Objectification of swallowing-related measurements in infants and young children with Spinal Muscular Atrophy

Objectification of swallowing-related measurements in infants and young children with Spinal Muscular Atrophy - OSMA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032287

Enrollment

Registered

2023-07-14

Start date

2023-08-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

G12.0

Interventions

Group 1: Infants and young children (0-24 months) with 5-q associated Spinal Muscular Atrophy (0-3 SMN2 copies) receiving any of the currently approved gene-modifying or gene-replacement therapies. -

5 neonatal electrodes. - Video endoscopic documentation of the palate height and width with a USB endoscope. - measurement of maximum jaw opening

standard scale for adults and measurement scale developed for edentulous infants. Five measurement time points (pre-therapy, 2 months, 6 months, 10 months, 18 months). Long-term follow-up of 6 months

standard scale for adults and measurement scale developed for edentulous infants. Single measurement time.

Eligibility

Sex/Gender

All

Age

No minimum to 24 Months

Inclusion criteria

Inclusion criteria: 5q Associated Spinal Muscular Atrophy (0-3 SMN2 copies). Healthy sample: No abnormalities conform early detection examination booklet

Exclusion criteria

Exclusion criteria: epilepsy Known heart problems

Design outcomes

Primary

Measure	Time frame
Frequency of swallowing saliva and food Maximum jaw opening in mm Palate height and width At all measurement times	—

Secondary

Measure	Time frame
Feasibility of the measurement methods	—

Countries

Germany

Contacts

Public ContactJana Zang

Universitätsklinikum Hamburg-Eppendorf

jana.zang@uke.de+49 (0) 40 7410- 52361

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026