CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 target
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT00579943
NCT00579943N/ACompleted

Development of Cerebral Autoregulation in Very Low Birth Weight Infants

University of Arkansas·observational·Posted Dec 24, 2007·Updated Jun 4, 2008

In Brief

An observational study for Infant, Very Low Birth Weight and 2 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Advances in newborn intensive care have lead to dramatic improvements in survival for the most premature infants-often weighing 1 pound at birth. Unfortunately, cerebral palsy, mental retardation, and developmental delay affect more than 10,000 of these premature infants in the U.S. annually. In his studies, Dr. Jeffrey R. Kaiser is trying to understand why these premature infants are at such high risk of brain injury, and to learn ways to prevent injury. Experts believe that disturbances of brain blood flow regulation are important in causing these injuries. Using a novel continuous monitoring system, Dr. Kaiser is able to determine an infant's capacity for normal brain blood flow regulation. Contrary to previous thinking, he has shown that many of these babies in fact due have normal regulation of their brain blood flow. He has observed that brain blood flow may be disturbed during suctioning of the breathing tube. Further, he has also shown that infants with high carbon dioxide, those not breathing well, have impaired regulation of their brain blood flow. Thus, even stable infants are prone to disturbed brain regulation during routine intensive care, which may lead to bleeding in the brain and long-term neurologic problems. Dr. Kaiser will study up to 200 infants to determine 1) the developmental pattern of normal regulation of cerebral blood flow; 2) in those with impaired regulation, determine when it develops during the first week of life; and 3) determine the relationship between impaired brain blood flow regulation and brain injury. Results from this study will help us recognize when premature infants are most vulnerable to developing brain injury, allowing prevention and intervention strategies to be initiated in a timely fashion.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 24, 2007
Enrollment StartMay 1, 2001
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 18.5 years ago