Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates
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ClinicalTrials.gov Identifier: NCT00653874 |
Recruitment Status :
Completed
First Posted : April 7, 2008
Last Update Posted : April 7, 2008
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Objectives: Bilirubin measured by transcutaneous bilirubinometry (TcB) is a reasonably accurate estimate of serum total bilirubin (STB). Observational studies indicate that replacing clinical assessment of bilirubin (CaB) with TcB may result in reduced need for blood sampling for STB estimation. Objective of this study was to determine if routine use of transcutaneous bilirubinometry decrease the need for blood sampling for confirmation of STB in healthy term and near term neonates?
Study design: Study was conducted as a randomized controlled trial at a tertiary care neonatal unit. Healthy neonates born at 35 or more completed weeks of gestation were eligible for enrolment if they had clinically evident jaundice during first week of life. In each enrolled neonate, level of jaundice was assessed by two methods - CaB followed by TcB (BiliCheck®, SpectRx Inc, Norcross, GA). By random allocation method, one of these estimates was used for deciding the need for blood sampling to confirm STB. Need for blood sampling was defined to be present if the bilirubin assessed by the allocated method exceeded 80% of age-specific cut-off for phototherapy as per American Academy of Pediatrics 2004 guidelines. Study had ethics clearance and written informed consent was obtained from parents.
Condition or disease | Intervention/treatment | Phase |
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Hyperbilirubinemia | Device: BiliChek (jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB) Other: Clinical asessment of bilirubin (CaB) | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 617 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Diagnostic |
Official Title: | Routine Use of Transcutaneous Bilirubinometry Reduces the Need for Blood Sampling in Neonates With Jaundice |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | August 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: 1: TcB
transcutaneous bilirubinometry (TcB) was used for deciding the need for blood sampling to measure serum total bilirubin (STB)
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Device: BiliChek (jaundice assessment)
assessment of jaundice was done by either transcutaneous bilirubinometry (TcB) method or by clinical assessment of bilirubin (CaB)
Other Name: BiliChek (transcutaneous bilirubin measuring device) Procedure: Transcutaneous bilirubinometry (TcB) transcutaneous bilirubinometry was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life |
Active Comparator: 2: CaB
clinical assessment of jaundice (CaB) was used for deciding the need for blood sampling to measure serum total bilirubin (STB)
|
Device: BiliChek (jaundice assessment)
assessment of jaundice was done by either transcutaneous bilirubinometry (TcB) method or by clinical assessment of bilirubin (CaB)
Other Name: BiliChek (transcutaneous bilirubin measuring device) Other: Clinical asessment of bilirubin (CaB) Clinical assessment of bilirubin (CaB) was used for jaundice assessment in healthy term and near-term jaundiced neonates between 24 to 168 hours of life |
- Need for blood sampling for confirmation of serum total bilirubin in healthy term and near term neonates [ Time Frame: November 2006 to July 2007 ]
- the correlation and agreement of transcutaneous bilirubinometry (TcB) and clinical assessment of bilirubin (CaB) with measured STB. [ Time Frame: November 2006 to July 2007 ]

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Ages Eligible for Study: | up to 168 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Neonates born at 35 or more completed weeks of gestation with clinical jaundice and age between 25 to 168 hours
Exclusion Criteria:
- Neonates with Rh hemolytic disease those requiring NICU admission for more than 24 h having major congenital malformation or having received phototherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653874
India | |
All India Institute of Medical Sciences | |
New Delhi, Delhi, India, 110029 |
Principal Investigator: | Satish Mishra, DM | All India Institute of Medical Sciences, New Delhi |
Responsible Party: | Dr Ramesh Agarwal, AIIMS |
ClinicalTrials.gov Identifier: | NCT00653874 |
Other Study ID Numbers: |
neoaiims2007 drmishrasatish@gmail.com |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | April 7, 2008 |
Last Verified: | April 2008 |
jaundice neonates transcutaneous bilirubinometry clinical assessment of bilirubin |
Hyperbilirubinemia Pathologic Processes Bilirubin Antioxidants |
Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |