as long as SpO2 improves reducing the FiO2 keeping SpO2 within the target range (90-94 %) until the oxygenation no longer improves or the FiO2 is equal to or less than 0.25 (opening MAP). Next, the MAP will be reduced stepwise until the SpO2 deterio-rates (closing MAP). After a second recruitment maneuver at the opening pressure, the optimal MAP will be set 2 cmH2O above the closing MAP. Then 200 mg/kg of poractant alfa (Chiesi Farmaceutici S.p.A., Parma, Italy) via a closed administration system will administrate. Infants with sufficient res-piratory drive will be extubated within 30 minutes after surfactant administration starting nCPAP (7-9 cm H2O) or NIPPV.
Active_comparator: Less Invasive Surfactant Administration
By contrast, infants allocated to the LISA group will receive 200 mg/kg of poractant alfa (Chiesi Farmaceutici S.p.A., Parma, Italy) according to the following protocol: during nasal CPAP with a pressure of 7-8 cm H2O, surfactant will be administered over 0.5-3 min using the SurfCath™ tracheal instillation catheter (VYGON S.A. - Ecouen, France), or a 4- 6 F end-hole catheter, according to local protocols. After the same pre-procedural medications, the catheters will be positioned during laryngoscopy with or without Magill forceps. The catheter will be connected to a syringe pre-filled with the surfactant, and the surfactant is instilled slowly. The infant's mouth will be closed. In cases of apnoea or bradycardia, positive pressure ventilation will be performed until recovery. After surfactant administration, CPAP (7-9 cm H2O) therapy (16) or NIPPV will be continued.
Related Therapeutic Areas
Sponsors
Collaborators: Monash University, Catholic University of the Sacred Heart, Vittore Buzzi Children's Hospital, University of California, San Diego, The University of Western Australia, S.Eugenio Hospital, Maggiore Hospital Carlo Alberto Pizzardi, University Hospital Schleswig-Holstein, Policlinico Casilino ASL RMB, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Universitair Ziekenhuis Brussel, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Azienda Ospedaliera San Gerardo di Monza, University of Melbourne, Shengjing Hospital, Dr. Behcet Uz Children's Hospital, Careggi Hospital, Ospedali Riuniti Ancona
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov