Clinical Trial: Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

Brief 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.

Detailed Summary:

Like in many other countries in Africa and the rest of the world, objective screening for risk of severe hyperbilirubinemia using serum bilirubin (TsB) or transcutaneous bilirubin (TcB) measurement is currently not standard of care in South Africa. The investigators therefore propose to test the use of a non-invasive TcB device to detect and predict the risk of severe jaundice before discharge of babies from the new-born nursery in a South African population of newborns.

OBJECTIVE To evaluate the effects of transcutaneous bilirubin screening in newborns before hospital discharge.

METHODS In this randomised controlled trial (RCT) the investigators will compare the traditional visual assessment and TcB measurement before hospital discharge. About 1858 newborns ≥35 weeks gestational age and/or ≥1800 g, who are <72 hrs of life will be randomly allocated into two groups: a) TcB screening, or b) visual assessment (standard care)

Subjects:

Babies ≥ 35 wks gestational age and/or ≥ 1800g, who are <72 hrs of life.

Study arms:

Participants will be randomised within 72 hrs of birth into: a) TcB screening plotted on the nomogram or b) visual assessment of jaundice.

Control group (Standard care):

In this group, participants will be assessed for jaundice by the use of the traditional visual assessment before discharge. A formal serum bilirubin level will be done on all infants who are visibly jaundiced and decide on need for phototherapy.

TcB screening group:

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Sponsor: University of Stellenbosch

Current Primary Outcome: Readmission for hyperbilirubinemia [ Time Frame: Up to two weeks ]

The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Phototherapy before discharge [ Time Frame: Up to two weeks ]
    This outcome refers to the use of phototherapy for the treatment of hyperbilirubinemia before hospital discharge.
  • TsB > 427 umol/l or TsB > threshold for exchange transfusion [ Time Frame: Up to two weeks ]
  • Length of hospital stay (days) [ Time Frame: Up to two weeks ]
  • Blood draw for total serum bilirubin [ Time Frame: Up to two week ]
    This outcome refers to blood sampling for laboratory measurement of TsB


Original Secondary Outcome: Same as current

Information By: University of Stellenbosch

Dates:
Date Received: November 17, 2015
Date Started: August 2015
Date Completion:
Last Updated: October 24, 2016
Last Verified: October 2016