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Early Intervention in Very Preterm Children

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ClinicalTrials.gov Identifier: NCT01352481
Recruitment Status : Unknown
Verified May 2011 by Erasmus Medical Center.
Recruitment status was:  Recruiting
First Posted : May 12, 2011
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Erasmus Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Prematurity Speech Sound Disorder Other: Early parent-based speech intervention program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention for Speech Sound Disorder in Very Preterm Children
Study Start Date : April 2011
Estimated Primary Completion Date : April 2013
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intervention group Other: Early parent-based speech intervention program
Seven 1h sessions during a three-month period.
Other Name: Prematurity, Speech Sound Disorder, Early Intervention
No Intervention: Control group Other: Early parent-based speech intervention program
Seven 1h sessions during a three-month period.
Other Name: Prematurity, Speech Sound Disorder, Early Intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of acquired consonants produced by the child [ Time Frame: 12 months after the onset of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   24 Months to 27 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • birth weight < 1500 grams or gestational age < 32 weeks
  • singleton birth
  • no major neurodevelopmental disabilities, and
  • Dutch speaking family background
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352481


Contacts
Contact: IL Van Noort-van der Spek i.vanderspek@erasmusmc.nl
Contact: MCJP Franken m.franken@erasmusmc.nl

Locations
Netherlands
Erasmus Medical University Center Recruiting
Rotterdam, Netherlands
Contact: van Noort-van der Spek    +31107036073      
Principal Investigator: RJ Baatenburg de Jong         
Sponsors and Collaborators
Erasmus Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: RJ Baatenburg de Jong, MD, PhD, Head of Department, Erasmus Medical University Center, Department of Otorhinolatyngology
ClinicalTrials.gov Identifier: NCT01352481     History of Changes
Other Study ID Numbers: NL33278.078.10
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: May 12, 2011
Last Verified: May 2011

Keywords provided by Erasmus Medical Center:
Speech sound development

Additional relevant MeSH terms:
Speech Sound Disorder
Communication Disorders
Neurodevelopmental Disorders
Mental Disorders