NCT02040909

Brief Summary

Newborns admitted to an intensive care unit often require artificial ventilation. For that purpose an endotracheal tube needs to be placed into the trachea, a procedure named endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop moving and to relax in order to enable the success of the procedure. For this sedation an anesthetic agent named propofol is often used. The used dose of propofol has not been properly studied and as a consequence patients are under- or over -sedated and propofol leads to side effects such as hypotension. The current study aims to find the most appropriate dose of propofol for newborns of different gestational ages and of different post-natal ages. We will use propofol in different doses and after each 5 included patients per age group we will analyze whether the dose needs to be increased or decreased. The effect of the propofol will be extensively monitored and we will study the level of sedation, the quality of intubation, the stability of the patient en the occurrence of side effects. At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2014

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

December 23, 2013

Last Update Submit

January 31, 2018

Conditions

Anesthesia Intubation ComplicationPremature Birth of NewbornOther Preterm InfantsPropofol Overdose

Keywords

sedationquality of intubationhypotensionpharmacodynamicspharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • adequate propofol dose

    Adequate propofol doses are determined by 3 co-primary outcome variables: * Adequate sedation * Optimal intubation conditions * No hypotension or other severe side effects

    24 hours

Secondary Outcomes (3)

  • Determine a valid sedation assessment scale

    24 hours

  • to determine an age specific propofol PK/PD model

    24 hours

  • aEEG / NIRS

    24 hours

Other Outcomes (1)

  • Propofol polymorphisms on effect and metabolizing enzymes

    1 year

Study Arms (1)

Propofol

EXPERIMENTAL

A predetermined propofol dose is used in every 5 consecutive patients per age group. Starting dose is 1.0 mg/kg. Dose is increased or decreased with 0.5 mg/kg

Drug: Propofol

Interventions

PropofolDRUG

Propofol, an anesthetic agent, is used to sedate the patients before endotracheal intubation. The propofol starting dose in all age groups will be 1.0 mg propofol/kg. After 5 patients per age group the next dose will be determined. Dose will be increased or decreased with 0.5 mg/kg for the next 5 patients. The study will be continued untill an adequate dose, that results in adequate sedation, good intubation conditions without hypotension, is determined. That dose will be valideted in another 5 patients per age group.

Also known as: Diprivan
Propofol

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All neonates admitted to the two participating intensive care units:
  • Less than 28 days postnatal age
  • Who need endotracheal intubation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VU Medical Center

Amsterdam, 1081HZ, Netherlands

Location

Erasmus MC Sophia Children's Hospital

Rotterdam, 3000CB, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5504 DB, Netherlands

Location

MeSH Terms

Conditions

Premature BirthHypotension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mirjam van Weissenbruch, MD PhD

    VU Medical Center Amsterdam

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.S.H.P. Simons, pediatrician-neonatologist

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 20, 2014

Study Start

July 1, 2014

Primary Completion

January 23, 2018

Study Completion

January 23, 2018

Last Updated

February 1, 2018

Record last verified: 2018-01

Locations

NL(3)