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A Longitudinal Study to Analyse the Correlation Between CAI and Bilirubin

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ClinicalTrials.gov Identifier: NCT05287607
Recruitment Status : Not yet recruiting
First Posted : March 18, 2022
Last Update Posted : March 18, 2022
University of Oxford
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Hemolysis Neonatal Diagnostic Test: Urine sample for carbonic anydrase (I) levels

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: URICA-II; a Longitudinal Study to Analyse the Correlation Between Urinary Carbonic Anhydrase (CAI), a Marker of Haemolysis, and Bilirubin
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
Point of care diagnostic device used routinely for non-invasive estimation of serum bilrubin level.
Other Name: Transcutaneous bilirubin

Primary Outcome Measures :
  1. CAI: Bilirubin correlation [ Time Frame: 10 days ]
    Correlate the time course of Carbonic Anhydrase I with bilirubin and demonstrate that CAI levels are an early indicator of jaundice.

Secondary Outcome Measures :
  1. CAI Elisa kit performance [ Time Frame: 10 days ]
    To determine if CAI immunoreactivity assays performed on urine samples could be adapted to simple ELISA-based kits

Biospecimen Retention:   Samples Without DNA
Urine samples

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Greater than 36 week gestation babies admitted to the neonatal unit

Inclusion Criteria:

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

Exclusion Criteria:

Babies with chromosomal abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05287607

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Contact: Hammad Khan, MBBS +447790030773 hammad.khan@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
University of Oxford
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Principal Investigator: Hammad Khan, MBBS Guy's and St Thomas' NHS Foundation Trust
Study Director: Pawel Swietach University of Oxford
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05287607    
Other Study ID Numbers: 261277
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: March 18, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD outside the study team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs