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Intraoral 30% Glucose Effect In Newborns

Primary Purpose

Epilepsy, Hydrocephaly

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
30% Glucose
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 Intraoral 30% glucose, newborn, MRI

Eligibility Criteria

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

Inclusion Criteria:

  • Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria:

  • Intubated newborns

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intraoral 30% Glucose in Newborns

    Arm Description

    0.5-1 mL 30% glucose solution was administered orally and the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added. After 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. The routine blood glucose level measurement was also performed in ICU.

    Outcomes

    Primary Outcome Measures

    Number of newborn provided qualitative images for MRI following oral glucose administration

    Secondary Outcome Measures

    Full Information

    First Posted
    December 17, 2014
    Last Updated
    December 25, 2014
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02325583
    Brief Title
    Intraoral 30% Glucose Effect In Newborns
    Official Title
    Baskent University Institutional Review Board
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Newborn often sedated during MRI but sedation itself creates adverse events and management is more challenging in the MR environment. The investigators describe the investigators initial experience with oral 30% glucose administration through a pacifier during MRI for imaging of newborns. Using this technique, majority of newborns can complete MRI examination without the need for sedation and also offers the availability of administering sedatives to unsuccessful patients.
    Detailed Description
    19 consecutive newborns over 10 months period were assessed retrospectively. 0.5-1 mL 30% glucose solution was administered orally and after suckling, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added. After 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. The outcome measure was the success of the procedure which was determined by providing qualitative images appropriate for interpretation following 30% glucose administration. The routine blood glucose level measurement of the newborns after imaging procedures in the ICU was also performed for each patient.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intraoral 30% Glucose in Newborns
    Arm Type
    Experimental
    Arm Description
    0.5-1 mL 30% glucose solution was administered orally and the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added. After 2 consecutive oral glucose administration the newborns who did not keep motionless or sleep and had motion artefacts sedated with midazolam. The routine blood glucose level measurement was also performed in ICU.
    Intervention Type
    Drug
    Intervention Name(s)
    30% Glucose
    Other Intervention Name(s)
    POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71
    Intervention Description
    ORAL 30% GLUCOSE 0,5-2 ML
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Other Intervention Name(s)
    ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036
    Intervention Description
    INTRAVENOUS 0.1 MG/KG MIDAZOLAM
    Primary Outcome Measure Information:
    Title
    Number of newborn provided qualitative images for MRI following oral glucose administration
    Time Frame
    10 months

    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: Newborns admitted from newborn intensive care unit for MR imaging Exclusion Criteria: Intubated newborns

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9055897
    Citation
    Skogsdal Y, Eriksson M, Schollin J. Analgesia in newborns given oral glucose. Acta Paediatr. 1997 Feb;86(2):217-20. doi: 10.1111/j.1651-2227.1997.tb08872.x.
    Results Reference
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    Intraoral 30% Glucose Effect In Newborns

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