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Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort

NCT06341582 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2700

Last updated 2024-04-02

No results posted yet for this study

Summary

The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc.

Conditions

  • Neonatal Jaundice
  • Neonatal Hyperbilirubinemia
  • Hemolysis Neonatal

Interventions

DIAGNOSTIC_TEST

End-tidal carbon monoxide-corrected (ETCOc)

Early postnatal ETCOc levels

Sponsors & Collaborators

  • Guangzhou Women and Children's Medical Center

    lead OTHER

Principal Investigators

  • Huayan Zhang, M.D. · Guangzhou Women and Children's Medical Center

Eligibility

Min Age
1 Hour
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341582 on ClinicalTrials.gov