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Do children with a Pierre Robin Sequence have a worse speech development after cleft palate repair?

Do children with a Pierre Robin Sequence have a worse speech development after cleft palate repair? - PRS-Studie

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00006831
Enrollment
60
Registered
2014-11-03
Start date
2015-04-22
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Q87.0 Q35.5

Interventions

Group 1: Children with cleft palate: Questionnaire about milestones in development, neuropsychological tests WPPSI-III and K-ABC-SED, neurological examination, audio and image recordings of speech on

Sponsors

Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 6 Years

Inclusion criteria

Inclusion criteria: Group 1: Patients with Piere Robin Sequenz and cleft palate Group 2: Patients with isolated cleft palates For both groups: 1. Ager: 5 years + 1 day to 6 years + 364 days (5 – 6 years) 2. Written approval by their legal guardians 3. cleft palate 4. Following surgery within the first 18 months of life. In addition for group 1: 5. Supply of intraoral appliance (baton plate) to 1 year

Exclusion criteria

Exclusion criteria: 1. Comorbidities 2. Additional syndrome or sequences 3. Supply of intraoral appliance (baton plate) longer than 1 year

Design outcomes

Primary

MeasureTime frame
Speech function after surgery on cleft palates at the age of 5 – 6 years according to GOSSPASS list respectively universally reporting parameters for LKGS malformation.

Secondary

MeasureTime frame
1. Comparing neurologicals development (cognitive and motor development): Spastic, dyscinetic or atactic movement disorders defined in accordance with the SCPE-criteria, questionnaire about milestones in development on the study day (visit 1) 2. Growth of mandible and midface fixation (Assessment of the occlusion grade I-III according to Angle) 3. Number of remaining gaps in the palate

Countries

Germany

Contacts

Public ContactAndreas Naros

Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen

andreas.naros@med.uni-tuebingen.de+49-(0)7071-2986174

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 12, 2026