Sensory DeficitPretermNCT03172767
The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler
An observational study of Sensory Deficit and Preterm Birth, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness Read more about this study
- Who is it for?
- Ages 60 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- Sensory Deficit, Preterm Birth
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2017to 20 Jan 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 60 to 78 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm Preschoolers and Term Preschoolers
Who may be able to join
- No neurological diagnosis
- gestational age < 37 weeks
- 60-78 months of age
Who cannot join
- Have a neurological diagnosis (such as cerebral palsy)
- Grade III or grade IV intraventricular hemorrhage
- Have undergone major surgery in neonatal period
- Mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
The study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness
Read the detailed description
A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30 children. First, sociodemographic information and histories of children are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. . All examination wiil be finished in the same day.
- Conditions
- Sensory Deficit, Preterm Birth
- Keywords
- Preterm, Sensory processing, School Readiness
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Preschoolers | Preterm children who haven't attend school. | |
| Term Preschoolers | Term children who haven't attend school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marmara Primary School Readiness Scale
The application form includes math skills, science skills, voice exercises, line exercises and labyrinths; Development form; Mental-language development, socio-emotional development, physical development, self-care skills.
Measured: 45 minutes
Secondary outcomes (1)
Sensory profile caregiver questionnaire
The profile reveals the child's sensory appearance in terms of sensory search, emotional response formation, low endurance, oral tenderness, distractibility, weak perception, sensory sensitivity, activity level and fine motor / perceptual differences. In addition, the child evaluates the senses (sensory processing), adjustment (modulation), behavioral and emotional responses.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start20 Mar 2017
- Primary completion20 Sep 2017
- Study completion20 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensory DeficitStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
- Investigators
- Bülent Elbasan, Study chair, study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172767
- Sponsor's protocol ID
- 5461
- Acronym
- Preterm
- Status last verified
- May 2017
- First submitted
- 26 May 2017
- Last updated
- 12 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between School Readiness and Sensory Processing Disorder in Preterm Preschooler
- ClinicalTrials.gov ID
- NCT03172767
- Acronym / sponsor ID
- Preterm / 5461
- Conditions
- Sensory Deficit, Preterm Birth
- Keywords
- Preterm, Sensory processing, School Readiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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 study aims investigate sensory processing disorders and school readiness in pre-school preterm children and the relationship between sensory impairment and school readiness
Detailed description
A convenience of preterm and term preschoolers recruiting from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Each group contains 30 children. First, sociodemographic information and histories of children are obtaining. Ages and contact information of the parents are recording. Prenatal and natal risk factors of the mothers are querying. Gestational ages and height, weight, and head circumferences of babies at birth are recording. Number of pregnancies, live births and abortions, type of delivery, multiple pregnancies for mothers as well as consanguinity between parents are asking. Marmara Primary School Readiness Scale is using to evaluate mental-language development, socio-emotional development, physical development, self-care skills,math skills, science skills, voice exercises, line exercises and labyrinths. Sensory profile caregiver questionnaire screen for the senses (sensory processing), adjustment (modulation), behavioral and emotional responses. . All examination wiil be finished in the same day.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Preschoolers | – | –Preterm children who haven't attend school. |
| Term Preschoolers | – | –Term children who haven't attend school. |
Who may qualify
- Ages
- 60 to 78 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm Preschoolers and Term Preschoolers
Key inclusion criteria (3 listed)
- No neurological diagnosis
- gestational age < 37 weeks
- 60-78 months of age
Key exclusion criteria (4 listed)
- Have a neurological diagnosis (such as cerebral palsy)
- Grade III or grade IV intraventricular hemorrhage
- Have undergone major surgery in neonatal period
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Marmara Primary School Readiness Scale
Time frame: 45 minutes
The application form includes math skills, science skills, voice exercises, line exercises and labyrinths; Development form; Mental-language development, socio-emotional development, physical development, self-care skills.
1 secondary outcome
Sensory profile caregiver questionnaire
Time frame: 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Individual participant dataSharing planned: Yes
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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.
Bülent Elbasan study chair
study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sensory Deficit and Preterm Birth, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Apr 2018. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marmara Primary School Readiness Scale (time frame: 45 minutes). 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 Apr 2018.