Clinical trial NCT02613676: Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
Official title: Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Hyperbilirubinemia
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2015-11-24
Enrollment: 1858
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Readmission for hyperbilirubinemia
timeFrame: Up to two weeks
Secondary outcomes:
measure: Phototherapy before discharge
timeFrame: Up to two weeks
measure: TsB > 427 umol/l or TsB > threshold for exchange transfusion
timeFrame: Up to two weeks
measure: Length of hospital stay (days)
timeFrame: Up to two weeks
measure: Blood draw for total serum bilirubin
timeFrame: Up to two week
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
state: Western Cape
Study officials:
affiliation: University of Stellenbosch
name: Charles I Okwundu, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Vinod K Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References: