MedDataX Logo

Regulation of Cerebral Blood Flow in Very Low Birth Weight Infants

NCT ID: NCT00579943

Last Updated: 2008-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

premature infants

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Arkansas for Medical Sciences

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeffrey R. Kaiser, MD, MA

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 17473113 (View on PubMed)

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.

Reference Type RESULT
PMID: 16554847 (View on PubMed)

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.

Reference Type RESULT
PMID: 16257928 (View on PubMed)

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.

Reference Type RESULT
PMID: 15192631 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1K23NS043185

Identifier Type: NIH

Identifier Source: secondary_id

View Link

05594

Identifier Type: -

Identifier Source: org_study_id