Study of Generalized Movements for Early Prediction of Cerebral Palsy

This study has been completed.
Sponsor:
Collaborator:
Hawaii Community Foundation
Information provided by (Responsible Party):
Charles R. Neal,, Hawaii Pacific Health
ClinicalTrials.gov Identifier:
NCT00749008
First received: September 8, 2008
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition
Cerebral Palsy
Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Prediction of Cerebral Palsy in Preterm Infants and Term Infants Using Detection of Generalized Movements

Resource links provided by NLM:


Further study details as provided by Hawaii Pacific Health:

Primary Outcome Measures:
  • Incidence of Cerebral Palsy [ Time Frame: Two Years of Age ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: September 2008
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Term Infants
High risk infants with history of respiratory insufficiency requiring NICU care.
Preterm Infants
Infants less than 37 weeks gestational age.

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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Congenital anomalies
  • Congenital heart disease
  • Any genetic anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749008

Locations
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Sponsors and Collaborators
Charles R. Neal,
Hawaii Community Foundation
Investigators
Principal Investigator: Charles R Neal, MD, PhD University of Hawaii John A. Burns School of Medicine
  More Information

No publications provided

Responsible Party: Charles R. Neal,, Principal Investigator, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT00749008     History of Changes
Other Study ID Numbers: RP#07-130-1-HPH1
Study First Received: September 8, 2008
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hawaii Pacific Health:
Cerebral palsy
Generalized movements
Fidgety movements
Prechtl

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014