Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02613676|
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Jaundice Hyperbilirubinemia||Device: Transcutaneous bilirubin screening Other: Standard care (Visual inspection)||Not Applicable|
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)
Babies ≥ 35 wks gestational age and/or ≥ 1800g, who are <72 hrs of life.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1858 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: TcB screening before discharge
Participants in this group will be screened for jaundice using the JM 105 transcutaneous device. The TcB value will be plotted on the Bhutani nomogram to assess the risk category. Infants who are categorised as high risk according to the nomogram will require blood sampling for TsB and assessment for need for phototherapy.
Device: Transcutaneous bilirubin screening
Transcutaneous bilirubin screening before hospital discharge and assessment of risk category according to the Bhutani nomogram
Standard care (visual inspection)
Participants in this group will be managed routinely according to the current standard of care where babies are assessed for jaundice by visual inspection. Babies in this group will require blood draw for TsB if there are visibly jaundiced
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.
- Readmission for hyperbilirubinemia [ Time Frame: Up to two weeks ]The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613676
|Cape Town, Western Cape, South Africa, 7560|
|Principal Investigator:||Charles I Okwundu, MBBS, MPH||University of Stellenbosch|
|Principal Investigator:||Vinod K Bhutani, MD||Stanford University|