CClinicalTrials.gg
Status unknownNCT00952354Updated Aug 6, 2009

Oral Language in Children With Down Syndrome

An observational study in Down Syndrome, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 3 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-06.

Sponsored by University of Sao Paulo · Observational

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
3 Years to 10 Years
Sex
All
01

Study summary

The objective of this research is to verify the language of children with Down syndrome concerning lexical, syntactic and semantic aspects using MLU. The hypothesis is that children with Down syndrome will present low performance, regarding not only the quantitative measures as MLU-m, MLU-w, GM-1 and GM-2, but also regarding the qualitative aspects of their production, when compared to children with typical development.

Read the detailed description

One of the alternatives to observe and assess language development and language disorders is to analyze spontaneous language samples, which allos the identification of qualitative and quantitative aspects. The analysis involves the MLU-morphemes, MLU-words and words classes. All words produced are analyzed, including interjections, adverbs and adjectives.Word classes with grammatical characteristics present lower averages, as prepositions and conjunctions. Reference parameters are the ones of the spoken language. The objective assessment with qualitative and quantitative data may help the speech and language pathologist/therapist to determine therapeutic guidelines to each patient.

02

Conditions studied

  • Down Syndrome

Keywords

  • Down syndrome
  • MLU
  • language development
  • language assessment
03

In context

Down Syndrome

432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.

This study's planned enrollment of 60 is below the median of 150 across 141 observational studies indexed under Down Syndrome.

Browse Down Syndrome studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

60 children with Down syndrome aged from 3 to 10 years

Inclusion criteria

  • genetic diagnosis of Down syndrome
  • good health conditions
  • normal results on audiologic evaluation
  • pediatric and ear, nose and throat periodic check ups.
  • attend speech-language therapy at the Speech Language Pathology Laboratory in Syndromes and Sensorimotor Deficits (SLPL-SSD) of the School of Medicine of the University of São Paulo.

Exclusion criteria

Exclusion Criteria:

  • submission to long term hospitalizations due to heart diseases and major respiratory airway infections, that may interfere in the child's global development
  • presence of visual or auditory important deficits
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)

Groups and cohorts

  • research group

    60 children aged from 3 to 10 years, both genders, observed in a symbolic play situation with their language therapists

06

Study locations

1 site
  • University of Sao Paulo - School of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
    Sao Paulo, 05360-160, Brazil
07

References and documents

Publications

  • Limongi SC, Oliveira Ede F, Ienne LM, Andrade RV, Carvalho AM. The use of nouns and verbs by children with Down syndrome in two different situations. Codas. 2013;25(3):262-7. doi: 10.1590/s2317-17822013000300012. English, Portuguese. PubMed 24408338 ↗
  • Marques SF, Limongi SC. [Mean length utterance (MLU) as a measure of language development of children with Down syndrome]. J Soc Bras Fonoaudiol. 2011;23(2):152-7. doi: 10.1590/s2179-64912011000200012. Portuguese. PubMed 21829931 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00952354
Lead sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted
Aug 6, 2009
Start date
Aug 2007
Primary completion
Apr 2009
Completion
Aug 2009 (estimated)
Last update
Aug 6, 2009

Study contacts

Suelly CO Limongi, PhD
study chair · University of Sao Paulo
Rosangela V Andrade, PhD
principal investigator · University of Sao Paulo
Fabiola C Flabiano, PhD student
principal investigator · University of Sao Paulo
Porto Eliza, Ms student
principal investigator · University of Sao Paulo
Angela MA Carvalho, Ms student
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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