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

September 17, 2024 updated by: alaa aboelhassan mohamed aboelhassan

Use of Serum Bilirubin/Albumin Ratio for Early Prediction of Bilirubin Induced Neurological Dysfunction

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Introduction Neonatal hyperbilirubinemia is a common problem in neonates. Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life and about 10% of breastfed babies are still jaundiced at 1 month.

Jaundice due to either indirect (unconjugated) or direct (conjugated) bilirubin within the first 24 h of life should be taken seriously. Early identification and proper management are needed to prevent the serious neurological complications .

When the total serum bilirubin (TSB) rises above the 95th percentile for age (high-risk zone), entry of unconjugated bilirubin into the brain can cause both short-term and long-term neurological dysfunctions (bilirubin encephalopathy) . The increased level of bilirubin is detrimental for nervous system, especially damage the basal ganglia, cerebellum, and brainstem, thus, resulting in bilirubin-induced neurological dysfunction (BIND) .

Bilirubin-induced neurologic dysfunction (BIND) is the term applied to the spectrum of neurologic abnormalities associated with hyperbilirubinemia. It can be further divided into characteristic signs and symptoms that appear in the early stages (acute) and those that evolve over a prolonged period (chronic) . Signs and symptoms of BIND include tone abnormalities such as hypotonia, hypertonia, retrocollis and opisthotonos, in association with varying degrees of drowsiness, lethargy, decreased feeding and irritability .

BIND was also associated with Kernicterus leading to devastating disability including athetoid cerebral palsy, speech and hearing impairment. BIND in neonates is a significant cause of death or lifelong disability, including cerebral palsy (CP) and auditory disorders .

The earliest signs and symptoms of BIND are nonspecific therefore may be easily missed thus an early diagnostic tool is required. BIND score is a scoring system, in which characteristics of mental state, muscle tone, and cry are grouped into three levels of increasing abnormality: stage IA, minimal signs; stage IB, progressive but reversible with treatment; stage II, advanced and largely irreversible, but may be significantly decreased by treatment .

The pathogenesis of BIND is multifactorial and includes interaction between the level of unconjugated bilirubin, free bilirubin, bilirubin bound to albumin, bilirubin passed through brain blood barrier and nerves damage. Although 99.9% of unconjugated bilirubin in the circulation is bound to albumin, a relatively small fraction (only less than 0.1%) remains unbound (free bilirubin) and it can go into the brain across an intact blood brain barrier (BBB) .

There is currently no method available for measuring free bilirubin concentrations accurately in plasma or serum; therefore, adjunct measurements of albumin concentration and bilirubin albumin ratio (B/A) may provide more insight into the likelihood of bilirubin-induced encephalopathy. The B/A ratio is considered a surrogate parameter for free bilirubin and an interesting additional parameter in the management of hyperbilirubinemia. Few studies suggested the utilization of B/A ratios as a predictor for bilirubin-induced neurotoxicity .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Assiut university children hospital Prospective descriptive study

Description

Inclusion Criteria:• Neonates with hyperbilirubinemia reached level of phototherapy or exchange transfusion according to the American Academy of Pediatrics guidelines [14].

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early detection of cases of severe neonatal jaundice for exchange transfusion to avoid complications of kernicterus
Time Frame: baseline
  • 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Avoidance of complications of severe neonatal jaundice
Time Frame: baseline
  • 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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
alaa aboelhassan mohamed aboelhassan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mahmoud A Ahmed, Dr, Assiut University
  • Study Director: Jaafar I Mohamad, Prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B/A ratio to predict of bind

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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