Intraoral 30% Glucose Effect In Newborns

NCT02325583 | Completed Phase 3 DMC

• 1 other identifier: KA14/299
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy; Hydrocephaly

Keywords

Intraoral 30% glucose, newborn, MRI

Outcome Measures

Primary Outcomes (1)

• Number of newborn provided qualitative images for MRI following oral glucose administration

  10 months

Study Arms (1)

Intraoral 30% Glucose in Newborns

EXPERIMENTAL

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; Drug: Midazolam

Interventions

30% Glucose DRUG

ORAL 30% GLUCOSE 0,5-2 ML

Also known as: POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71

Intraoral 30% Glucose in Newborns

Midazolam DRUG

INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Also known as: ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036

Intraoral 30% Glucose in Newborns

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns admitted from newborn intensive care unit for MR imaging

You may not qualify if:

• Intubated newborns

Sponsors & Collaborators

• Baskent University: lead

Related Publications (1)

• 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.

  PMID: 9055897 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Hydrocephalus

Interventions

Glucose; Midazolam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocciate Professor

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 25, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 30, 2014

Record last verified: 2014-12