Early Movements as a Predictor of Future Developmental Delay

NCT ID: NCT00418808

Last Updated: 2007-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2009-08-31

Brief 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.

Detailed 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.

Conditions

Cerebral Palsy; Premature Birth

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Normal physiological examination
• No neurological family history
• No maternal drug use with neurological effect during pregnancy

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Omer Bar-Yosef, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba medical center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Omer Bar-Yosef, Dr.

Role: CONTACT

omerbary@gmail.com

972-3-5302896

Facility Contacts

Omer Bar-Yosef, MD

Role: primary

Other Identifiers

SHEBA-06-4067-OB-CTIL

Identifier Type: -

Identifier Source: org_study_id