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Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

Primary Purpose

Epilepsy, Trauma, Metabolic Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
oral 30% glucose
IV midazolam
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy focused on measuring newborn, MRI, oral 30% glucose

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neonates requiring MR imaging for diagnosis

Exclusion Criteria:

  • Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    oral 30% glucose

    IV midazolam

    Arm Description

    oral 30% glucose total 200 mg/kg with 0.5-1 mL increments

    intravenous administration of midazolam 0.1 mg/kg

    Outcomes

    Primary Outcome Measures

    Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2015
    Last Updated
    December 31, 2015
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645279
    Brief Title
    Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
    Official Title
    Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    February 2016 (Anticipated)
    Study Completion Date
    February 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baskent University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.
    Detailed Description
    Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy, Trauma, Metabolic Disease
    Keywords
    newborn, MRI, oral 30% glucose

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    112 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oral 30% glucose
    Arm Type
    Active Comparator
    Arm Description
    oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
    Arm Title
    IV midazolam
    Arm Type
    Active Comparator
    Arm Description
    intravenous administration of midazolam 0.1 mg/kg
    Intervention Type
    Other
    Intervention Name(s)
    oral 30% glucose
    Intervention Description
    30% glucose solution was administered orally through a teat. 1 mL 30% glucose solution was added following placement of the teat into the mouth of the newborn. After suckling of 0.5-1 mL glucose solution, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added until the newborn kept motionless or asleep.
    Intervention Type
    Drug
    Intervention Name(s)
    IV midazolam
    Intervention Description
    IV 0.1 mg/kg midazolam was administered.MRI was routinely performed and the newborns who did not keep motionless or asleep and had motion artefacts were sedated with intravenous 0.5 mg/kg propofol.
    Primary Outcome Measure Information:
    Title
    Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation
    Time Frame
    Approximately 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    30 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Neonates requiring MR imaging for diagnosis Exclusion Criteria: Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anis Aribogan, Prof
    Organizational Affiliation
    Baskent University Department of Anesthesiology
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

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