Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

Neonatal Jaundice Clinical Trial

Official title:

Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613676
• Other study ID #: TcBScreening
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: October 24, 2016
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Stellenbosch
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1858
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

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.

Locations

Country	Name	City	State
South Africa	Tygerberg Hospital	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Stellenbosch	Stanford University

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission for hyperbilirubinemia	The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion	Up to two weeks	No
Secondary	Phototherapy before discharge	This outcome refers to the use of phototherapy for the treatment of hyperbilirubinemia before hospital discharge.	Up to two weeks	No
Secondary	TsB > 427 umol/l or TsB > threshold for exchange transfusion		Up to two weeks	No
Secondary	Length of hospital stay (days)		Up to two weeks	No
Secondary	Blood draw for total serum bilirubin	This outcome refers to blood sampling for laboratory measurement of TsB	Up to two week	No