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Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants

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ClinicalTrials.gov Identifier: NCT00579943
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : June 4, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease
Infant, Very Low Birth Weight Infant, Premature, Diseases Cerebral Hemorrhage

Detailed Description:
This proposal outlines a program to study the development of cerebral autoregulation in very low birth weight (VLBW) (less than 1500 grams birth weight) infants, and its role in brain injury. Despite improvements in intensive care, brain injury in VLBW infants remains a significant health problem. This is due to the increasing incidence of prematurity and increasing survival rates of those VLBW infants most prone to developing intraventricular hemorrhage. Overwhelming evidence suggests that disturbances of autoregulation are important in the pathogenesis of these injuries. Autoregulation is a mechanism that maintains constant blood flow to the brain despite wide variations in blood pressure. However, because previous studies have pooled data from infants with different gestational and postnatal ages, little is known about how autoregulation develops in VLBW infants. A novel monitoring system will be used to test the central hypotheses that cerebral autoregulatory capacity in VLBW infants is developmentally acquired and that its disruption is associated with brain injury. The ontogenetic profile of autoregulatory capacity in VLBW infants will be determined. In those who lack autoregulation, the postnatal time course for development will be assessed. Then the relationship between the absence of autoregulation and brain injury will be established. Two hundred VLBW infants who have normal findings on a cranial ultrasound on day of life 1 will be enrolled. Continuous 1-hour measurements of cerebral blood flow velocity (transcranial Doppler ultrasound) will be compared to simultaneous measurements of blood pressure using multivariate analysis, after adjusting for variations in arterial blood gases (continuous blood gas monitor), to determine autoregulatory capacity (twice daily during the first 3 days of life and once on days 4-7). Results will be analyzed for each individual and for gestational age groups (23-25, 26-28, and greater than 29 weeks'). Results from this study will help us recognize when VLBW infants are most vulnerable to developing brain injury, allowing prevention and intervention strategies to be initiated in a timely fashion. Dr. Jeffrey Kaiser will take advantage of the strong mentoring, protected research time and outstanding academic resources of the University of Arkansas for Medical Sciences to reach his goal of becoming an independent investigator.

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Cerebral Autoregulation in Very Low Birth Weight Infants
Study Start Date : May 2001
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

premature infants
Inpatient very low birth weight infants who are ventilated and have an umbilical arterial catheter in place

Outcome Measures

Primary Outcome Measures :
  1. Determine when a premature infant develops the capacity for intact cerebral autoregulation [ Time Frame: First week of life ]

Secondary Outcome Measures :
  1. Determine how hypercapnia affects the capacity for intact autoregulation [ Time Frame: First week of life ]
  2. Determine if impaired autoregulation is associated with brain injury [ Time Frame: First week of life ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonatal Intensive Care Unit

Inclusion Criteria:

  • Very low birth weight infants, ventilated, umbilical arterial catheter in place

Exclusion Criteria:

  • Infants with serious congenital anomalies and chromosomal abnormalities
  • Infants not intubated
  • Infants without umbilical arterial catheter
  • Infants without parental consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579943

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Jeffrey R. Kaiser, MD, MA University of Arkansas
More Information

Responsible Party: Jeffrey R. Kaiser, MD, MA Associate Professor, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00579943     History of Changes
Other Study ID Numbers: 05594
1K23NS043185 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008

Keywords provided by University of Arkansas:
very low birth weight infant
cerebral autoregulation
intraventricular hemorrhage
carbon dioxide
cerebral blood flow velocity
ultrasonography, Doppler, transcranial
cerebrovascular circulation

Additional relevant MeSH terms:
Body Weight
Birth Weight
Cerebral Hemorrhage
Infant, Premature, Diseases
Signs and Symptoms
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Infant, Newborn, Diseases