NCT02325583

Intraoral 30% Glucose Effect In Newborns

Baskent University Institutional Review Board

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Baskent University · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy
• Hydrocephaly

Interventions

Type	Name	Description
DRUG	30% Glucose	ORAL 30% GLUCOSE 0,5-2 ML
DRUG	Midazolam	INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-12-25
• Last updated: 2014-12-30