## Protocol Section
### Identification Module
**NCT ID:** NCT02645279

**Brief Title:** Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

**Official Title:** Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

#### Organization Study ID Info
**ID:** KA15/19
#### Organization
**Class:** OTHER
**Full Name:** Baskent University
### Status Module
#### Completion Date
**Date:** 2016-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ACTIVE_NOT_RECRUITING
#### Last Update Post Date
**Date:** 2016-01-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-31

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2016-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2015-12

#### Study First Post Date
**Date:** 2016-01-01
**Type:** ESTIMATED
**Study First Submit Date:** 2015-12-30
**Study First Submit QC Date:** 2015-12-31
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Baskent University

#### Responsible Party

**Investigator Affiliation:** Baskent University

**Investigator Full Name:** H. Evren Eker

**Investigator Title:** Ass Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.

**Detailed Description:** Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.

### Conditions Module

**Conditions:**

- Epilepsy

- Trauma

- Metabolic Disease

**Keywords:**

- newborn

- MRI

- oral 30% glucose

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 112

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** oral 30% glucose total 200 mg/kg with 0.5-1 mL increments

**Intervention Names:**

- Other: oral 30% glucose

**Label:** oral 30% glucose

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** intravenous administration of midazolam 0.1 mg/kg

**Intervention Names:**

- Drug: IV midazolam

**Label:** IV midazolam

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- oral 30% glucose

**Description:** 30% glucose solution was administered orally through a teat. 1 mL 30% glucose solution was added following placement of the teat into the mouth of the newborn. After suckling of 0.5-1 mL glucose solution, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added until the newborn kept motionless or asleep.

**Name:** oral 30% glucose

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- IV midazolam

**Description:** IV 0.1 mg/kg midazolam was administered.MRI was routinely performed and the newborns who did not keep motionless or asleep and had motion artefacts were sedated with intravenous 0.5 mg/kg propofol.

**Name:** IV midazolam

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation

**Time Frame:** Approximately 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Neonates requiring MR imaging for diagnosis

Exclusion Criteria:

* Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations

**Maximum Age:** 30 Days

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Baskent University Department of Anesthesiology

**Name:** Anis Aribogan, Prof

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M7983

- Name: Epilepsy

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: HIGH

- As Found: Metabolic Diseases

### Condition Browse Module - Meshes

- ID: D000008659

- Term: Metabolic Diseases

### Intervention Browse Module - Ancestors

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000018757

- Term: GABA Modulators

- ID: D000018682

- Term: GABA Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M11845

- Name: Midazolam

- Relevance: HIGH

- As Found: Induction

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20827

- Name: GABA Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008874

- Term: Midazolam

### Misc Info Module

- Version Holder: 2024-05-24
