Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects
Clinical Investigation for Non-invasive Blood Pressure Monitor Accuracy Validation Performed on Neonatal, Infants and Children up to 3 Years Old
1 other identifier
observational
25
1 country
2
Brief Summary
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedMarch 23, 2016
March 1, 2016
5 months
December 22, 2015
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study is the non-invasive blood pressure measurements accuracy validation performed with the Surveyor S12 / S19 monitor in pediatric, infants and children up to 3 years patients per ISO 81060-2: 2013 requirements.
To study the accuracy of non-invasive blood pressure measurements in neonatal patients
4 hours per patient
Interventions
Non-invasive blood pressure measurement
Eligibility Criteria
The study will include a minimum of 25 patients for the Method 1 and 20 patient for the Method 2, male and female, with the following weight and age (as defined by date of birth to current date; not gestational age) ranges: * At least 3 patients \< 1,000 g in weight. * At least 3 patients 1,000 g to 2,000 g in weight. * At least 3 patients \> 2,000 g in weight. * At least 3 patients ≥ to 29 days and \< 1 year of age. * At least 3 patients ≥ 1 year and \< 3 years of age.
You may qualify if:
- Before proceeding with the blood pressure non-invasive measurements detection, patients shall be examined and met the following stated criteria:
- Patients shall have already an invasive blood pressure monitoring (with catheter), this criteria applies only for Method 1.
- It shall be possible to perform multiple measurements of Non Invasive Blood pressure on one or more limbs with inflatable cuff.
- Patient with weight and age range according to the protocol requirements previously defined.
You may not qualify if:
- Patients with unstable clinical or cardiovascular conditions;
- Patients with circulatory problems which can results in different blood pressure values in the limbs;
- patients with heart disease which can results in blood pressure wave morphology abnormalities;
- patients where the difference of systolic blood pressure between two limbs is greater than 15 mm Hg or the difference of lateral diastolic blood pressure is greater than 10mmHg;
- Patients with arrhythmias.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ospedale Pediatrico Bambino Gesù (OPBG)
Rome, Italy, 00165, Italy
U.O. Neonatal Intensive Care Immature Pediatric Hospital Bambino Gesù - IRCCS
Rome, 00165, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2015
First Posted
December 30, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2016
Last Updated
March 23, 2016
Record last verified: 2016-03