Back to resultsEarly Intervention in Very Preterm Children
Primary Purpose
Prematurity, Speech Sound Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Early parent-based speech intervention program
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity focused on measuring Speech sound development
Eligibility Criteria
Inclusion Criteria:
- birth weight < 1500 grams or gestational age < 32 weeks
- singleton birth
- no major neurodevelopmental disabilities, and
- Dutch speaking family background
Sites / Locations
- Erasmus Medical University CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Number of acquired consonants produced by the child
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01352481
Brief Title
Early Intervention in Very Preterm Children
Official Title
Early Intervention for Speech Sound Disorder in Very Preterm Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Erasmus Medical Center
4. Oversight
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Speech Sound Disorder
Keywords
Speech sound development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Early parent-based speech intervention program
Other Intervention Name(s)
Prematurity, Speech Sound Disorder, Early Intervention
Intervention Description
Seven 1h sessions during a three-month period.
Primary Outcome Measure Information:
Title
Number of acquired consonants produced by the child
Time Frame
12 months after the onset of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
27 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
birth weight < 1500 grams or gestational age < 32 weeks
singleton birth
no major neurodevelopmental disabilities, and
Dutch speaking family background
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IL Van Noort-van der Spek
Email
i.vanderspek@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
MCJP Franken
Email
m.franken@erasmusmc.nl
Facility Information:
Facility Name
Erasmus Medical University Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
van Noort-van der Spek
Phone
+31107036073
First Name & Middle Initial & Last Name & Degree
RJ Baatenburg de Jong
12. IPD Sharing Statement
Learn more about this trial
Early Intervention in Very Preterm Children
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