Value of Transcutaneous Bilirubin Devices

NCT06232174 | Not Yet Recruiting

• 1 other identifier: transcutaneous bilirubin
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the value of transcutaneous bilirubin devices versus serum bilirubin in jaundiced neonates

Conditions

Jaundice

Keywords

Neonatal jaundice

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

jaundiced neonates followed in assiut university children\'s hospital

You may qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (9)

• 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.

  PMID: 18929553 BACKGROUND

• 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.

  PMID: 23043681 BACKGROUND

• Ministry of Health Malaysia. Clinical practice guidelines: management of neonatal jaundice. 2nd ed. Kuala Lumpur, Malaysia: Ministry of Health; 2014.

  BACKGROUND

• 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.

  PMID: 35283687 BACKGROUND

• 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.

  PMID: 15231951 BACKGROUND

• 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.

  PMID: 25601981 BACKGROUND

• 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.

  PMID: 29637112 BACKGROUND

• 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.

  PMID: 25282473 BACKGROUND

• 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.

  PMID: 13851385 BACKGROUND

MeSH Terms

Conditions

Jaundice; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohammed Gamil, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Marina Farah Fawzy Gad, Master

CONTACT

01069928577; m_marina70@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 25 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric resident

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

EG (1)