Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

September 7, 2012 updated by: Philip Roth, MD, PhD, Staten Island University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
        • Principal Investigator:
          • Philip Roth, MD, PhD
        • Sub-Investigator:
          • Omar Rodriguez, MD
        • Sub-Investigator:
          • Aditi Khokhar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of wide pulse pressures in healthy newborn
Time Frame: 15 mins a day
This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life.
15 mins a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Staten Island University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (ESTIMATE)

September 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIUH12-037 (OTHER: Staten Island University Hospital - IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe