MedTrace Logo

Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates

NCT00653874 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2008-04-07

No results posted yet for this study

Summary

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.

Conditions

  • Hyperbilirubinemia

Interventions

DEVICE

BiliChek (jaundice assessment)

assessment of jaundice was done by either transcutaneous bilirubinometry (TcB) method or by clinical assessment of bilirubin (CaB)

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

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

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Satish Mishra, DM · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
24 Hours
Max Age
168 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-07-31
Completion
2007-08-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00653874 on ClinicalTrials.gov