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Early Movements as a Predictor of Future Developmental Delay

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00418808
First received: January 4, 2007
Last updated: January 22, 2007
Last verified: January 2007
History of Changes
  Purpose

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.


Condition Phase
Cerebral Palsy
Premature Birth
 Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective
Official Title: Analysis of Movements of Singletons and Infants of Multiple Fetus Pregnancy as a Predictor of Developmental Delay

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: August 2009
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.

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00418808

Contacts
Contact: Omer Bar-Yosef, Dr. 972-3-5302896 omerbary@gmail.com

Locations
Israel
Sheba medical center Recruiting
Tel - Hashomer, Israel, 52621
Contact: Omer Bar-Yosef, MD            
Principal Investigator: Omer Bar-Yosef, Dr.            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Omer Bar-Yosef, Dr. Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418808     History of Changes
Other Study ID Numbers: SHEBA-06-4067-OB-CTIL
Study First Received: January 4, 2007
Last Updated: January 22, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
motor
development
multiple pregnancies
general movement
video recording

Additional relevant MeSH terms:
Cerebral Palsy
Premature Birth
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 19, 2013