NCT01430845

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

4.3 years

First QC Date

September 7, 2011

Last Update Submit

June 28, 2018

Conditions

Keywords

GDDCPMRPDDASDBSID

Outcome Measures

Primary Outcomes (1)

  • level of Mental retardation in older age

    non

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • GDD diagnosis in two axis' at least
  • BSID test in its second or third version

You may not qualify if:

  • If not all of the data is available for all of the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Learning DisabilitiesCerebral PalsyIntellectual DisabilityChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Lidia Gabis, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
  • Shefer Shahar, PHD

    Sheba Medical Center

    STUDY DIRECTOR
  • Bat Chen Amir, BA

    Sheba Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 8, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 29, 2018

Record last verified: 2018-06

Locations