Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
Condition: Neonatal Jaundice; Hyperbilirubinemia
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

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 description: 
      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:

      All participants in this group, will be assessed for the risk of severe hyperbilirubinemia by
      measurement of bilirubin level using the JM 105 transcutaneous device at < 72 hrs of life
      before hospital discharge. The bilirubin level will be plotted on the Bhutani hour-specific
      nomogram to determine the risk zone. Babies will be classified into four different different
      risk categories: high-risk, high-intermediate, low-intermediate and low risk categories
      depending on the transcutaneous bilirubin level. Follow-up or intervention will be planned
      based on the risk category. For participants who are identified as high risk for severe
      hyperbilirubinemia, the investigators will perform a formal TsB measurement and determine
      need for phototherapy.
    

Intervention name(s): Transcutaneous bilirubin screening; Standard care (Visual inspection)
Intervention type(s): Device; Other
Intervention description(s): Transcutaneous bilirubin screening before hospital discharge and assessment of risk category according to the Bhutani nomogram; 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.
Intervention MeSH terms: Bilirubin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening