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NCT01682122 Clinical Trial

Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Blood Pressure Clinical Trial

Official title:
Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01682122
Other study ID # SIUH12-037
Secondary ID SIUH12-037
Status Not yet recruiting
Phase N/A
First received September 5, 2012
Last updated September 7, 2012
Start date August 2012

Study information
Verified date September 2012
Source Staten Island University Hospital
Contact Philip Roth, MD, PhD
Phone 718-226-9360
Email Philip_Roth@siuh.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This study will evaluate the frequency and persistence of wide pulse pressure in the neonatal population. Using a prospective study design in the Regular newborn and Observation nurseries of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood pressures measured using the oscillometric method. This data will offer insight into whether the presence of wide pulse pressure in otherwise healthy newborn infants warrants further cardiovascular evaluation

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 196
Est. completion date
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 72 Hours
Eligibility Inclusion Criteria:

- Infants with gestational age > or = 35weeks and birth weight > 2500g, who are hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence of sepsis. If a blood culture was drawn due to the presence of maternal risk factors (e.g. maternal fever, prolonged rupture of membranes), patients will be included only if the blood culture result is negative and in case of intrapartum antibiotic treatment, ancillary blood tests (CBC with differential, CRP) are also within the normal range

Exclusion Criteria:

- Infants with gestational age < 35weeks or birth weight < 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Staten Island University Hospital Staten Island New York

Sponsors (1)
Lead Sponsor Collaborator
Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of wide pulse pressures in healthy newborn This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life. 15 mins a day No
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