Early Intervention in Very Preterm Children

NCT ID: NCT01352481

Last Updated: 2011-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Brief Summary

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* 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).

Detailed Description

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Conditions

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Prematurity Speech Sound Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Early parent-based speech intervention program

Intervention Type OTHER

Seven 1h sessions during a three-month period.

Control group

Group Type NO_INTERVENTION

Early parent-based speech intervention program

Intervention Type OTHER

Seven 1h sessions during a three-month period.

Interventions

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Early parent-based speech intervention program

Seven 1h sessions during a three-month period.

Intervention Type OTHER

Other Intervention Names

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Prematurity, Speech Sound Disorder, Early Intervention

Eligibility Criteria

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Inclusion Criteria

* birth weight \< 1500 grams or gestational age \< 32 weeks
* singleton birth
* no major neurodevelopmental disabilities, and
* Dutch speaking family background
Minimum Eligible Age

24 Months

Maximum Eligible Age

27 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Erasmus Medical University Center, Department of Otorhinolatyngology

Locations

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Erasmus Medical University Center

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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IL Van Noort-van der Spek

Role: CONTACT

MCJP Franken

Role: CONTACT

Facility Contacts

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van Noort-van der Spek

Role: primary

+31107036073

Other Identifiers

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NL33278.078.10

Identifier Type: -

Identifier Source: org_study_id

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