Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial

BACKGROUND: For evaluation of jaundiced neonates, serum bilirubin (SB) or transcutaneous bilirubinometry (TcB) is used. Few data are available on the quantitative reduction of blood sampling by using TcB. METHODS: We conducted a randomized controlled trial in hospitalized jaundiced neonates ≥32 weeks’ gestational age. In the intervention group, TcB was used and in the control group the decision to obtain a blood sample for SB was based on visual and clinical assessment. Outcome measure was the number of blood samples before phototherapy. When TcB was <50 μmol/L below the threshold for phototherapy, SB was obtained. The decision to start treatment was always based on an SB value. RESULTS: A total of 430 were randomized and included in the intention-to-treat analysis: 213 in the TcB group and 217 in the control group. In the TcB group, 104 (48.4%) had at least 1 blood sample taken for SB, versus 172 (79.3%) in the control group (difference 30.5%, 95% confidence interval 21.5–38.7, P < .001). The number of blood draws was significantly reduced by 38.5% (0.9 ± 1.1 vs 1.3 ± 1.0, difference –0.5, 95% confidence interval –0.7 to –0.3, P < .001). Peak of bilirubin value, indications for phototherapy, or exchange transfusion and hospitalization length were not different between groups. CONCLUSIONS: The use of TcB in jaundiced neonates is feasible and safe, resulting in a reduction of more than one-third in blood draws. Department of Pediatrics, Amalia Children’s Clinic, Isala, Zwolle, Netherlands Ms van den Esker-Jonker conceptualized and designed the study, and revised the article; Ms den Boer carried out the data collection and the initial analyses on the maternity ward, and drafted the initial manuscript; Dr Pepping carried out the data collection and the initial analyses of the neonatal ward, and drafted the initial manuscript; Dr Bekhof designed the study, coordinated and supervised the process, critically reviewed the manuscript, and wrote the fi nal draft as submitted; and all authors approved the fi nal manuscript as submitted and agree to be accountable for all aspects of the work. This trial has been registered at www. clinicaltrials. gov (identifi er NCT01622699). DOI: 10.1542/peds.2016-2414 Accepted for publication Sep 1, 2016 Address correspondence to Jolita Bekhof, MD, PhD, Amalia Children’s Clinic, Isala, Postbus 10400, 8000 GK Zwolle, The Netherlands. E-mail: [email protected] PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2016 by the American Academy of Pediatrics FINANCIAL DISCLOSURE: The authors have indicated they have no fi nancial relationships relevant to this article to disclose. FUNDING: Isala’s Foundation for Innovation and Research funded this study. To cite: van den Esker-Jonker B, den Boer L, Pepping RM, et al. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016; 138(6):e20162414 WHAT’S KNOWN ON THIS SUBJECT: The use of transcutaneous bilirubinometry (TcB) in jaundiced newborns for screening of severe hyperbilirubinemia is valid and well investigated. Its use is advised in major international guidelines. However, TcB is not widely used yet, especially not in sick, hospitalized neonates. WHAT THIS STUDY ADDS: This study shows that the use of TcB is feasible, safe, and leads to a reduction of one-third in blood draws in hospitalized neonates. These data can be helpful during decision-making about implementing TcB in pediatric wards. by guest on December 29, 2016 Downloaded from VAN DEN ESKER-JONKER et al Active screening of newborns at risk for neonatal jaundice for severe hyperbilirubinemia is advised in major international guidelines. 1 – 3 Visual assessment of neonatal jaundice is known to be unreliable 2, 4 and determination of serum bilirubin (SB) is, after the routine screening for inborn errors, the most frequent reason for blood draws in neonates. 5, 6 Although the use of transcutaneous bilirubin (TcB) measurement is a valid method for determination of the severity of jaundice and is used in increasing frequency, its use is still not widespread worldwide yet. 7 –9 In February 2016, we performed a telephonic review among most Dutch hospitals with neonatal wards (n = 37), which revealed that TcB was used in only 27% of these wards. Moreover in a Delphi study, the utility of TcB in jaundiced neonates was in the top 10 of most important research topics in neonatology. 10 Possibly, a low confidence in bilirubinometry plays a role here, based on earlier studies using older nonvalid techniques. 11 One reason of nonapplication of TcB may be the assumption that in sick neonates TcB is less useful, because in these neonates blood sampling is often done for other indications and SB measurement is simultaneously measured. Furthermore, in lowincome countries, TcB is not widely applied, although this may be of great value due to feasibility of TcB in community settings with low resources. 12, 13 Since the 1980s, the use of a transcutaneous bilirubinometer has already been described to decrease blood draws and costs. However, quantitative data on the amount of reduction in blood draws from prospective studies are sparse. 5 – 11, 14, 15 Most published data on the use of TcB originate from validation studies, comparing SB with TcB, by using a retrospective or observational study design in community settings or nurseries, in mostly relatively healthy (near) term populations.4 – 6, 8, 14 – 17 Recently, it has been shown that the use of TcB can be applied reliably in preterm infants with gestational age of 28 to 35 weeks as well, 18, 19 emerging the question of what reduction in blood draws can be achieved in this group of neonates? This study aims to quantify the reduction in blood draws as a result of implementing a TcB in hospitalized jaundiced neonates from 32 weeks of gestational age, compared with visual assessment with subsequent blood sampling for determination of SB.