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Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

S

Staten Island University Hospital

Status

Unknown

Conditions

Cardiology
Pediatrics
Infant, Newborn
Blood Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT01682122
SIUH12-037 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

196 estimated patients

Sex

All

Ages

Under 72 hours old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

196 participants in 1 patient group

Newborns
Description:
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

Trial contacts and locations

1

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Central trial contact

Omar Rodriguez, MD; Philip Roth, MD, PhD

Data sourced from clinicaltrials.gov

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