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

• Status: Withdrawn
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASST Fatebenefratelli Sacco
• Collaborator: Gianluca Lista
• Treatments: Atropine; Fentanyl

Criteria

Inclusion Criteria:

• Preterm neonate 27-29+6 weeks AND

• Need for non-invasive respiratory support (CPAP or nHFT) AND

• Need for surfactant according to the unit guidelines AND

• Written informed consent

Exclusion Criteria:

• No written informed consent and/or

• Severe malformation of the upper/lower airways, brain and/or heart and/or lung and/or prenatal cerebral injury.