Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
1 other identifier
observational
196
1 country
1
Brief 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
Trial Health
Trial Health Score
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedSeptember 10, 2012
September 1, 2012
1 year
September 5, 2012
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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 Criteria
Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.
You may qualify if:
- 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
You may not qualify if:
- Infants with gestational age \< 35weeks or birth weight \< 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Staten Island University Hospital
Staten Island, New York, 10305, United States
Related Links
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neonatology Chairman, Dept. of Pediatrics, & Vice President of Medical Education
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 10, 2012
Study Start
August 1, 2012
Primary Completion
August 1, 2013
Last Updated
September 10, 2012
Record last verified: 2012-09