Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
This study is not yet open for participant recruitment.
Verified September 2012 by Staten Island University Hospital
Sponsor:
Staten Island University Hospital
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 5, 2012 | ||||||||
| Last Updated Date | September 7, 2012 | ||||||||
| Start Date ICMJE | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01682122 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population | ||||||||
| Official Title ICMJE | Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population | ||||||||
| 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 |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 196 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 72 Hours | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01682122 | ||||||||
| Other Study ID Numbers ICMJE | SIUH12-037, SIUH12-037 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Philip Roth, MD, PhD, Staten Island University Hospital | ||||||||
| Study Sponsor ICMJE | Staten Island University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Staten Island University Hospital | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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