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 range1 Day – 28 Days

SexALL

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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

Trial details

NCT IDNCT06018012

SponsorTanta University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-03-01

View on ClinicalTrials.gov More Neonatal Hyperbilirubinemia trials