School ReadinessNCT03081624
Evaluation of Neurological Status and School Readiness in Preterm Preschoolers
An observational study of School Readiness, run by Gazi University.
Trial summary
Beginning school is an important milestone for children. Children's readiness for school involves cognitive, physical, and emotional development. While the majority of children born preterm are able to transition from preschool to kindergarten with little difficulty, some children experience challenges during this… Read more about this study
- Who is it for?
- Ages 60 to 78 monthsHealthy volunteers can take part
- Conditions the study is for
- School Readiness
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2016to 17 Jul 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 children and their age -matched term volunteers
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
About this study
Official title: Evaluation of Neurological Status and School Readiness of Preterm Children in Preschool Period
Beginning school is an important milestone for children. Children's readiness for school involves cognitive, physical, and emotional development. While the majority of children born preterm are able to transition from preschool to kindergarten with little difficulty, some children experience challenges during this time. Factors that negatively influence children's success in kindergarten include their age, socioeconomic status, neurological status and their ability to interpret sensory information from their environment.
This study was planned to explain the relationship between the primary school readiness and the neurological status of preterm born children.
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. The Touwen examination (neurological examination) is using to evaluate posture in various positions, muscle tone, dyskinesias, range of motion, reflexes, sensory function and cranial nerve function as well as developmental items, i.e. the items dealing with coordination, fine manipulative abilities and associated movements. All examination wiil be finished in the same day.
- Conditions
- School Readiness
- Keywords
- preterm, neurological status, 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 (2)
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
The Touwen examination (neurological examination)
The assesment includes traditional neurological items, such as the evaluation of posture in various positions, muscle tone, dyskinesias, range of motion, reflexes, sensory function and cranial nerve function as well as developmental items, i.e. the items dealing with coordination, fine manipulative abilities and associated movements.
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 posted16 Mar 2017
- Study start17 Dec 2016
- Primary completion17 Jul 2017 (estimated)
- Study completion17 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School ReadinessStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan Yildiz, Gazi University
- Investigators
- Bülent Elbasan, Phd, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081624
- Sponsor's protocol ID
- E.5461
- Status last verified
- Mar 2017
- First submitted
- 10 Mar 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Haven't decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurological Status and School Readiness of Preterm Children in Preschool Period
- ClinicalTrials.gov ID
- NCT03081624
- Acronym / sponsor ID
- E.5461
- Conditions
- School Readiness
- Keywords
- preterm, neurological status, School Readiness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 17 Dec 2016 (actual)
- Primary completion
- 17 Jul 2017 (estimated)
- Study completion
- 17 Jul 2018 (estimated)
- First posted
- 16 Mar 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.
Beginning school is an important milestone for children. Children's readiness for school involves cognitive, physical, and emotional development. While the majority of children born preterm are able to transition from preschool to kindergarten with little difficulty, some children experience challenges during this time. Factors that negatively influence children's success in kindergarten include their age, socioeconomic status, neurological status and their ability to interpret sensory information from their environment.
This study was planned to explain the relationship between the primary school readiness and the neurological status of preterm born children.
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. The Touwen examination (neurological examination) is using to evaluate posture in various positions, muscle tone, dyskinesias, range of motion, reflexes, sensory function and cranial nerve function as well as developmental items, i.e. the items dealing with coordination, fine manipulative abilities and associated movements. 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 children and their age -matched term volunteers
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.
2 secondary outcomes
Sensory profile caregiver questionnaire
Time frame: 45 minutes
The Touwen examination (neurological examination)
Time frame: 45 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: Undecided. Haven't decided yet.
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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, Phd study chair
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of School Readiness, run by Gazi University.
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: status not confirmed, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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 25 Apr 2017.