Role of Serum (B/A) Ratio Compared to (TSB) for Early Prediction of Bilirubin-induced Neurological Dysfunction (BIND).

NCT06603753 | Not Yet Recruiting

• 1 other identifier: B/A ratio to predict of bind
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate serum bilirubin/albumin (B/A) ratio compared to total serum bilirubin (TSB) for early prediction of bilirubin-induced neurological dysfunction (BIND).

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (1)

• Early detection of cases of severe neonatal jaundice for exchange transfusion to avoid complications of kernicterus

  * The Bind score will be used. The BIND score includes 3 categories: mental status, muscle tone, and cry patterns. Each category will be given a score ranging from 0 to 3. * A BIND score of 7-9 will represent advanced signs of encephalopathy, Score of 4-6 will represent moderate signs of encephalopathy and Score of 1-3 encephalopathy subtle signs. Laboratory methods: * Blood sampling: venous blood will be obtained from each patient under aseptic conditions and collected into 3.2% sodium citrate tubes, except for CBC samples which will be drawn into EDTA tubes. * Complete blood count and reticulocyte count: The CBC and reticulocyte counts for both mothers and their babies will be analyzed using an automated hematology analyzer. The CBC parameters analyzed will include hemoglobin level, RBCs, WBCs, and platelet count. * Blood Grouping: Blood groups will be detected for both mother and her baby. * Liver function tests: The tests will include serum levels of AST, ALT, total bilirubin,

  baseline

Secondary Outcomes (1)

• Avoidance of complications of severe neonatal jaundice

  baseline

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Assiut university children hospital Prospective descriptive study

You may qualify if:

• Age: from 1 to 28 day.
• Full term and preterm babies.
• Both sexes.

You may not qualify if:

• Conjugated hyperbilirubinemia.
• Perinatal asphyxia.
• Patients with encephalopathy due to causes other than hyperbilirubinemia.
• Severe birth defects or congenital anomalies.
• Hemodynamic instability.
• Septic patients.

Sponsors & Collaborators

• alaa aboelhassan mohamed aboelhassan: lead

Related Publications (8)

• Karimzadeh P, Fallahi M, Kazemian M, Taslimi Taleghani N, Nouripour S, Radfar M. Bilirubin Induced Encephalopathy. Iran J Child Neurol. 2020 Winter;14(1):7-19.

  PMID: 32021624 BACKGROUND

• Hameed NN, Hussein MA. BIND score: A system to triage infants readmitted for extreme hyperbilirubinemia. Semin Perinatol. 2021 Feb;45(1):151354. doi: 10.1016/j.semperi.2020.151354. Epub 2020 Dec 1.

  PMID: 33309176 BACKGROUND

• Paar M, Fengler VH, Reibnegger G, Schnurr K, Waterstradt K, Schwaminger SP, Stauber RE, Oettl K. Determination of binding characteristics as a measure for effective albumin using different methods. Biochim Biophys Acta Gen Subj. 2023 Sep;1867(9):130427. doi: 10.1016/j.bbagen.2023.130427. Epub 2023 Jul 15.

  PMID: 37454915 BACKGROUND

• Wang Y, Sheng G, Shi L, Cheng X. Increased serum total bilirubin-albumin ratio was associated with bilirubin encephalopathy in neonates. Biosci Rep. 2020 Jan 31;40(1):BSR20192152. doi: 10.1042/BSR20192152.

  PMID: 31950971 BACKGROUND

• El Houchi SZ, Iskander I, Gamaleldin R, El Shenawy A, Seoud I, Abou-Youssef H, Wennberg RP. Prediction of 3- to 5-Month Outcomes from Signs of Acute Bilirubin Toxicity in Newborn Infants. J Pediatr. 2017 Apr;183:51-55.e1. doi: 10.1016/j.jpeds.2016.12.079. Epub 2017 Jan 25.

  PMID: 28131490 BACKGROUND

• Ding Y, Wang S, Guo R, Zhang A, Zhu Y. High levels of unbound bilirubin are associated with acute bilirubin encephalopathy in post-exchange transfusion neonates. Ital J Pediatr. 2021 Sep 15;47(1):187. doi: 10.1186/s13052-021-01143-z.

  PMID: 34526082 BACKGROUND

• Kang W, Yuan X, Zhang Y, Song J, Xu F, Liu D, Li R, Xu B, Li W, Cheng Y, Zhu C. Early prediction of adverse outcomes in infants with acute bilirubin encephalopathy. Ann Clin Transl Neurol. 2020 Jul;7(7):1141-1147. doi: 10.1002/acn3.51077. Epub 2020 Jun 4.

  PMID: 32495505 BACKGROUND

• Kasirer Y, Kaplan M, Hammerman C. Kernicterus on the Spectrum. Neoreviews. 2023 Jun 1;24(6):e329-e342. doi: 10.1542/neo.24-6-e329.

  PMID: 37258501 BACKGROUND

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Mahmoud A Ahmed, Dr

  Assiut University

  STUDY DIRECTOR

• Jaafar I Mohamad, Prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

alaa A mohamed

CONTACT

800 555 5555; aboelhassanalaa209@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 7, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09