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Transcutaneous Bilirubinometry in Neonates With the Bilicare System

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ClinicalTrials.gov Identifier: NCT02445755
Recruitment Status : Completed
First Posted : May 15, 2015
Results First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
Vinod K. Bhutani, Stanford University

Brief Summary:
The purpose of this study is to test the performance of a new transcutaneous ("measured through skin") bilirubin device (BiliCare™) to measure bilirubin levels. The investigators plan to evaluate the clinical performance of this device as a point of care test. If the investigators can validate the BiliCare™ with bilirubin from your baby's blood they could verify a non-invasive alternative for measuring bilirubin.

Condition or disease
Transcutaneous Bilirubinometry

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transcutaneous Bilirubinometry in Neonates With the Bilicare System
Study Start Date : June 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015



Primary Outcome Measures :
  1. In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours. [ Time Frame: 12 to 48 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 100 total participants will be enrolled by the study. Since the goal of the study is to ASSAY SAMPLE FROM BABIES WITH DIVERSE BILIRUBIN LEVELS, the study participants will be moderate premature and mature infants. In particular, the target population will be moderate premature infants at >35 weeks postmenstrual age (PMA) and of term PMA.
Criteria

Inclusion Criteria:

  1. Parental informed consent
  2. Male and female newborns with a GA ≥ 35 wks
  3. Enrollment at age > 6 hrs until neonatal discharge
  4. Pre-phototherapy

Exclusion Criteria:

  1. Infants requiring respiratory assistance (such as mechanical ventilation)
  2. Severe or life-threatening congenital anomalies
  3. Hematomas at the point of measurement on both ears
  4. Neonates undergone blood transfusion

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Responsible Party: Vinod K. Bhutani, MD, Stanford University
ClinicalTrials.gov Identifier: NCT02445755     History of Changes
Obsolete Identifiers: NCT02372045
Other Study ID Numbers: 30820
First Posted: May 15, 2015    Key Record Dates
Results First Posted: June 4, 2015
Last Update Posted: June 4, 2015
Last Verified: May 2015

Keywords provided by Vinod K. Bhutani, Stanford University:
Neonates
Bilicare System