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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00418808
Other study ID # SHEBA-06-4067-OB-CTIL
Secondary ID
Status Recruiting
Phase Phase 1
First received January 4, 2007
Last updated January 22, 2007
Start date August 2006
Est. completion date August 2009

Study information

Verified date January 2007
Source Sheba Medical Center
Contact Omer Bar-Yosef, Dr.
Phone 972-3-5302896
Email omerbary@gmail.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

Cerebral Palsy (CP) is a major developmental problem. Major risk groups of CP, are preterm infants and multiple pregnancies. Previous studies using the General Movements methodology demonstrated early identification of CP, as early as 3 month of age. This method was implemented mainly on preterm infants this study goal is to enlarge the scope of the methodology to infants of multiple pregnancies. A second goal is to study early motor development and its future consequences by comparing the development of the infants of the same multiple pregnancy.


Description:

Cerebral Palsy (CP) is a motor development problem with a prevalence of 2 per 1000 live birth. There are many etiologies to the syndrome such as: brain malformations, infections during pregnancy, pre and perinatal, anoxic brain damage etc. A high risk group for these causes is preterm infants and infants of multiple pregnancies.

Major motor deficits or brain insults are recognizable at early weeks but most of them are more subtle and are recognized at the age of one to two years. The General Movements methodology was developed by Prechtl HF is aimed to identify motor development deficits as early as 3 month. The methodology is using video recording to describe a trajectory of the development of spontaneous movements between birth and 3 month. Deviation from the trajectory was highly correlated with future motor mal-development.

In our work we will study the motor development of infants of multiple pregnancies. These infants are one of the risk groups to develop CP. We will use the General movements methodology to identify CP as early as possible. It will generalize its predicative power to this risk group. Moreover, we will enlarge our knowledge of motor development by comparing the development of infants of the same pregnancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 4 Months
Eligibility Inclusion Criteria for preterm infants:

- preterm infant under 37 weeks

- Normal or intraventricular hemorrhage grade I at U/S examination

- No neurological family history

- No maternal drug use with neurological effect during pregnancy

- Normal prenatal history such as: no evidence of hypoxic ischemic encephalopathy

- No convulsions

- Normal karyotype

- No major congenital heart defect

- Dizygotic twins

Inclusion Criteria for full term infants:

- Normal physiological examination

- No neurological family history

- No maternal drug use with neurological effect during pregnancy

Study Design

Observational Model: Case Control, Primary Purpose: Screening, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Sheba medical center Tel - Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

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