Continuous Infusion of Fentanyl in Preterm on MV

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this randomized, double-blind trial is to compare the efficacy and safety of 2 therapeutic regimens of fentanyl administration in a population of preterm newborns of GA <= 32 weeks in MV:

• Group A) continuous infusion of Fentanyl + open label boluses of Fentanyl;

• Group B) continuous infusion of placebo + open label boluses of Fentanyl.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna; St. Orsola Hospital
• Collaborator: Agenzia Italiana del Farmaco
• Treatments: Fentanyl

Criteria

Inclusion Criteria:

• inborn neonates

• preterm neonates ≤ 32+ 6 days weeks gestation

• < 72 hours of life

• newborns on MV

• within 24 hours from the beginning of MV administered through an endotracheal tube

• parental written informed consent for participation in the study must be obtained

Exclusion Criteria:

• Evidence of severe birth asphyxia, that is an APGAR score below 4 at 5 minutes of age and/or umbilical arterial pH < 7.0

• Known genetic or chromosomal disorders

• Severe IVH (> grade II according to Volpe classification (30))

• Need for post-operative analgesic therapy in the first week of life

• Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol