Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Staten Island University Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Philip Roth, MD, PhD, Staten Island University Hospital
ClinicalTrials.gov Identifier:
NCT01682122
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012

September 5, 2012
September 7, 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 ] [ Designated as safety issue: No ]
This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life.
Same as current
Complete list of historical versions of study NCT01682122 on ClinicalTrials.gov Archive Site
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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

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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
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
196
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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.
Both
up to 72 Hours
Yes
Contact: Philip Roth, MD, PhD 718-226-9360 Philip_Roth@siuh.edu
Contact: Omar Rodriguez, MD 7186793745 omarrodriguez.md@gmail.com
United States
 
NCT01682122
SIUH12-037, SIUH12-037
Yes
Philip Roth, MD, PhD, Staten Island University Hospital
Staten Island University Hospital
Not Provided
Not Provided
Staten Island University Hospital
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP