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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
May 10, 2011
May 12, 2011
May 12, 2011
April 2011
April 2013   (Final data collection date for primary outcome measure)
Number of acquired consonants produced by the child [ Time Frame: 12 months after the onset of treatment ]
Same as current
No Changes Posted
Not Provided
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Early Intervention in Very Preterm Children
Early Intervention for Speech Sound Disorder in Very Preterm Children
  • 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).
Not Provided
Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Prematurity
  • Speech Sound Disorder
Other: Early parent-based speech intervention program
Seven 1h sessions during a three-month period.
Other Name: Prematurity, Speech Sound Disorder, Early Intervention
  • Experimental: Intervention group
    Intervention: Other: Early parent-based speech intervention program
  • No Intervention: Control group
    Intervention: Other: Early parent-based speech intervention program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
25
Not Provided
April 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • birth weight < 1500 grams or gestational age < 32 weeks
  • singleton birth
  • no major neurodevelopmental disabilities, and
  • Dutch speaking family background
Sexes Eligible for Study: All
24 Months to 27 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01352481
NL33278.078.10
Not Provided
Not Provided
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RJ Baatenburg de Jong, MD, PhD, Head of Department, Erasmus Medical University Center, Department of Otorhinolatyngology
Erasmus Medical Center
Not Provided
Not Provided
Erasmus Medical Center
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP