Cerebral PalsyNCT00418808
Early Movements as a Predictor of Future Developmental Delay
An observational study of Cerebral Palsy and Premature Birth, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 2 days to 4 months
- Conditions the study is for
- Cerebral Palsy, Premature Birth
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2006to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Tel HaShomer, 52621
Omer Bar-Yosef, MD
Omer Bar-Yosef, Dr.
About this study
Official title: Analysis of Movements of Singletons and Infants of Multiple Fetus Pregnancy as a Predictor of Developmental Delay
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.
Read the 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
- Keywords
- motor, development, multiple pregnancies, general movement, video recording
- Medical subject headings
- Cerebral Palsy, Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startAug 2006
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Omer Bar-Yosef, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418808
- Sponsor's protocol ID
- SHEBA-06-4067-OB-CTIL
- Status last verified
- Jan 2007
- First submitted
- 4 Jan 2007
- Last updated
- 23 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Movements of Singletons and Infants of Multiple Fetus Pregnancy as a Predictor of Developmental Delay
- ClinicalTrials.gov ID
- NCT00418808
- Acronym / sponsor ID
- SHEBA-06-4067-OB-CTIL
- Conditions
- Cerebral Palsy, Premature Birth
- Keywords
- motor, development, multiple pregnancies, general movement, video recording
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2006
- Study completion
- Aug 2009
- First posted
- 5 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 2 days to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Bar-Yosef, Dr. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Premature Birth, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omer Bar-Yosef, Dr. (972-3-5302896, omerbary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2007.