Cerebral PalsyNCT00749008
Study of Generalized Movements for Early Prediction of Cerebral Palsy
An observational study of Cerebral Palsy and Prematurity, run by Charles R. Neal, at 1 site in United States.
Trial summary
The purpose of this study is to assess the predictive value of generalized movements in preterm and term infants who are at risk for development of cerebral palsy. The investigators will identify at-risk infants and observe their generalized movements, conduct a two year longitudinal follow-up, and interpret the… Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Prematurity
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Feb 2014
- 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 Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm and term infants in the state of Hawaii, with and without lung disease, who are at risk for development of cerebral palsy.
Who may be able to join
- Term newborns with pulmonary diseases (meconium aspiration, congenital diaphragmatic hernia, bronchopulmonary dysplasia, pneumonia, lobar emphysema and respiratory distress syndrome)
- Preterm infants less than 30 weeks of gestational age or less than 1500g weight
- Preterm or term infants with intrauterine growth retardation
- Infants with the diagnosis of IVH larger than grade II
- Infants diagnosed with periventricular leukomalacia
- Any preterm and term infant who experienced hypoxic-ischemic injury, defined as having a 5 minute Apgar score less than 4 or requiring resuscitation >10 minutes.
Who cannot join
- Congenital anomalies
- Congenital heart disease
- Any genetic anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
About this study
Official title: Early Prediction of Cerebral Palsy in Preterm Infants and Term Infants Using Detection of Generalized Movements
The purpose of this study is to assess the predictive value of generalized movements in preterm and term infants who are at risk for development of cerebral palsy. The investigators will identify at-risk infants and observe their generalized movements, conduct a two year longitudinal follow-up, and interpret the predictive value of the investigators assessments based on the diagnosis of cerebral palsy.
Read the detailed description
Cerebral palsy (CP) is considered a clinical syndrome caused by a preceding brain injury early in brain development that results in static neurological deficits. These deficits usually involve the somatomotor system manifesting as hemi-, di- or quadriplegia. Cerebral palsy can also manifest as hypertonicity and contractures, sensory deficits, hearing and visual difficulties, feeding problems and global developmental delay and almost always coincides with chronic lung disease. The most common causes of cerebral palsy are hypoxic-ischemic brain injury, periventricular leukomalacia or intraventricular and/or parenchymal hemorrhage that occurs in the first year of life. Hypoxic brain injury as a result of poor oxygen delivery often occurs in the perinatal period but can also be caused by pulmonary dysfunction. Thus, pulmonary diseases such as bronchopulmonary dysplasia, pneumonia, meconium aspiration syndrome, congenital diaphragmatic hernia and respiratory distress syndrome can lead to hypoxic brain injury and consequent CP. Less common etiologies are genetic disorders, infections and intrapartum injuries. Current treatments of CP are targeted to maintaining function, relieving contractures, improving nutrition and providing developmental supportive care, but to date there is no cure or preventive guideline. Moreover, supportive measures and family counseling is delayed since CP can be diagnosed only at the age of 18-24 months. As a result, interventions that may aid in limiting CP effects are delayed due to the lack of a predictive diagnostic assessment during the first six months of life. Head ultrasound, EEG and functional MRI have been tested for their predictive value before the actual diagnosis of cerebral palsy. The low sensitivity of these studies shows that they are not useful as screening tools. Heinz Prechtl, an Austrian neurologist, developed a clinical assessment method to study the spontaneous movements of preterm and term infants. Monitoring of cramped synchronized generalized movements and fidgety movements has resulted in 100% sensitivity and 95% specificity in predicting cerebral palsy in many studies. A meta-analysis of predictive tools for cerebral palsy identified Prechtl's method as superior to head ultrasound or MRI. These studies have not been repeated in the USA. Our aim is to assess the predictive value of Prechtl's method in Hawaii, in preterm and term infants with and without lung disease, who are at risk for development of cerebral palsy. We will compare the incidence of pulmonary diseases and cerebral palsy and observe any relationship between the development of lung disease and brain injury. We will identify at risk infants and observe their generalized movements according to Prechtl's assessment. We will conduct a 2-year longitudinal follow up of our patients and interpret the predictive value of our assessment based on the diagnosis of cerebral palsy. We will compare the sensitivity and positive predictive value of head ultrasound and the assessment of generalized movements. It is hoped that this assessment will allow us to start supportive measures at an earlier stage of life, thus improving the outcome of children with cerebral palsy.
