Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00653874
First received: April 2, 2008
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Hyperbilirubinemia
Device: BiliChek (jaundice assessment)
Procedure: Transcutaneous bilirubinometry (TcB)
Other: Clinical asessment of bilirubin (CaB)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Routine Use of Transcutaneous Bilirubinometry Reduces the Need for Blood Sampling in Neonates With Jaundice

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Need for blood sampling for confirmation of serum total bilirubin in healthy term and near term neonates [ Time Frame: November 2006 to July 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the correlation and agreement of transcutaneous bilirubinometry (TcB) and clinical assessment of bilirubin (CaB) with measured STB. [ Time Frame: November 2006 to July 2007 ] [ Designated as safety issue: No ]

Enrollment: 617
Study Start Date: November 2006
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: TcB
transcutaneous bilirubinometry (TcB) 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)
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 168 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653874

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Satish Mishra, DM All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Ramesh Agarwal, AIIMS
ClinicalTrials.gov Identifier: NCT00653874     History of Changes
Other Study ID Numbers: neoaiims2007, drmishrasatish@gmail.com
Study First Received: April 2, 2008
Last Updated: April 4, 2008
Health Authority: India: Drugs Controller General of India

Keywords provided by All India Institute of Medical Sciences, New Delhi:
jaundice
neonates
transcutaneous bilirubinometry
clinical assessment of bilirubin

Additional relevant MeSH terms:
Hyperbilirubinemia
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014