Intraoral 30% Glucose Effect In Newborns

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Hydrocephalus Hydrocephaly Nervous System Diseases

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Newborns admitted from newborn intensive care unit for MR imaging

Exclusion criteria

Intubated newborns

Treatment and study plan

30% Glucose

Drug

ORAL 30% GLUCOSE 0,5-2 ML

Other names: POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71

midazolam

Drug

INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Other names: ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036

Primary outcomes

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

Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

Baskent University Institutional Review Board

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Dec 25, 2014
Registry last updated: Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed