EpilepsyPhase 4NCT02645279
Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
A Phase 4 study testing oral 30% glucose and IV midazolam in people with Epilepsy and Trauma, run by Baskent University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Epilepsy, Trauma, Metabolic Disease
- What is being tested?
- oral 30% glucose and IV midazolam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates requiring MR imaging for diagnosis
Who cannot join
- Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
About this study
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.
Read the 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
- Epilepsy, Trauma, Metabolic Disease
- Being tested
- oral 30% glucose, IV midazolam
- Keywords
- newborn, MRI, oral 30% glucose
- Medical subject headings
- Epilepsy, Wounds and Injuries, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral 30% glucoseOther
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.
IV midazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| oral 30% glucose | Active comparator | oral 30% glucose total 200 mg/kg with 0.5-1 mL increments Receives: Other: oral 30% glucose |
| IV midazolam | Active comparator | intravenous administration of midazolam 0.1 mg/kg Receives: Drug: IV midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Evren Eker, Baskent University
- Investigators
- Anis Aribogan, Prof, Study chair, Baskent University Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645279
- Sponsor's protocol ID
- KA15/19
- Status last verified
- Dec 2015
- First submitted
- 30 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
- ClinicalTrials.gov ID
- NCT02645279
- Acronym / sponsor ID
- KA15/19
- Conditions
- Epilepsy, Trauma, Metabolic Disease
- Keywords
- newborn, MRI, oral 30% glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral 30% glucose | Active comparator | Other: oral 30% glucoseoral 30% glucose total 200 mg/kg with 0.5-1 mL increments |
| IV midazolam | Active comparator | Drug: IV midazolamintravenous administration of midazolam 0.1 mg/kg |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates requiring MR imaging for diagnosis
Key exclusion criteria (1 listed)
- Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral 30% glucose30% 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. | Other | oral 30% glucose |
| IV midazolamIV 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. | Drug | IV midazolam |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anis Aribogan, Prof study chair
Baskent University Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral 30% glucose and IV midazolam in people with Epilepsy and Trauma, run by Baskent University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.