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Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

NCT ID: NCT01682122

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Blood Pressure Pediatrics Infant, Newborn Cardiology

Keywords

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Blood Pressure Pediatrics Infant, Newborn Cardiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Staten Island University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Philip Roth, MD, PhD

Director of Neonatology Chairman, Dept. of Pediatrics, & Vice President of Medical Education

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

Central Contacts

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Philip Roth, MD, PhD

Role: CONTACT

Phone: 718-226-9360

Email: [email protected]

Omar Rodriguez, MD

Role: CONTACT

Phone: 7186793745

Email: [email protected]

Related Links

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http://www.siuh.edu

institutional website

Other Identifiers

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SIUH12-037

Identifier Type: OTHER

Identifier Source: secondary_id

SIUH12-037

Identifier Type: -

Identifier Source: org_study_id