Jaundice Clinical Trial
Official title:
Study of the Value of Transcutaneous Bilirubin Devices in Jaundiced Newborns at Assiut University Children's Hospital
The goal of this observational study is to compare the value of transcutaneous bilirubin devices versus serum bilirubin in jaundiced neonates
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 28 Days |
Eligibility | Inclusion Criteria: - They were born between 35 and 42 weeks of gestation, had a birth weight of more than 2 kg, and were aged between 0 days and 28 days Exclusion Criteria: - Exclusion criteria are severely ill neonates, neonates with a lethal congenital malformation, and or had skin disease, had received phototherapy before, and received exchange transfusion. |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297. Erratum In: Pediatrics. 2004 Oct;114(4):1138. — View Citation
Bhutani VK, Stark AR, Lazzeroni LC, Poland R, Gourley GR, Kazmierczak S, Meloy L, Burgos AE, Hall JY, Stevenson DK; Initial Clinical Testing Evaluation and Risk Assessment for Universal Screening for Hyperbilirubinemia Study Group. Predischarge screening for severe neonatal hyperbilirubinemia identifies infants who need phototherapy. J Pediatr. 2013 Mar;162(3):477-482.e1. doi: 10.1016/j.jpeds.2012.08.022. Epub 2012 Oct 5. — View Citation
Carceller-Blanchard A, Cousineau J, Delvin EE. Point of care testing: transcutaneous bilirubinometry in neonates. Clin Biochem. 2009 Feb;42(3):143-9. doi: 10.1016/j.clinbiochem.2008.09.106. Epub 2008 Oct 2. — View Citation
Engle WD, Jackson GL, Engle NG. Transcutaneous bilirubinometry. Semin Perinatol. 2014 Nov;38(7):438-51. doi: 10.1053/j.semperi.2014.08.007. Epub 2014 Oct 3. — View Citation
GOSSET IH. A perspex icterometer for neonates. Lancet. 1960 Jan 9;1(7115):87-8. doi: 10.1016/s0140-6736(60)92902-0. No abstract available. — View Citation
Hussain AS, Shah MH, Lakhdir M, Ariff S, Demas S, Qaiser F, Ali SR. Effectiveness of transcutaneous bilirubin measurement in managing neonatal jaundice in postnatal ward of a tertiary care hospital in Pakistan. BMJ Paediatr Open. 2017 Aug 31;1(1):e000065. doi: 10.1136/bmjpo-2017-000065. eCollection 2017. — View Citation
Ministry of Health Malaysia. Clinical practice guidelines: management of neonatal jaundice. 2nd ed. Kuala Lumpur, Malaysia: Ministry of Health; 2014.
Mohamed M, Ibrahim NR, Ramli N, Abdul Majid N, Yacob NM, Nasir A. Comparison between the Transcutaneous and Total Serum Bilirubin Measurement in Malay Neonates with Neonatal Jaundice. Malays J Med Sci. 2022 Feb;29(1):43-54. doi: 10.21315/mjms2022.29.1.5. Epub 2022 Feb 23. — View Citation
Taylor JA, Burgos AE, Flaherman V, Chung EK, Simpson EA, Goyal NK, Von Kohorn I, Dhepyasuwan N; Better Outcomes through Research for Newborns Network. Discrepancies between transcutaneous and serum bilirubin measurements. Pediatrics. 2015 Feb;135(2):224-31. doi: 10.1542/peds.2014-1919. Epub 2015 Jan 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diagnostic accuracy of transcutaneous bilirubin devices as a diagnostic test for hyperbilirubinaemia in newborns | diagnostic test accuracy studies comparing TcB and TsB measurement for hyperbilirubinaemia in newborns | 20 days |
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