PrematurityNCT01352481
Early Intervention in Very Preterm Children
A study testing Early parent-based speech intervention program in people with Prematurity and Speech Sound Disorder, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 27 months
- Conditions the study is for
- Prematurity, Speech Sound Disorder
- What is being tested?
- Early parent-based speech intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 27 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight < 1500 grams or gestational age < 32 weeks
- singleton birth
- no major neurodevelopmental disabilities, and
- Dutch speaking family background
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
IL Van Noort-van der Spek contact
MCJP Franken contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical University Center
Rotterdam
van Noort-van der Spek, +31107036073
RJ Baatenburg de Jong
About this study
Official title: 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).
- Conditions
- Prematurity, Speech Sound Disorder
- Being tested
- Early parent-based speech intervention program
- Keywords
- Speech sound development
- Medical subject headings
- Premature Birth, Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early parent-based speech intervention programOther
Also called Prematurity, Speech Sound Disorder, Early Intervention
Seven 1h sessions during a three-month period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Early parent-based speech intervention program |
| Control group | No intervention | Not described Receives: Other: Early parent-based speech intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acquired consonants produced by the child
Measured: 12 months after the onset of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352481
- Sponsor's protocol ID
- NL33278.078.10
- Status last verified
- May 2011
- First submitted
- 10 May 2011
- Last updated
- 12 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Speech Sound Disorder in Very Preterm Children
- ClinicalTrials.gov ID
- NCT01352481
- Acronym / sponsor ID
- NL33278.078.10
- Conditions
- Prematurity, Speech Sound Disorder
- Keywords
- Speech sound development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (estimated)
- First posted
- 12 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Early parent-based speech intervention program |
| Control group | No intervention | Other: Early parent-based speech intervention program |
Who may qualify
- Ages
- 24 to 27 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- birth weight < 1500 grams or gestational age < 32 weeks
- singleton birth
- no major neurodevelopmental disabilities, and
- Dutch speaking family background
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early parent-based speech intervention programAlso: Prematurity, Speech Sound Disorder, Early InterventionSeven 1h sessions during a three-month period. | Other | Control group, Intervention group |
Primary outcome
Number of acquired consonants produced by the child
Time frame: 12 months after the onset of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IL Van Noort-van der Spek contact
MCJP Franken contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early parent-based speech intervention program in people with Prematurity and Speech Sound Disorder, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IL Van Noort-van der Spek (i.vanderspek@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acquired consonants produced by the child (time frame: 12 months after the onset of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.