Early Intervention in Very Preterm Children

May 11, 2011 updated by: Erasmus Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical University Center
        • Contact:
          • van Noort-van der Spek
          • Phone Number: +31107036073
        • Principal Investigator:
          • RJ Baatenburg de Jong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • birth weight < 1500 grams or gestational age < 32 weeks
  • singleton birth
  • no major neurodevelopmental disabilities, and
  • Dutch speaking family background

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Other: Early parent-based speech intervention program
Seven 1h sessions during a three-month period.
Other Names:
  • Prematurity, Speech Sound Disorder, Early Intervention
EXPERIMENTAL: Intervention group
Other: Early parent-based speech intervention program
Seven 1h sessions during a three-month period.
Other Names:
  • Prematurity, Speech Sound Disorder, Early Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of acquired consonants produced by the child
Time Frame: 12 months after the onset of treatment
12 months after the onset of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

April 1, 2013

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (ESTIMATE)

May 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL33278.078.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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