MedTrace Logo

Exploratory Propofol Dose Finding Study In Neonates

NCT01621373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-07-30

Study results available
· View outcomes & findings →

Summary

The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure (preterm neonates) and (semi-)elective non-INSURE procedures (term-preterm neonates).

Conditions

  • Adverse Reaction to Drug
  • Neonatal Disorder

Interventions

DRUG

propofol administration

Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Liesbeth Thewissen, MD · UZ Leuven, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621373 on ClinicalTrials.gov