Establishment of a procedure for the safe conduct of MRI examinations without sedation in premature and newborn infants.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033465

Enrollment

Registered

2025-03-10

Start date

2025-03-24

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

MRI examination without sedation

Interventions

Group 1: 20 premature and newborn infants up to a (corrected) age of 4 weeks. As part of this study, an MRI scan will be performed on 20 premature and newborn babies without sedation. This is done by

Eligibility

Sex/Gender

All

Age

No minimum to 4 Weeks

Inclusion criteria

Inclusion criteria: Indication for elective MRI examination confirmed, infant is undergoing inpatient treatment, written consent from legal guardians

Exclusion criteria

Exclusion criteria: Cardiorespiratory instability, e.g., malformations/diseases of the respiratory tract

Design outcomes

Primary

Measure	Time frame
After the MRI examination, a data collection form is used to record whether the examination was successful. The aim is to achieve a percentage of children with a successful MRI examination without sedation of over 80%.	—

Secondary

Measure	Time frame
Examination duration, preparation time, image quality, sequence repetition rate, quality of MRI sequences.	—

Countries

Germany

Contacts

Public ContactChristoph Hünseler

Uniklinik Köln

christoph.huenseler@uk-koeln.de+49221 47842514

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026