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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-28
Sponsoralaa aboelhassan mohamed aboelhassan

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: from 1 to 28 day.

Full term and preterm babies.

Both sexes.

Disqualifiers

Conjugated hyperbilirubinemia.

Perinatal asphyxia.

Patients with encephalopathy due to causes other than hyperbilirubinemia.

Severe birth defects or congenital anomalies.

Trial population

Assiut university children hospital Prospective descriptive study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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,

Time frame
baseline

Secondary outcomes

1

Avoidance of complications of severe neonatal jaundice

* Personal data including age and sex, demographics including residence and socioeconomic status. * Clinical data including vital signs, body mass index (BMI) and the BIND score. * Laboratory data including Complete blood count and reticulocyte count, blood grouping for mother and baby, liver and bilirubin to albumin ration

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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alaa aboelhassan mohamed aboelhassan

Lead sponsor

Assiut University

Sponsor institution

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