Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants

NCT00579943 | Completed

• 2 other identifiers: 055941K23NS043185
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Very Low Birth Weight; Infant, Premature, Diseases; Cerebral Hemorrhage

Keywords

very low birth weight infant; cerebral autoregulation; intraventricular hemorrhage; carbon dioxide; cerebral blood flow velocity; ultrasonography, Doppler, transcranial; cerebrovascular circulation

Outcome Measures

Primary Outcomes (1)

• Determine when a premature infant develops the capacity for intact cerebral autoregulation

  First week of life

Secondary Outcomes (2)

• Determine how hypercapnia affects the capacity for intact autoregulation

  First week of life

• Determine if impaired autoregulation is associated with brain injury

  First week of life

Study Arms (1)

premature infants

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

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal Intensive Care Unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (4)

• Kaiser JR. Both extremes of arterial carbon dioxide pressure and the magnitude of fluctuations in arterial carbon dioxide pressure are associated with severe intraventricular hemorrhage in preterm infants. Pediatrics. 2007 May;119(5):1039; author reply 1039-40. doi: 10.1542/peds.2007-0353. No abstract available.

  PMID: 17473113 RESULT

• Kaiser JR, Gauss CH, Pont MM, Williams DK. Hypercapnia during the first 3 days of life is associated with severe intraventricular hemorrhage in very low birth weight infants. J Perinatol. 2006 May;26(5):279-85. doi: 10.1038/sj.jp.7211492.

  PMID: 16554847 RESULT

• Kaiser JR, Gauss CH, Williams DK. The effects of hypercapnia on cerebral autoregulation in ventilated very low birth weight infants. Pediatr Res. 2005 Nov;58(5):931-5. doi: 10.1203/01.pdr.0000182180.80645.0c.

  PMID: 16257928 RESULT

• Kaiser JR, Gauss CH, Williams DK. Surfactant administration acutely affects cerebral and systemic hemodynamics and gas exchange in very-low-birth-weight infants. J Pediatr. 2004 Jun;144(6):809-14. doi: 10.1016/j.jpeds.2004.03.022.

  PMID: 15192631 RESULT

MeSH Terms

Conditions

Infant, Premature, Diseases; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey R. Kaiser, MD, MA

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: May 1, 2001
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

US (1)