Blood PressureNCT01682122
Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
An observational study of Blood Pressure and Pediatrics, run by Staten Island University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Pediatrics, Infant, Newborn
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.
Who may be able to join
- 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
Who cannot join
- Infants with gestational age < 35weeks or birth weight < 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
Philip Roth, MD, PhD
Omar Rodriguez, MD
About this study
Official title: 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
- Conditions
- Blood Pressure, Pediatrics, Infant, Newborn, Cardiology
- Keywords
- Blood Pressure, Pediatrics, Infant, Newborn, Cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 mins a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Staten Island University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Roth, MD, PhD, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682122
- Sponsor's protocol ID
- SIUH12-037
- Other IDs
- SIUH12-037
- Status last verified
- Sep 2012
- First submitted
- 5 Sep 2012
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population
- ClinicalTrials.gov ID
- NCT01682122
- Acronym / sponsor ID
- SIUH12-037
- Conditions
- Blood Pressure, Pediatrics, Infant, Newborn, Cardiology
- Keywords
- Blood Pressure, Pediatrics, Infant, Newborn, Cardiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Staten Island University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Infants with gestational age < 35weeks or birth weight < 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- institutional websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Pediatrics, run by Staten Island University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Roth, MD, PhD (718-226-9360, Philip_Roth@siuh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of wide pulse pressures in healthy newborn (time frame: 15 mins a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.