Overview

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