Effectiveness of the Fentanyl in continuous infusion in the newborns in mechanical ventilation - NEO 01/2005

• Conditions: intubation of the respiratory tract; MedDRA version: 6.1Level: PTClassification code 10002093

• Registration Number: EUCTR2005-006140-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Newborns of EG < 32 weeks, age < 72 hours, in mechanical ventilation (VM), within 24 hours from the beginning of the mechanical ventilation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Great malformations;

Asphyxia;

Strict IVH;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified