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Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

This study is not yet open for participant recruitment.
Verified September 2012 by Staten Island University Hospital
Sponsor:
Information provided by (Responsible Party):
Philip Roth, MD, PhD, Staten Island University Hospital
ClinicalTrials.gov Identifier:
NCT01682122
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition
Blood Pressure
Pediatrics
Infant, Newborn
Cardiology

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Further study details as provided by Staten Island University Hospital:

Primary Outcome Measures:
  • incidence of wide pulse pressures in healthy newborn [ Time Frame: 15 mins a day ] [ Designated as safety issue: No ]
    This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life.


Estimated Enrollment: 196
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newborns
Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age. 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

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01682122

Contacts
Contact: Philip Roth, MD, PhD 718-226-9360 Philip_Roth@siuh.edu
Contact: Omar Rodriguez, MD 7186793745 omarrodriguez.md@gmail.com

Locations
United States, New York
Staten Island University Hospital Not yet recruiting
Staten Island, New York, United States, 10305
Principal Investigator: Philip Roth, MD, PhD            
Sub-Investigator: Omar Rodriguez, MD            
Sub-Investigator: Aditi Khokhar, MD            
Sponsors and Collaborators
Staten Island University Hospital
  More Information

Additional Information:
institutional website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Philip Roth, MD, PhD, Director of Neonatology Chairman, Dept. of Pediatrics, & Vice President of Medical Education, Staten Island University Hospital
ClinicalTrials.gov Identifier: NCT01682122     History of Changes
Other Study ID Numbers: SIUH12-037, SIUH12-037
Study First Received: September 5, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Staten Island University Hospital:
Blood Pressure
Pediatrics
Infant, Newborn
Cardiology

ClinicalTrials.gov processed this record on May 23, 2013