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

• Status: Not yet recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virgilio Paolo Carnielli
• Collaborators: Fondazione Cassa di Risparmio di Verona Vicenza Belluno e Ancona; Istituto di Ricerca Pediatrica Città della Speranza
• Treatments: Analgesics; Analgesics, Opioid; Pulmonary Surfactants; Remifentanil

Criteria

Inclusion Criteria:

• gestational age at birth between 168 and 223 days,

• respiratory distress syndrome (diagnosed on the basis of clinical and/or radiological grounds) with a fraction of inspired oxygen ≥0.30 (for infants born ≤26 weeks' gestational age) or ≥0.40 (for infants born >26 weeks' gestational age) to achieve a peripheral oxygen saturation of 90-94% within 24 hours of life and good respiratory drive,

• written informed consent.

Exclusion Criteria:

• major malformations,

• late admission (after 24 hours of life),

• intubation in the delivery room,

• severe birth asphyxia,

• prolonged rupture of membranes,

• air leaks,

• no informed consent.