Status:
UNKNOWN
Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants.
Lead Sponsor:
Virgilio Paolo Carnielli
Collaborating Sponsors:
Fondazione Cassa di Risparmio di Verona Vicenza Belluno e Ancona
Istituto di Ricerca Pediatrica Città della Speranza
Conditions:
Respiratory Distress Syndrome in Premature Infants
Eligibility:
All Genders
168-223 years
Phase:
PHASE4
Brief 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 d...
Detailed Description
At present, LISA and INSURE are both used for surfactant therapy in infants as comparable methods. However, a clear policy of using analgesics during surfactant therapy is still lacking: some neonatol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04073173
Start Date
November 1 2020
End Date
October 31 2022
Last Update
September 3 2020
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