Comparison of INRECSURE and LISA in Preterm Neonates With RDS

NCT05711966 | Recruiting

• 1 other identifier: 4933
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Keywords

Respiratory Distress Syndrome; Surfactant; INRECSURE; LISA

Outcome Measures

Primary Outcomes (1)

• A composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age

  A composite outcome of death or bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age is the primary outcome because BPD represents the most severe respiratory morbidity of preterm infants and death is a competing risk. The diagnosis of BPD will be ascertained by a standardized test. Infants remaining on mechanical ventilation or CPAP at 36 weeks postmenstrual age, or those with a supplemental oxygen concentration ≥0.30 to obtain SpO2 between 90% to 94% will receive a BPD diagnosis without additional testing. Infants with a supplemental oxygen concentration \< 0.30 to obtain SpO2 between 90% to 94% or those receiving high-flow nasal cannula therapy will undergo a timed stepwise reduction to room air without any flow. Those in whom the reduction will not be tolerated will receive a BPD diagnosis.

  36 weeks' postmenstrual age or death

Secondary Outcomes (18)

• BPD at 36 weeks' s postmenstrual age

  36 weeks' s postmenstrual age

• Death at 36 weeks' s postmenstrual age or before discharge

  36 weeks' s postmenstrual age or hospital stay

• SpO2/FiO2 at 3 days, 7 days, and thereafter every 7 days until 36 weeks postmenstrual age

  36 weeks postmenstrual age

• Severe intraventricular hemorrhage (grade 3 or 4 based on the Papile criteria)

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks

• Occurrence of air leaks including pneumothorax or pulmonary interstitial emphysema before discharge

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks

Study Arms (2)

IN-REC-SUR-E

EXPERIMENTAL

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.

Device: Ventilator for High-frequency Oscillatory Ventilation (HFOV)

Less Invasive Surfactant Administration

ACTIVE COMPARATOR

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.

Device: Less invasive surfactant administration (LISA)

Interventions

Ventilator for High-frequency Oscillatory Ventilation (HFOV) DEVICE

This device will be used to perform an HFOV recruitment maneuver before surfactant administration

IN-REC-SUR-E

Less invasive surfactant administration (LISA) DEVICE

SurfCath™ tracheal instillation catheter, or a 4- 6 F end-hole catheter, according to local protocols will be used for surfactant administration

Less Invasive Surfactant Administration

Eligibility Criteria

• Age: 24 Weeks - 27 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe birth asphyxia or a 5-minute Apgar score less than 3
• Prior endotracheal intubation for resuscitation or insufficient respiratory drive
• Prolonged (\>21 days) premature rupture of membranes
• Presence of major congenital abnormalities
• Hydrops fetalis
• Inherited disorders of metabolism

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Dr. Behcet Uz Children's Hospital: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• University of Melbourne: collaborator
• University of California, San Diego: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Shengjing Hospital: collaborator
• Policlinico Casilino ASL RMB: collaborator
• The University of Western Australia: collaborator
• Catholic University of the Sacred Heart: collaborator
• Maggiore Hospital Carlo Alberto Pizzardi: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Ospedali Riuniti Ancona: collaborator
• Careggi Hospital: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Azienda Ospedaliera San Gerardo di Monza: collaborator
• Monash University: collaborator
• S.Eugenio Hospital: collaborator
• Vittore Buzzi Children's Hospital: collaborator

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (29)

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  PMID: 38956676 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Interventions

Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Giovanni Vento, MD

CONTACT

+39 0630153237; giovanni.vento@unicatt.it

Milena Tana, MD

CONTACT

+39 0630154357; milena.tana@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 3, 2023
• Study Start: January 9, 2023
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)