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. 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

• Blood Pressure
• Cardiology
• Infant, Newborn
• Pediatrics

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

External Links

•   institutional website