Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
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.
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.
Inclusion Criteria:

 -  All newborns ≥ 35 wks gestational age and ≥ 1800g

 -  Babies who who are < 72 hours of life

 Exclusion Criteria:

 -  Prior use of phototherapy

 -  Major congenital anomaly

 -  Babies born < 35 wks gestational age or < 1800g