Ambulatory Blood Pressure Monitoring in Children

Summary

Ambulatory Blood Pressure Monitoring (ABPM) potentially offers a superior way to screen children for entry into antihypertensive trials, assuring that only those with true hypertension are enrolled.10 In addition, ABPM offers a better method to measure response to drug therapy.11-16 The ABPM device most commonly used in children (Spacelabs 90217 - Issaquah, Washington) has not been independently validated for use in this population. In 1993, the British Hypertension Society (BHS) published a protocol for validating ABPM devices, including guidance for validation studies in children.17 More recently, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension published revisions to these guidelines, but did not include children in this update.18 Unfortunately, the original BHS protocol suggests using a smaller group of children than the protocol outlines for adults. Since BP in children is more variable than in adults, this guidance is unlikely to be adequate for children. Hence, a large, stringent validation study needs to be conducted in a cohort of children using the methods similar to those used to validate the device in adults. Performance of the proposed validation study is needed to allow for the incorporation of ABPM into clinical trial designs of anti-hypertensives in children which will ultimately allow for more accurate identification of the hypertensive population and determination of response to therapy along with allowing for assessment of the chronobiologic profile of drug response over the dosing interval.9

Conditions

• Blood Pressure

Interventions

DEVICE

Spacelabs 90217

Comparison of the two ways to measure blood pressure: using the ambulatory blood pressure device (Spacelabs 90217) versus the standard method of measuring blood pressure is done by using a stethoscope and a blood pressure cuff.

Sponsors & Collaborators

• University of California, San Diego

  collaborator OTHER

• Arkansas Children's Hospital Research Institute

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  lead OTHER

Principal Investigators

• Jeffrey L. Blumer, Ph.D., M.D. · Universtiy Hosptials Case Medical Center

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2011-02-28

Completion

2011-02-28

Countries

• United States

Study Locations