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Early Intervention in Very Preterm Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Erasmus Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352481
First Posted: May 12, 2011
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Erasmus Medical Center
  Purpose
  • 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 Intervention
Prematurity Speech Sound Disorder Other: Early parent-based speech intervention program

Study Type: Interventional
Study Design: 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

Further study details as provided by Erasmus Medical Center:

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

Estimated Enrollment: 25
Study Start Date: April 2011
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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

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 Submitted: May 10, 2011
First Posted: May 12, 2011
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