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Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

NCT02613676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1858

Last updated 2016-10-26

No results posted yet for this study

Summary

In South Africa, healthy term newborns are usually discharged early (\<72 hours after delivery). Many studies have shown that hospital readmission rates have increased with this practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have already been discharged putting the infant at increased risk of severe hyperbilirubinemia. Severe neonatal jaundice still constitutes an important cause of neonatal mortality and morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before hospital could help in early identification of hyperbilirubinemia and early intervention and potentially prevent unwanted consequences like bilirubin induced neurological dysfunction. However, there are conflicting recommendations on the use of universal transcutaneous bilirubin screening for jaundice in all newborns before hospital discharge.

Conditions

  • Neonatal Jaundice
  • Hyperbilirubinemia

Interventions

DEVICE

Transcutaneous bilirubin screening

Transcutaneous bilirubin screening before hospital discharge and assessment of risk category according to the Bhutani nomogram

OTHER

Standard care (Visual inspection)

Participants in this group will be assessed for jaundice by visual inspection. Blood draw for TsB will be drawn only if the participant is visibly jaundiced.

Sponsors & Collaborators

Principal Investigators

  • Charles I Okwundu, MBBS, MPH · University of Stellenbosch

  • Vinod K Bhutani, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • South Africa

Study Locations

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Entities

Companies

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 NCT02613676 on ClinicalTrials.gov