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Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants.

NCT04073173 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-09-03

No results posted yet for this study

Summary

This study will compare stress, changes in oxygenation and oxidative damage in preterm infants with respiratory distress syndrome (RDS) randomized to receive or not remifentanil as an analgesic drug during the administration of porcine surfactant (poractant alfa, Curosurf®) through the traditional (INSURE) or the less invasive (LISA) method.

Conditions

  • Respiratory Distress Syndrome in Premature Infants

Interventions

PROCEDURE

INSURE

Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.

PROCEDURE

LISA

Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.

DRUG

Analgesic, Opioid

Remifentanil (0.5-2 micrograms/kg/dose)

Sponsors & Collaborators

  • Fondazione Cassa di Risparmio di Verona Vicenza Belluno e Ancona

    collaborator UNKNOWN

  • Istituto di Ricerca Pediatrica Città della Speranza

    collaborator UNKNOWN

  • Virgilio Paolo Carnielli

    lead OTHER

Principal Investigators

  • Virgilio Carnielli, MD, PHD · Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

  • Clementina Rondina, MD · Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
168 Days
Max Age
223 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-10-31
Completion
2022-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073173 on ClinicalTrials.gov