Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intraoral 30% Glucose Effect In Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02325583
Recruitment Status : Completed
First Posted : December 25, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
H. Evren Eker, Baskent University

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.

Condition or disease Intervention/treatment Phase
Epilepsy Hydrocephaly Drug: 30% Glucose Drug: Midazolam Phase 3

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Baskent University Institutional Review Board
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014


Arm Intervention/treatment
Experimental: 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.
Drug: 30% Glucose
ORAL 30% GLUCOSE 0,5-2 ML
Other Name: POLİFLEKS %30 DEKSTROZ POLİFARMA İLAÇ 05.10.2014/204-71

Drug: Midazolam
INTRAVENOUS 0.1 MG/KG MIDAZOLAM
Other Name: ZOLAMİD 5 MG/ML, DEFARMA İLAÇ SAN, 406036




Primary Outcome Measures :
  1. Number of newborn provided qualitative images for MRI following oral glucose administration [ Time Frame: 10 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns admitted from newborn intensive care unit for MR imaging

Exclusion Criteria:

  • Intubated newborns

Publications:
Layout table for additonal information
Responsible Party: H. Evren Eker, Assocciate Professor, Baskent University
ClinicalTrials.gov Identifier: NCT02325583    
Other Study ID Numbers: KA14/299
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by H. Evren Eker, Baskent University:
Intraoral 30% glucose, newborn, MRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action