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Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

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ClinicalTrials.gov Identifier: NCT02613676
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Charles Okwundu, University of Stellenbosch

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.

Condition or disease Intervention/treatment Phase
Neonatal Jaundice Hyperbilirubinemia Device: Transcutaneous bilirubin screening Other: Standard care (Visual inspection) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1858 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Readmission for hyperbilirubinemia [ Time Frame: Up to two weeks ]
    The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion


Secondary Outcome Measures :
  1. 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.

  2. TsB > 427 umol/l or TsB > threshold for exchange transfusion [ Time Frame: Up to two weeks ]
  3. Length of hospital stay (days) [ Time Frame: Up to two weeks ]
  4. Blood draw for total serum bilirubin [ Time Frame: Up to two week ]
    This outcome refers to blood sampling for laboratory measurement of TsB



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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South Africa
Tygerberg Hospital
Cape Town, Western Cape, South Africa, 7560
Sponsors and Collaborators
University of Stellenbosch
Stanford University
Investigators
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Principal Investigator: Charles I Okwundu, MBBS, MPH University of Stellenbosch
Principal Investigator: Vinod K Bhutani, MD Stanford University

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Responsible Party: Charles Okwundu, Researcher, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT02613676     History of Changes
Other Study ID Numbers: TcBScreening
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Bilirubin
Jaundice
Hyperbilirubinemia
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs