Intraoral 30% Glucose Effect In Newborns

Baskent University

Status and phase: Completed; Phase 3

Conditions: Epilepsy; Hydrocephaly

Treatments: Drug: Midazolam; Drug: 30% Glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT02325583

KA14/299

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborns admitted from newborn intensive care unit for MR imaging

Exclusion criteria

• Intubated newborns

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Intraoral 30% Glucose in Newborns

Experimental group

Description:

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.

Treatment:

Drug: 30% Glucose

Drug: Midazolam