Early Intervention in Very Preterm Children
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01352481 |
Recruitment Status
: Unknown
Verified May 2011 by Erasmus Medical Center.
Recruitment status was: Recruiting
First Posted
: May 12, 2011
Last Update Posted
: May 12, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
- 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 or disease | Intervention/treatment | Phase |
---|---|---|
Prematurity Speech Sound Disorder | Other: Early parent-based speech intervention program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 25 participants |
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 |
Study Start Date : | April 2011 |
Estimated Primary Completion Date : | April 2013 |
Arm | Intervention/treatment |
---|---|
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
|
- Number of acquired consonants produced by the child [ Time Frame: 12 months after the onset of treatment ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 24 Months to 27 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- birth weight < 1500 grams or gestational age < 32 weeks
- singleton birth
- no major neurodevelopmental disabilities, and
- Dutch speaking family background

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
Contact: IL Van Noort-van der Spek | i.vanderspek@erasmusmc.nl | ||
Contact: MCJP Franken | m.franken@erasmusmc.nl |
Netherlands | |
Erasmus Medical University Center | Recruiting |
Rotterdam, Netherlands | |
Contact: van Noort-van der Spek +31107036073 | |
Principal Investigator: RJ Baatenburg de Jong |
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 Posted: | May 12, 2011 Key Record Dates |
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 |