A Longitudinal Study to Analyse the Correlation Between CAI and Bilirubin

NCT05287607 | Unknown

• 1 other identifier: 261277
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

In newborns, intravascular hemolysis (the breakdown of red blood cells inside the blood vessels) can range from mild, as part of the physiological (normal) turnover of red blood cells, to severe in cases such as jaundice (an increase in bilirubin levels) Early biomarkers of haemolysis would improve neonatology (newborn) practice by identifying at-risk patients, particularly if the assay is simple, rapid, non-invasive and quantitative. Our now-completed URICA trial on full-term male babies showed that the small cytoplasmic protein carbonic anhydrase I (CAI), found abundantly in red blood cells, was detected in 17 out of 26 urine samples collected once per recruited baby at the neonatology ward. CAI-positive samples were obtained from babies with levels of bilirubin that were rapidly rising or peaking above the threshold for phototherapy. CAI-negative urine was obtained when either bilirubin did not reach phototherapy (a light treatment used for excessive jaudice) threshold, or after it had recovered from its peak. On four occasions, the cause of CAI-positive urine was undetermined. Since CAI is normally absent from urine, a positive signal is indicative of intravascular hemolysis and confirms that CAI crossed the glomerular barrier (a barrier within the kidneys that filters large molecules). However, the quantitative power of urinary CAI to predict and estimate an impending haemolytic crisis requires a new longitudinal study, which is the objective of the URICA-II trial. The URICA-II trial would recruit 30 full term newborn infants delivered at the Evelina London Children's Hospital. The babies recruited would be expected to stay in the hospital for at least 5 days due to treatment for jaundice, infection or some other condition. Participants will have daily non-invasive (bag) urine samples collected and daily transcutaneous (skin) bilirubin levels recorded upto 10 days. The study will last upto 2 years.

Conditions

Hemolysis Neonatal

Outcome Measures

Primary Outcomes (1)

• CAI: Bilirubin correlation

  Correlate the time course of Carbonic Anhydrase I with bilirubin and demonstrate that CAI levels are an early indicator of jaundice.

  10 days

Secondary Outcomes (1)

• CAI Elisa kit performance

  10 days

Study Arms (1)

Newborn Infants

Newborn infants delivered at study hospital and admitted to neonatal unit. Babies anticipated to stay for at least 5 days.

Diagnostic Test: Urine sample for carbonic anydrase (I) levels

Interventions

Urine sample for carbonic anydrase (I) levels DIAGNOSTIC_TEST

Point of care diagnostic device used routinely for non-invasive estimation of serum bilrubin level.

Also known as: Transcutaneous bilirubin

Newborn Infants

Eligibility Criteria

• Age: Up to 1 Week
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Greater than 36 week gestation babies admitted to the neonatal unit

You may qualify if:

• Greater than 36 weeks gestation infants admitted to the neonatal unit and expected to be an in-patient for at least 5 days

You may not qualify if:

• Babies with chromosomal abnormalities

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University of Oxford: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

Study Officials

• Hammad Khan, MBBS

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Pawel Swietach

  University of Oxford

  STUDY DIRECTOR

Central Study Contacts

Hammad Khan, MBBS

CONTACT

+447790030773; hammad.khan@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share