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Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Philip Roth, MD, PhD, Staten Island University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01682122
First Posted: September 10, 2012
Last Update Posted: September 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philip Roth, MD, PhD, Staten Island University Hospital
September 5, 2012
September 10, 2012
September 10, 2012
August 2012
August 2013   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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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
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.
  • Blood Pressure
  • Pediatrics
  • Infant, Newborn
  • Cardiology
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
196
Not Provided
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 72 Hours   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01682122
SIUH12-037
SIUH12-037 ( Other Identifier: Staten Island University Hospital - IRB )
Yes
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Philip Roth, MD, PhD, Staten Island University Hospital
Staten Island University Hospital
Not Provided
Not Provided
Staten Island University Hospital
September 2012