Early Intervention in Very Preterm Children | NCT01352481

Studies
Early Intervention in Very Preterm Children

NCT01352481

Sponsor

Erasmus Medical Center

Status

Unknown status

Last Update Posted

May 12, 2011Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Prematurity
Speech Sound Disorder

Interventions

Early parent-based speech intervention program

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Apr 2013Estimated

Completion Date

Not provided

First Submitted Date

May 10, 2011

First Submission Date that Met QC Criteria

May 11, 2011

First Posted Date

May 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2011

Last Update Posted Date

May 12, 2011Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental		Other: Early parent-based speech intervention program
Control group	No Intervention		Other: Early parent-based speech intervention program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early parent-based speech intervention program	Other	Seven 1h sessions during a three-month period.	Control group Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Months

Maximum Age

27 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
IL Van Noort-van der Spek	Contact			i.vanderspek@erasmusmc.nl
MCJP Franken	Contact			m.franken@erasmusmc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmus Medical University Center	Recruiting	Rotterdam			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D066229	Speech Sound Disorder

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012837	Silver Sulfadiazine
D018479	Early Intervention, Educational

Ancestor Terms

ID	Term
D013411	Sulfadiazine
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides

Browse Leaves

Not provided

Browse Branches

Not provided