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Intraoral 30% Glucose Effect In Newborns

NCT ID: NCT02325583

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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

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Epilepsy Hydrocephaly

Keywords

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Intraoral 30% glucose, newborn, MRI

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intraoral 30% Glucose in Newborns

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.

Group Type EXPERIMENTAL

30% Glucose

Intervention Type DRUG

ORAL 30% GLUCOSE 0,5-2 ML

Midazolam

Intervention Type DRUG

INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Interventions

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30% Glucose

ORAL 30% GLUCOSE 0,5-2 ML

Intervention Type DRUG

Midazolam

INTRAVENOUS 0.1 MG/KG MIDAZOLAM

Intervention Type DRUG

Other Intervention Names

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POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71 ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036

Eligibility Criteria

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Inclusion Criteria

* Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria

* Intubated newborns
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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H. Evren Eker

Assocciate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 9055897 (View on PubMed)

Other Identifiers

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KA14/299

Identifier Type: -

Identifier Source: org_study_id