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NCT01352481 Clinical Trial

Early Intervention in Very Preterm Children

Prematurity Clinical Trial

Official title:
Early Intervention for Speech Sound Disorder in Very Preterm Children

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01352481
Other study ID # NL33278.078.10
Secondary ID
Status Recruiting
Phase N/A
First received May 10, 2011
Last updated May 11, 2011
Start date April 2011

Study information
Verified date May 2011
Source Erasmus Medical Center
Contact IL Van Noort-van der Spek
Email i.vanderspek@erasmusmc.nl
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial Summary

- The aim of the present study is to examine the effectiveness of a short, highly structured parent based speech intervention program on speech development in very preterm children with a Speech Sound Disorder (SSD) at 2 years of age.

- The hypothesis of this study is that early intervention on speech development is effective in improving the speech development in preterm children with SSD at 2 years of age compared to a no treatment group (usual care at this age).

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 24 Months to 27 Months
Eligibility Inclusion Criteria:

- birth weight < 1500 grams or gestational age < 32 weeks

- singleton birth

- no major neurodevelopmental disabilities, and

- Dutch speaking family background

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Early parent-based speech intervention program
Seven 1h sessions during a three-month period.

Locations
Country Name City State
Netherlands Erasmus Medical University Center Rotterdam

Sponsors (1)
Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of acquired consonants produced by the child 12 months after the onset of treatment No
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