Intraoral 30% Glucose Effect In Newborns

Phase 3

Completed

• Conditions: Epilepsy; Hydrocephaly
• Interventions: Drug: 30% Glucose; Drug: Midazolam

• Registration Number: NCT02325583
• Lead Sponsor: Baskent University

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Last Update Submitted: 2014-12-25
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Newborns admitted from newborn intensive care unit for MR imaging

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Exclusion Criteria

• Intubated newborns

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoral 30% Glucose in Newborns	30% Glucose	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.
Intraoral 30% Glucose in Newborns	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Number of newborn provided qualitative images for MRI following oral glucose administration	10 months