Intraoral 30% Glucose Effect In Newborns

Epilepsy Clinical Trial

Official title:

Baskent University Institutional Review Board

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325583
• Other study ID #: KA14/299
• Status: Completed
• Phase: Phase 3
• First received: December 17, 2014
• Last updated: December 25, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria:

• Intubated newborns

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Epilepsy
• Hydrocephaly

Intervention

Drug:
• 30% Glucose
ORAL 30% GLUCOSE 0,5-2 ML
• Midazolam
INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

References & Publications (1)

Skogsdal Y, Eriksson M, Schollin J. Analgesia in newborns given oral glucose. Acta Paediatr. 1997 Feb;86(2):217-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of newborn provided qualitative images for MRI following oral glucose administration		10 months	Yes