Global Developmental DelayNCT01430845
Predicting Developmental Disability Type and Mental Retardation Level in Children With General Developmental Delay
An observational study of Global Developmental Delay and Cerebral Palsy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Global Developmental Delay, Cerebral Palsy, Mental Retardation
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2011to 1 Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted at the Child Development Center in Tel-Hashomer hospital (Ramat-Gan, Israel). The target population is all children who were diagnosed at the hospital with GDD (in two axis' at least) between the years 2003 to 2005. They must also have undergone the BSID test in its second or third version. The data must be available on all assessments (N~150). The children were 1.5-3 years old at diagnosis and diagnosed by a doctor and psychologist. Today these children are 5-7 years old. Some of them are still being treated in Tel-Hashomer. The children live all over the country
Who may be able to join
- GDD diagnosis in two axis' at least
- BSID test in its second or third version
Who cannot join
- If not all of the data is available for all of the assessments
Trial locations and contacts
1 site in 1 country.
Israel1 site
Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Ramat Gan
About this study
Official title: Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay
The purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).
Read the detailed description
The purpose of this study is to find the relationship between the stage and quality of developmental delay at a young age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders). We assume that analysis of developmental subtests can show the developmental direction of the child and predict his later diagnosis. The developmental test which is chosen for this purpose is the BSID which is a comprehensive and worldwide developmental test. In addition, we want to find the correlation between the developmental delays in early age and the intellectual functioning in the future. We assume that through analyzing the subtests of developmental tests we will succeed in predicting the expected cognitive level (IQ).
Medical files of participating children will be analyzed. The files will be sorted and only those of GDD diagnosis containing BSID test data will be selected. The performances of the BSID test and the current diagnosis of the children will be recorded. A trained researcher will process the BSID data and build a database which will include the findings of the test, the current diagnosis of the child and the level of MR, in case the child suffers from MR (only or comorbidly). In order to test the research assumptions appropriate statistic tests will be done using the statistical program SPSS version 17.
This study has important implications. Findings which show that the developmental tests are effective tools, not only to evaluate general developmental delay, but as auxiliary tools for diagnosing and predicting the type of disability and level of retardation. These findings are a breakthrough in the diagnostic field. In addition, the ability to predict the type of disability and level of mental retardation by a developmental test that is used so widely allows early intervention, and as has been widely proven, the earlier the intervention, the better the outcome.
In addition, a vast range of people will benefit from the findings. Professionals such as doctors, psychologists and paramedical therapists, government bodies and community resources that can design and build a support system and services for the child and his family. Most importantly, the family of the diagnosed child and the child himself will be able to prepare themselves to the new reality and design their life accordingly.
- Conditions
- Global Developmental Delay, Cerebral Palsy, Mental Retardation, Pervasive Developmental Disorders
- Keywords
- GDD, CP, MR, PDD, ASD, BSID
- Medical subject headings
- Learning Disabilities, Cerebral Palsy, Intellectual Disability, Child Development Disorders, Pervasive
What is being measured
The primary outcome is the main question the study is designed to answer.
level of Mental retardation in older age
Measured: non
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Global Developmental DelayStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lidia Gabis, MD, Principal investigator, Sheba Medical CenterShefer Shahar, PHD, Study director, Sheba Medical CenterBat Chen Amir, BA, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430845
- Sponsor's protocol ID
- SHEBA-11-8458-LG-CTIL
- Status last verified
- Jun 2018
- First submitted
- 7 Sep 2011
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Developmental Disability Type and Mental Retardation Level in Children Who Were Diagnosed in General Developmental Delay
- ClinicalTrials.gov ID
- NCT01430845
- Acronym / sponsor ID
- SHEBA-11-8458-LG-CTIL
- Conditions
- Global Developmental Delay, Cerebral Palsy, Mental Retardation, Pervasive Developmental Disorders
- Keywords
- GDD, CP, MR, PDD, ASD, BSID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Sep 2011
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 8 Sep 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 purpose of this study is to find the relationship between the stage and quality of developmental delay during infancy and toddler age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders).
Detailed description
The purpose of this study is to find the relationship between the stage and quality of developmental delay at a young age, and the final diagnosis that the child gets a few years later (MR, type of PDD, CP or comorbidity of a few disorders). We assume that analysis of developmental subtests can show the developmental direction of the child and predict his later diagnosis. The developmental test which is chosen for this purpose is the BSID which is a comprehensive and worldwide developmental test. In addition, we want to find the correlation between the developmental delays in early age and the intellectual functioning in the future. We assume that through analyzing the subtests of developmental tests we will succeed in predicting the expected cognitive level (IQ).
Medical files of participating children will be analyzed. The files will be sorted and only those of GDD diagnosis containing BSID test data will be selected. The performances of the BSID test and the current diagnosis of the children will be recorded. A trained researcher will process the BSID data and build a database which will include the findings of the test, the current diagnosis of the child and the level of MR, in case the child suffers from MR (only or comorbidly). In order to test the research assumptions appropriate statistic tests will be done using the statistical program SPSS version 17.
This study has important implications. Findings which show that the developmental tests are effective tools, not only to evaluate general developmental delay, but as auxiliary tools for diagnosing and predicting the type of disability and level of retardation. These findings are a breakthrough in the diagnostic field. In addition, the ability to predict the type of disability and level of mental retardation by a developmental test that is used so widely allows early intervention, and as has been widely proven, the earlier the intervention, the better the outcome.
In addition, a vast range of people will benefit from the findings. Professionals such as doctors, psychologists and paramedical therapists, government bodies and community resources that can design and build a support system and services for the child and his family. Most importantly, the family of the diagnosed child and the child himself will be able to prepare themselves to the new reality and design their life accordingly.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted at the Child Development Center in Tel-Hashomer hospital (Ramat-Gan, Israel). The target population is all children who were diagnosed at the hospital with GDD (in two axis' at least) between the years 2003 to 2005. They must also have undergone the BSID test in its second or third version. The data must be available on all assessments (N~150). The children were 1.5-3 years old at diagnosis and diagnosed by a doctor and psychologist. Today these children are 5-7 years old. Some of them are still being treated in Tel-Hashomer. The children live all over the country
Key inclusion criteria (2 listed)
- GDD diagnosis in two axis' at least
- BSID test in its second or third version
Key exclusion criteria (1 listed)
- If not all of the data is available for all of the assessments
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
level of Mental retardation in older age
Time frame: non
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 29 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Global Developmental Delay
Not yet recruiting
Efficacy of a Video-based, Parent-centered Home Developmental Intervention for Infants at High Risk for Developmental Delay: a Multicenter Randomized Controlled Trial
Preterm
RecruitingObservational study
FOXP1 Syndrome: The Seaver Autism Center for Research and Treatment is Characterizing FOXP1-related Neurodevelopmental Disorders Using Genetic, Medical, and Neuropsychological Measures.
FOXP1, Mental Retardation With Language Impairment and With or Without Autistic Features
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
Enrolling by invitation
Exploratory Trial of a Pediatric Web-Based Care Planning Guide
Developmental Disabilities, Developmental Delay
RecruitingObservational study
The Neurodevelopmental and Behavioral Phenotyping Screening Protocol
Neurologic Disorders, Autism
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.
Lidia Gabis, MD principal investigator
Sheba Medical Center
Shefer Shahar, PHD study director
Sheba Medical Center
Bat Chen Amir, BA study director
Sheba Medical Center
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 Global Developmental Delay and Cerebral Palsy, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 1 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 29 Jun 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 Israel. 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?
level of Mental retardation in older age (time frame: non). 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 29 Jun 2018.