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
  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 Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Intervention for Speech Sound Disorder in Very Preterm Children

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   24 Months to 27 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 10, 2011
Last Updated: May 11, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
Speech sound development

Additional relevant MeSH terms:
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014