Exploratory Propofol Dose Finding Study In Neonates.

• Conditions: Investigation of the most effective intravenously administered single propofol dose for successful INSURE prodecure and for (semi-)elective intubation of neonates in non-INSURE conditions (e.g. surgery) in neonates. INSURE-procedure is defined as (semi-)elective intubation, intratracheal administration of surfactant and extubation within 60 minutes after propofol administration.; MedDRA version: 16.0Level: LLTClassification code 10028977Term: NeonateSystem Organ Class: 100000004869; MedDRA version: 16.0Level: PTClassification code 10067450Term: Endotracheal intubationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.0Level: LLTClassification code 10049124Term: Sedation during medical procedureSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.0Level: PTClassification code 10061134Term: Drug level therapeuticSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-002648-26-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-23
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Neonates admitted to the Neonatal Intensive Care Unit who need short procedural sedation for (semi-) elective intubation will be considered for inclusion, after informed written consent of the parents. Patients can be included if they are hemodynamicaly stable and did not receive sedative or analgesic agents during the previous 24 hours.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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

Known propofol intolerance
Exclusion based on opinion of attending physician

Study & Design

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