protocolSection identificationModule nctId: NCT06341582, orgStudyIdInfo id: 2023-10-14, briefTitle: Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort, acronym: PREVENT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-11, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Guangzhou Women and Children's Medical Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Neonatal Jaundice, conditions: Neonatal Hyperbilirubinemia, conditions: Hemolysis Neonatal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2700, type: ESTIMATED, armsInterventionsModule interventions name: End-tidal carbon monoxide-corrected (ETCOc), outcomesModule primaryOutcomes measure: The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL), secondaryOutcomes measure: The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL), secondaryOutcomes measure: The incidence of hemolytic diseases of newborns within 14 days of life (DOL), otherOutcomes measure: The rate of readmission due to neonatal hyperbilirubinemia within 28 days of life (DOL), eligibilityModule sex: ALL, minimumAge: 1 Hour, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: Dongguan Maternity and Child Healthcare Hospital, status: NOT_YET_RECRUITING, city: Dongguan, state: Guangdong, zip: 523700, country: China, contacts name: Minxu Li, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.01797, lon: 113.74866, locations facility: Foshan Shunde Women and Children Health Care Hospital, status: NOT_YET_RECRUITING, city: Foshan, state: Guangdong, zip: 528300, country: China, contacts name: Runzhong Huang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02677, lon: 113.13148, locations facility: Guangdong Maternity and Child Healthcare Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510010, country: China, contacts name: Chuan Nie, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First affiliated Hospital, Sun Yat-sen University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Muxue Yu, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Guangzhou Women and Children's Medical Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510623, country: China, contacts name: Ge Yang, M.D., role: CONTACT, phone: (86)020-38076329, email: geyang99@outlook.com, contacts name: Huayan Zhang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510632, country: China, contacts name: Bingxiao Li, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Shasha Han, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Maternity and Child Healthcare Hospital, status: NOT_YET_RECRUITING, city: Shenzhen, state: Guangdong, zip: 518000, country: China, contacts name: Chuanzhong Yang, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False