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
About this trial
This is an interventional supportive care trial for Epilepsy focused on measuring Intraoral 30% glucose, newborn, MRI
Eligibility Criteria
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
NCT ID
NCT02325583
First Posted
December 17, 2014
Last Updated
December 25, 2014
Sponsor
Baskent University
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
background
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Intraoral 30% Glucose Effect In Newborns
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