Early Intervention in Very Preterm Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01352481
First received: May 10, 2011
Last updated: May 11, 2011
Last verified: May 2011

May 10, 2011
May 11, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01352481 on ClinicalTrials.gov Archive Site
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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).
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
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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
Both
24 Months to 27 Months
No
Contact: IL Van Noort-van der Spek i.vanderspek@erasmusmc.nl
Contact: MCJP Franken m.franken@erasmusmc.nl
Netherlands
 
NCT01352481
NL33278.078.10
Not Provided
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