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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT00749008
Study groupRoleWhat they receive
Term InfantsHigh risk infants with history of respiratory insufficiency requiring NICU care.
Preterm InfantsInfants less than 37 weeks gestational age.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted9 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

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)
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

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.

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