drugset / Trial / NCT03718507

Study on the Effects of Different Premedication for LISA on Stress and Cerebral Tissue Oxygenation in Preterm Infants

NCT03718507

Phase 1 Withdrawn ASST Fatebenefratelli Sacco
RandomizedParallel-groupOpen-labelSupportive care

Summary

Given the popularity that LISA technique has gainig in worldwide neonatal units, the lack of evidence regarding its premedication is becoming even more relevant to provide the best care to premature infants. Objective of this clinical trial is to establish the best premedication for LISA procedure considering neonatal pain assessed with premature infants pain scale, salivary cortisol levels as an indicator of stress and crSO2 values as indicators of cerebral oxygenation. Moreover, we aim to verify if sucrose 24% given orally is an effective tool for pain management in preterm neonates also in more invasive procedure, comparable to pharmacological treatment.

Timeline

Start
2019-05-20
Primary completion
2019-12-20
Completion
2020-02-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 0.5 ug/kg Intravenous
Comparator Fentanyl Other / unclassified 2 ug/kg Intravenous
Subject Sucrose Small molecule 0.5 ml Oral
Background Atropine Other / unclassified 0.01 mg/kg Intravenous
Background Atropine Other / unclassified 0.02 mg/kg Intravenous