CompletedNot Applicable

MRA and ABR as Early Predictors of Bilirubin-Induced Neurologic Dysfunction in Full-term Jaundiced Neonates

Egypt76 participantsStarted 2019-03-01

Plain-language summary

The aim of the research was to define the role of MRS and ABR as early predictors of bilirubin-induced neurologic dysfunction (BIND) in full-term neonates who required intervention (phototherapy or exchange transfusion).

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Preterm neonates (less than 37 weeks).
. Clinically moderate and severe acute bilirubin encephalopathy according to modified Bilirubin-induced neurologic dysfunction (BIND-M) score.
. Neonates born with birth asphyxia and/or poor Apgar score.
. Neonates with sepsis including CNS infection.
. Neonates with family history of childhood hearing loss.
. Congenital infection.
. Chromosomal abnormalities.
. Congenital ear anomalies associated with hearing loss or brain abnormalities including craniofacial anomalies.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Early detection of neurological abnormalities using MRS metabolic ratios in high-risk neonates without oblivious clinical signs

Timeframe: 2 years

Early detection of neurological abnormalities using ABR parameters in high-risk neonates without oblivious clinical signs

Timeframe: 2 years

Bilirubin level and auditory abnormality

Timeframe: 2 years

Bilirubin level and MRS abnormality

Timeframe: 2 years

Trial details

NCT IDNCT06018012

SponsorTanta University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Neonatal Hyperbilirubinemia trials

Who can participate

Age range

1 Day – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Preterm neonates (less than 37 weeks).
. Clinically moderate and severe acute bilirubin encephalopathy according to modified Bilirubin-induced neurologic dysfunction (BIND-M) score.
. Neonates born with birth asphyxia and/or poor Apgar score.
. Neonates with sepsis including CNS infection.
. Neonates with family history of childhood hearing loss.
. Congenital infection.
. Chromosomal abnormalities.
. Congenital ear anomalies associated with hearing loss or brain abnormalities including craniofacial anomalies.

What they're measuring

Early detection of neurological abnormalities using MRS metabolic ratios in high-risk neonates without oblivious clinical signs

Timeframe: 2 years

Early detection of neurological abnormalities using ABR parameters in high-risk neonates without oblivious clinical signs

Timeframe: 2 years

Bilirubin level and auditory abnormality

Timeframe: 2 years

Bilirubin level and MRS abnormality

Timeframe: 2 years