- Conditions
- Cerebral Palsy, Prematurity
- Keywords
- Cerebral palsy, Generalized movements, Fidgety movements, Prechtl
- Medical subject headings
- Cerebral Palsy, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Term Infants | High risk infants with history of respiratory insufficiency requiring NICU care. | |
| Preterm Infants | Infants less than 37 weeks gestational age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cerebral Palsy
Measured: Two Years of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles R. Neal,
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaii Community Foundation
- Responsible party
- Sponsor-investigator, Charles R. Neal,, Hawaii Pacific Health
- Investigators
- Charles R Neal, MD, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749008
- Sponsor's protocol ID
- RP#07-130-1-HPH1
- Status last verified
- Feb 2014
- First submitted
- 8 Sep 2008
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Cerebral Palsy in Preterm Infants and Term Infants Using Detection of Generalized Movements
- ClinicalTrials.gov ID
- NCT00749008
- Acronym / sponsor ID
- RP#07-130-1-HPH1
- Conditions
- Cerebral Palsy, Prematurity
- Keywords
- Cerebral palsy, Generalized movements, Fidgety movements, Prechtl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Charles R. Neal,University, hospital or other
- Collaborators
- Hawaii Community Foundation
- Study start
- Sep 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Sep 2008 (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.
The purpose of this study is to assess the predictive value of generalized movements in preterm and term infants who are at risk for development of cerebral palsy. The investigators will identify at-risk infants and observe their generalized movements, conduct a two year longitudinal follow-up, and interpret the predictive value of the investigators assessments based on the diagnosis of cerebral palsy.
Detailed description
Cerebral palsy (CP) is considered a clinical syndrome caused by a preceding brain injury early in brain development that results in static neurological deficits. These deficits usually involve the somatomotor system manifesting as hemi-, di- or quadriplegia. Cerebral palsy can also manifest as hypertonicity and contractures, sensory deficits, hearing and visual difficulties, feeding problems and global developmental delay and almost always coincides with chronic lung disease. The most common causes of cerebral palsy are hypoxic-ischemic brain injury, periventricular leukomalacia or intraventricular and/or parenchymal hemorrhage that occurs in the first year of life. Hypoxic brain injury as a result of poor oxygen delivery often occurs in the perinatal period but can also be caused by pulmonary dysfunction. Thus, pulmonary diseases such as bronchopulmonary dysplasia, pneumonia, meconium aspiration syndrome, congenital diaphragmatic hernia and respiratory distress syndrome can lead to hypoxic brain injury and consequent CP. Less common etiologies are genetic disorders, infections and intrapartum injuries. Current treatments of CP are targeted to maintaining function, relieving contractures, improving nutrition and providing developmental supportive care, but to date there is no cure or preventive guideline. Moreover, supportive measures and family counseling is delayed since CP can be diagnosed only at the age of 18-24 months. As a result, interventions that may aid in limiting CP effects are delayed due to the lack of a predictive diagnostic assessment during the first six months of life. Head ultrasound, EEG and functional MRI have been tested for their predictive value before the actual diagnosis of cerebral palsy. The low sensitivity of these studies shows that they are not useful as screening tools. Heinz Prechtl, an Austrian neurologist, developed a clinical assessment method to study the spontaneous movements of preterm and term infants. Monitoring of cramped synchronized generalized movements and fidgety movements has resulted in 100% sensitivity and 95% specificity in predicting cerebral palsy in many studies. A meta-analysis of predictive tools for cerebral palsy identified Prechtl's method as superior to head ultrasound or MRI. These studies have not been repeated in the USA. Our aim is to assess the predictive value of Prechtl's method in Hawaii, in preterm and term infants with and without lung disease, who are at risk for development of cerebral palsy. We will compare the incidence of pulmonary diseases and cerebral palsy and observe any relationship between the development of lung disease and brain injury. We will identify at risk infants and observe their generalized movements according to Prechtl's assessment. We will conduct a 2-year longitudinal follow up of our patients and interpret the predictive value of our assessment based on the diagnosis of cerebral palsy. We will compare the sensitivity and positive predictive value of head ultrasound and the assessment of generalized movements. It is hoped that this assessment will allow us to start supportive measures at an earlier stage of life, thus improving the outcome of children with cerebral palsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term Infants | – | –High risk infants with history of respiratory insufficiency requiring NICU care. |
| Preterm Infants | – | –Infants less than 37 weeks gestational age. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm and term infants in the state of Hawaii, with and without lung disease, who are at risk for development of cerebral palsy.
Key inclusion criteria (6 listed)
- Term newborns with pulmonary diseases (meconium aspiration, congenital diaphragmatic hernia, bronchopulmonary dysplasia, pneumonia, lobar emphysema and respiratory distress syndrome)
- Preterm infants less than 30 weeks of gestational age or less than 1500g weight
- Preterm or term infants with intrauterine growth retardation
- Infants with the diagnosis of IVH larger than grade II
- Infants diagnosed with periventricular leukomalacia
Key exclusion criteria (3 listed)
- Congenital anomalies
- Congenital heart disease
- Any genetic anomalies
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
Incidence of Cerebral Palsy
Time frame: Two Years of Age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
Charles R Neal, MD, PhD principal investigator
University of Hawaii
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 Prematurity, run by Charles R. Neal, at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 25 Feb 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Cerebral Palsy (time frame: Two Years of Age). It is what the study was designed to measure, not a finding.
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 25 Feb 2014.