Study to optimise the dose of the anesthetic agent propofol thatis given to newborn babies to make them asleep before a tube is putted intheir airway to start artificial ventilation. Propofol dose is optimised fornewborns of different ages.

• Conditions: Sedation for endotracheal intubation in newborns of different ages at theneonatal intensive care unit; MedDRA version: 16.1Level: LLTClassification code 10029392Term: NewbornSystem Organ Class: 100000004869; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-005572-17-NL
• Lead Sponsor: Erasmus Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-19
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

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

Inclusion Criteria

All neonates admitted to the participating intensive care units:
- Less than 28 days postnatal age
- Who need endotracheal intubation
Are the trial subjects under 18? yes
Number of subjects for this age range: 160
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

Patients with:
- Major congenital anomalies or neurological disorders,
- Neonates with an abnormal upper airway,
- Those receiving continuous sedatives or opioids, and
- Those whose mothers received sedatives or opioids before or during
delivery will be excluded during the first 2 days of life
- Those who previously participated in the study

Study & Design

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