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Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation (NEOPROP2)

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ClinicalTrials.gov Identifier: NCT02040909
Recruitment Status : Terminated (interim results concluded no added value of additional inclusion)
First Posted : January 20, 2014
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
VU University Medical Center
Maxima Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Nuts Ohra
Information provided by (Responsible Party):
Sinno H.P. Simons, Erasmus Medical Center

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.


Condition or disease Intervention/treatment Phase
Anesthesia Intubation Complication Premature Birth of Newborn Other Preterm Infants Propofol Overdose Drug: Propofol Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Propofol Dosing for (Preterm) Newborn Infants That Need Endotracheal Intubation
Actual Study Start Date : July 2014
Actual Primary Completion Date : January 23, 2018
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Propofol
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
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.
Other Name: Diprivan




Primary Outcome Measures :
  1. adequate propofol dose [ Time Frame: 24 hours ]

    Adequate propofol doses are determined by 3 co-primary outcome variables:

    • Adequate sedation
    • Optimal intubation conditions
    • No hypotension or other severe side effects


Secondary Outcome Measures :
  1. Determine a valid sedation assessment scale [ Time Frame: 24 hours ]
    To develop a validated and useful sedation assessment instrument for (preterm) newborns during endotracheal intubation. For this aim validated pain assessment instruments (COMFORTneo, neonatal Pain And Sedation Scale, Premature Infant Pain Profile and Neonatal Infant Pain Scale will be compared with an available sedation score by the use of videotapes. Furthermore we aim to determine the relationship between these pain and sedation scores with the patients stress level as measured by cortisol levels.

  2. to determine an age specific propofol PK/PD model [ Time Frame: 24 hours ]
    Pharmacodynamic data of propofol are explored (duration of intubation, duration of sedation, time of side effect, recovery of spontaneous breathing). We will analyze propofol concentrations in a pharmacokinetic model and integrate pharmacodynamic data (level of sedation, side effects) and covariates (age, weight, morbidity, etc). We aim to determine effective propofol concentrations and concentrations that might result in side-effects.

  3. aEEG / NIRS [ Time Frame: 24 hours ]
    -To further explore dose and age-related hemodynamic effects of propofol. Next to blood pressure and heart rate cerebral oxygenation and continuous amplitude-integrated EEG (aEEG) will be monitored. After the intubation procedure, when the patient is still sedated the cerebral perfusion is measured using cerebral Doppler sonography. In this way we aim to determine the effects of propofol on cerebral perfusion. Risk factors for hypotension and cerebral hypoperfusion are determined.


Other Outcome Measures:
  1. Propofol polymorphisms on effect and metabolizing enzymes [ Time Frame: 1 year ]
    To further explain expected inter-individual variability in propofol concentrations and effects by adding genotypic variability to the PK/PD model. Polymorphisms in genes encoding propofol metabolizing enzymes (UGT 1A9 and Cytochrome P450 2B6) and GABA (gamma-aminobutyric acid) receptors will be analysed in the patients DNA



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All neonates admitted to the two participating intensive care units:

  • Less than 28 days postnatal age
  • Who need endotracheal intubation

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040909


Locations
Netherlands
VU Medical Center
Amsterdam, Netherlands, 1081HZ
Erasmus MC Sophia Children's Hospital
Rotterdam, Netherlands, 3000CB
Maxima Medisch Centrum
Veldhoven, Netherlands, 5504 DB
Sponsors and Collaborators
Erasmus Medical Center
VU University Medical Center
Maxima Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Stichting Nuts Ohra
Investigators
Study Director: Mirjam van Weissenbruch, MD PhD VU Medical Center Amsterdam

Responsible Party: Sinno H.P. Simons, Dr.S.H.P. Simons, pediatrician-neonatologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02040909     History of Changes
Other Study ID Numbers: 20132312
2013-005572-17 ( EudraCT Number )
90713494 ( Other Grant/Funding Number: ZonMW )
1201-020 ( Other Grant/Funding Number: fondsNutsOhra )
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Keywords provided by Sinno H.P. Simons, Erasmus Medical Center:
sedation
quality of intubation
hypotension
pharmacodynamics
pharmacokinetics

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics