<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682122</url>
  </required_header>
  <id_info>
    <org_study_id>SIUH12-037</org_study_id>
    <secondary_id>SIUH12-037</secondary_id>
    <nct_id>NCT01682122</nct_id>
  </id_info>
  <brief_title>Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population</brief_title>
  <official_title>Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Staten Island University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Staten Island University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This&#xD;
      study will evaluate the frequency and persistence of wide pulse pressure in the neonatal&#xD;
      population. Using a prospective study design in the Regular newborn and Observation nurseries&#xD;
      of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood&#xD;
      pressures measured using the oscillometric method. This data will offer insight into whether&#xD;
      the presence of wide pulse pressure in otherwise healthy newborn infants warrants further&#xD;
      cardiovascular evaluation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of wide pulse pressures in healthy newborn</measure>
    <time_frame>15 mins a day</time_frame>
    <description>This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">196</enrollment>
  <condition>Blood Pressure</condition>
  <condition>Pediatrics</condition>
  <condition>Infant, Newborn</condition>
  <condition>Cardiology</condition>
  <arm_group>
    <arm_group_label>Newborns</arm_group_label>
    <description>Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age. Infants with gestational age &gt; or = 35weeks and birth weight &gt; 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</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants with gestational age &gt; or = 35weeks and birth weight &gt; 2500g, who are&#xD;
             hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence&#xD;
             of sepsis. If a blood culture was drawn due to the presence of maternal risk factors&#xD;
             (e.g. maternal fever, prolonged rupture of membranes), patients will be included only&#xD;
             if the blood culture result is negative and in case of intrapartum antibiotic&#xD;
             treatment, ancillary blood tests (CBC with differential, CRP) are also within the&#xD;
             normal range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with gestational age &lt; 35weeks or birth weight &lt; 2500g and with evidence of&#xD;
             neonatal sepsis either culture proven or clinically suspected.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>72 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Philip Roth, MD, PhD</last_name>
    <phone>718-226-9360</phone>
    <email>Philip_Roth@siuh.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Omar Rodriguez, MD</last_name>
    <phone>7186793745</phone>
    <email>omarrodriguez.md@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Staten Island University Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305</zip>
        <country>United States</country>
      </address>
    </facility>
    <investigator>
      <last_name>Philip Roth, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Omar Rodriguez, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aditi Khokhar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siuh.edu</url>
    <description>institutional website</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Staten Island University Hospital</investigator_affiliation>
    <investigator_full_name>Philip Roth, MD, PhD</investigator_full_name>
    <investigator_title>Director of Neonatology Chairman, Dept. of Pediatrics, &amp; Vice President of Medical Education</investigator_title>
  </responsible_party>
  <keyword>Blood Pressure</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Infant, Newborn</keyword>
  <keyword>Cardiology</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682122
org study id: SIUH12-037
secondary id: SIUH12-037
nct id: NCT01682122
lead sponsor: 
has dmc: Yes
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
observational model: Cohort
time perspective: Prospective
measure: incidence of wide pulse pressures in healthy newborn
time frame: 15 mins a day
description: This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life.
arm group label: Newborns
description: 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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 72 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Philip Roth, MD, PhD
phone: 718-226-9360
email: Philip_Roth@siuh.edu
last name: Omar Rodriguez, MD
phone: 7186793745
email: omarrodriguez.md@gmail.com
facility: 
investigator: 
investigator: 
investigator: 
country: United States
url: http://www.siuh.edu
description: institutional website
responsible party type: Principal Investigator
investigator affiliation: Staten Island University Hospital
investigator full name: Philip Roth, MD, PhD
investigator title: Director of Neonatology Chairman, Dept. of Pediatrics, & Vice President of Medical Education