Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates

This study has been terminated.
Sponsor:
Collaborators:
Children's Hospital Boston
Children's Mercy Hospital Kansas City
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00153855
First received: September 8, 2005
Last updated: September 6, 2006
Last verified: September 2006
  Purpose

The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants. It is hypothesized that this imaging will identify children with previously undiagnosed brain abnormalities and that the presence of structural abnormalities will be associated with deficits in motor, cognitive, and neurosensory development.


Condition Phase
Infant, Premature
Brain Injuries
Phase 3

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Estimated Enrollment: 50
Study Start Date: January 2005
Estimated Study Completion Date: March 2006
Detailed Description:

Infants born prematurely are at significant risk for hemorrhagic and ischemic brain injury. Despite improved survival rates among this population in recent years, these forms of brain injury remain frequent and have considerable consequences. Periventricular leukomalacia (PVL), a disease characterized by necrosis of the cerebral white matter in a characteristic distribution, is one of the most common types of brain injury seen in premature infants. MRI technology now allows for better anatomical resolution resulting in improvements in diagnostic accuracy. The current standard practice is not to perform routine MRI examinations on premature infants, nor is it routine to perform surveillance brain imaging in children after leaving the NICU. In their 2002 Practice Parameter for neuroimaging in the neonate, the American Academy of Neurology and the Practice Committee of the Child Neurology Society acknowledge the superiority of MRI in detection of brain lesions in premature infants, but fall short of recommending routine MRI scanning on the basis of a lack of information correlating MRI findings to neurodevelopmental outcomes. We now have a unique opportunity to help provide such information.

  Eligibility

Ages Eligible for Study:   24 Months to 27 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • must be participants in trial (NHLBI-UO1-HL62514-05A1 and FDA IND # 58,146 - Roberta A Ballard PI) of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants
  • gestational age between 24 months and 27 months

Exclusion Criteria:

  • history of allergy to sedation agents
  • medical conditions which may pose a threat to airway integrity (i.e., Pierre-Robin sequence, intercurrent respiratory illness)
  • other conditions which may otherwise place subjects at increased risk for complications from sedation and MRI examination
  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: NCT00153855

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital Boston
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Roberta A Ballard, M.D. Children's Hospital of Philadelphia
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00153855     History of Changes
Other Study ID Numbers: 2004-6-3818
Study First Received: September 8, 2005
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
etiology
pathology

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014