Study of Generalized Movements for Early Prediction of Cerebral Palsy

NCT00749008 | Completed DMC

• 1 other identifier: RP#07-130-1-HPH1
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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 predictive value of the investigators assessments based on the diagnosis of cerebral palsy.

Conditions

Cerebral Palsy; Prematurity

Keywords

Cerebral palsy; Generalized movements; Fidgety movements; Prechtl

Outcome Measures

Primary Outcomes (1)

• Incidence of Cerebral Palsy

  Two Years of Age

Study Arms (2)

Term Infants

High risk infants with history of respiratory insufficiency requiring NICU care.

Preterm Infants

Infants less than 37 weeks gestational age.

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Congenital anomalies
• Congenital heart disease
• Any genetic anomalies

Sponsors & Collaborators

• Charles R. Neal,: lead
• Hawaii Community Foundation: collaborator

Study Sites (1)

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Charles R Neal, MD, PhD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 25, 2014

Record last verified: 2014-02

Locations

US (1)