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

NCT06018012 | Completed

• 1 other identifier: MRS& ABR in jaundiced neonates
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (4)

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

  Early detection of neurological abnormalities in high-risk neonates, without oblivious clinical signs, chemically by using MRS metabolic ratio ( low NAA/Cr, NAA/Cho ratios, and high Lac/Cr ratio).

  2 years

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

  Early detection of neurological abnormalities in high-risk neonates, without oblivious clinical signs, functionally through ABR parameters ( prolonged wave III peak latency, wave V peak latency, I-III interpeak interval, and I-V interpeak interval )

  2 years

• Bilirubin level and auditory abnormality

  Finding out the lowest level of total serum bilirubin at which auditory pathway abnormality was found, in comparison to age.

  2 years

• Bilirubin level and MRS abnormality

  Finding out the lowest level of total serum bilirubin at which MRS abnormalities were found, in comparison to age.

  2 years

Secondary Outcomes (2)

• Discriminative capacity of MRS for acute bilirubin encephalopathy

  2 years

• Discriminative capacity of ABR for acute bilirubin encephalopathy

  2 years

Study Arms (3)

1 or acute bilirubin encephalopathy

Group (1): included 26 cases with BIND or acute bilirubin encephalopathy (ABE).

Device: MRS and ABR

2 or neonatal hyperbilirubinemia

Group (2): included 30 cases with neonatal hyperbilirubinemia on

Device: MRS and ABR

Control

control group: 20 healthy, age-matched neonates

Device: MRS and ABR

Interventions

MRS and ABR DEVICE

Magnetic Resonance Spectroscopy and Auditory Brain- stem Response Audiometry

1 or acute bilirubin encephalopathy; 2 or neonatal hyperbilirubinemia; Control

Eligibility Criteria

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

Study Population

This study included term, appropriate for gestational age (AGA) neonates with pathological unconjugated hyperbilirubinemia who were candidates for intervention (Intensive phototherapy versus Exchange transfusion) using the American Academy of Pediatrics guidelines; 2004. In addition, 20 healthy, age-matched neonates were included as controls.

You may qualify if:

• This study included term, appropriate for gestational age (AGA) neonates with pathological unconjugated hyperbilirubinemia who were candidates for intervention (Intensive phototherapy versus Exchange transfusion) using the American Academy of Pediatrics guidelines; 2004.

You may not qualify if:

• 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.
• Patients who were receiving ototoxic drugs as aminoglycosides.
• Conjugated hyperbilirubinemia.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of medicine,Tanta University

Tanta, Q2x2+cp Tanta 2, 31527, Egypt

Location

Related Publications (7)

• Watchko JF, Tiribelli C. Bilirubin-induced neurologic damage--mechanisms and management approaches. N Engl J Med. 2013 Nov 21;369(21):2021-30. doi: 10.1056/NEJMra1308124. No abstract available.

  PMID: 24256380 BACKGROUND

• Usman, F., Diala, U., Shapiro, S., Le Pichon, J.-B., & Slusher, T. Acute bilirubin encephalopathy and its progression to kernicterus: current perspectives. Research and Reports in Neonatology, 8, 33-44 (2018).

  BACKGROUND

• Watchko JF. Bilirubin-Induced Neurotoxicity in the Preterm Neonate. Clin Perinatol. 2016 Jun;43(2):297-311. doi: 10.1016/j.clp.2016.01.007. Epub 2016 Mar 2.

  PMID: 27235209 BACKGROUND

• Das S, van Landeghem FKH. Clinicopathological Spectrum of Bilirubin Encephalopathy/Kernicterus. Diagnostics (Basel). 2019 Feb 28;9(1):24. doi: 10.3390/diagnostics9010024.

  PMID: 30823396 BACKGROUND

• Teixeira MH, Borges VMS, Riesgo RDS, Sleifer P. Hyperbilirubinemia impact on newborn hearing: a literature review. Rev Assoc Med Bras (1992). 2020 Jul;66(7):1002-1008. doi: 10.1590/1806-9282.66.7.1002. Epub 2020 Aug 24.

  PMID: 32844928 BACKGROUND

• Olds C, Oghalai JS. Audiologic impairment associated with bilirubin-induced neurologic damage. Semin Fetal Neonatal Med. 2015 Feb;20(1):42-46. doi: 10.1016/j.siny.2014.12.006. Epub 2015 Jan 7.

  PMID: 25575899 BACKGROUND

• Zidan LK, Rowisha MA, Nassar MAE, Elshafey RA, El Mahallawi TH, Elmahdy HS. Magnetic resonance spectroscopy and auditory brain-stem response audiometry as predictors of bilirubin-induced neurologic dysfunction in full-term jaundiced neonates. Eur J Pediatr. 2024 Feb;183(2):727-738. doi: 10.1007/s00431-023-05246-z. Epub 2023 Nov 18.

  PMID: 37979048 DERIVED

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 30, 2023
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

EG (1)