Intraoral 30% Glucose Effect In Newborns

Study Overview
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Brief Summary
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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
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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.

Official Title
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Baskent University Institutional Review Board

Conditions
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Epilepsy, Hydrocephaly

Intervention / Treatment
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* Drug: 30% Glucose
* Drug: Midazolam


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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoral 30% Glucose in Newborns<br>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. | Drug: 30% Glucose<br>* ORAL 30% GLUCOSE 0,5-2 ML<br>* Other names: POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71;Drug: Midazolam<br>* INTRAVENOUS 0.1 MG/KG MIDAZOLAM<br>* Other names: ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborn provided qualitative images for MRI following oral glucose administration |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoral 30% glucose, newborn, MRI