Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02645279

Enrollment

112

Registered

2016-01-01

Start date

2015-01-31

Completion date

2016-02-29

Last updated

2016-01-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Trauma, Metabolic Disease

Keywords

newborn, MRI, oral 30% glucose

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.

Interventions

OTHERoral 30% glucose

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.

DRUGIV midazolam

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Approximately 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026