Early Movements as a Predictor of Future Developmental Delay

Cerebral Palsy Clinical Trial

Official title:

Analysis of Movements of Singletons and Infants of Multiple Fetus Pregnancy as a Predictor of Developmental Delay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00418808
• Other study ID #: SHEBA-06-4067-OB-CTIL
• 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
• 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

• Cerebral Palsy
• Premature Birth

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,