Clinical trial NCT00418808: Early Movements as a Predictor of Future Developmental Delay
Official title: Analysis of Movements of Singletons and Infants of Multiple Fetus Pregnancy as a Predictor of Developmental Delay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Premature Birth
Keywords: motor
development
multiple pregnancies
general movement
video recording
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel - Hashomer
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Omer Bar-Yosef, Dr.
role: PRINCIPAL_INVESTIGATOR
References: