- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03315416
Infant Feeding, Non-nutritive Sucking and Speech Development
The Effect of Different Feeding Methods and Non-nutritive Sucking Behaviours on Child Speech Development
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
In the UK every year around 48,000 children aged 2-5 years are referred to NHS Speech & Language Therapy (SLT) services with difficulties using the right sounds in their talking. This is known as speech sound disorders (SSD). This is the largest population seen by Speech and Language Therapists and costs the NHS about £24 million per year.
Children with SSD are more at risk of mental health problems and difficulties making relationships with those around them. They are also more likely to struggle with learning at school and be involved with the criminal justice system at some point in their early lives. When a baby is born parents make different choices about feeding their baby. Some breastfeed, some bottle-feed and some use a mixture of both. Some babies also like to have a dummy, while others suck their hand and some don't suck anything. Some studies have found that breastfeeding is linked to better language and learning in later childhood, while others have found that dummy sucking has the opposite effect.
However, the effect that different types of feeding have on speech development has not been looked at in as much detail.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Samantha L Burr
- Phone Number: 07721 211 928
- Email: Sam.Burr@uwe.ac.uk
Study Locations
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Southampton, United Kingdom, SO19 8BR
- Recruiting
- Solent NHS Trust
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Contact:
- Samantha L Burr, MSc
- Phone Number: 07721 211 928
- Email: Sam.Burr@uwe.ac.uk
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Principal Investigator:
- Samantha L Burr, MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 2;0-5;6 on current speech and language therapy clinical caseloads in Hampshire (Solent NHS Trust) who have a diagnosis of speech sound disorder.
Exclusion Criteria:
- Genetic Disorder (including Downs Syndrome and other identified syndromes) Other congenital anomaly (e.g Cerebral Palsy, Global Developmental Delay) Diagnosed Learning Disability Permanent Hearing Loss (Sensorineural) Cleft lip and/or palate and/or submucous cleft palate Premature birth (before 37 completed weeks gestation) English as second or additional language
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NHS Sample
Children diagnosed with speech sound disorder aged 2-5 years
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Formal standardised speech sound assessment typically used as part of standard NHS care by Speech and language Therapists
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Consonants Correct (PCC) on a single word naming test.
Time Frame: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
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PCC is a speech sound articulation test used to measure the number of correct consonant sounds produced compared to the number of consonant sounds attempted.
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Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of developmental and non-developmental error patterns in speech.
Time Frame: Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
|
There are a variety of sound changes (error patterns) that feature in typical speech sound development.
There are also patterns that are characteristic of atypical speech sound development.
The speech samples gained from using the Diagnostic Evaluation of Articulation and Phonology (DEAP) speech assessment will be analysed by a qualified Speech and Language Therapist to identify atypical speech errors.
These will then be quantified for use in the statistical analysis.
|
Outcome will be determined from data gained from the participants through assessment on a single clinic visit following recruitment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samantha L Burr, Solent NHS Trust
- Study Director: Toity Deave, Dr, University of the West of England
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICA-CDRF-2016-02-053
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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