An observational study in Neonatal Jaundice, Neonatal Hyperbilirubinemia and Hemolysis Neonatal, sponsored by Guangzhou Women and Children's Medical Center. Recruiting at 7 sites in China. Open to participants aged 1 Hour to 72 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Guangzhou Women and Children's Medical Center · Observational
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.
Study design: this study is a multi-center, prospective observational cohort study on neonatal jaundice. Eligible participants will be enrolled in the well-baby nursery and neonatal intensive care units (NICU). Transcutaneous bilirubin and/or total serum bilirubin (TCB/TSB) will be measured as per clinical practice and simultaneous ETCOc (within time intervals ≤3 hours) will be monitored until (1) the newborn is discharged with the mother, or (2) until 72 hours after birth or (3) requiring the treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) (whichever comes first). For infants who do not require treatments for hyperbilirubinemia (phototherapy and/or exchange transfusion) during the stay in well-baby nursery or in the NICU within 72 hours after birth, they will be followed up via telephone or outpatient clinic visits during the first 14 days of life (DOL).
The primary outcome is the first occurrence of hemolytic hyperbilirubinemia requiring treatments within DOL14. For participants who have the primary outcome occurred within DOL14, follow-up calls/visits will continue until DOL28 to record the readmissions due to hyperbilirubinemia within 28 DOL . The secondary outcomes are 1) the incidence of hemolytic diseases of newborns; 2) characteristics of treatment for hemolytic hyperbilirubinemia: postnatal age when requiring the treatment, levels of TCB/TSB/ETCOc during hospitalization, length of stay, length of phototherapy, courses of phototherapy, exchange of transfusion, the use of intravenous immunoglobulin; 3) characteristics of readmission for hyperbilirubinemia in 28 DOL: readmission for hyperbilirubinemia in 28 DOL, postnatal age when readmitted, TCB/TSB levels when readmitted
Exposures and measurements:
Covariates and characteristics: covariates will be collected including maternal and prenatal history (e.g., mother's blood type [ABO and Rh type], G6PD deficiency status, etc.), family history (e.g., history of hemolytic diseases in the previous newborn, history of NHB treatment in the previous newborn, etc.). Clinical characteristics include demographic characteristics (e.g., gestational age, birth weight), infant's blood type (ABO and Rh type), the status of G6PD deficiency,ABO incompatibility and hemolysis, feeding history and other risk factors (e.g., early discharge after birth, excessive weight loss and the presence of hematoma) as well as data related to the primary and secondary outcomes.
For analysis, this study will examine the association between early postnatal ETCOc and the incidence of hemolytic hyperbilirubinemia, and the relation of ETCOc levels with the characteristics of treatments for hyperbilirubinemia.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 2,700 is above the median of 405 across 27 observational studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Guangzhou Women and Children's Medical Center is the lead sponsor of 58 studies on the registry; 30 are open to participants now.
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The eligible study population will be screened in the well-baby nursery or the neonatal intensive care unit (NICU).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neonates who are diagnosed as neonatal hyperbilirubinemia and hemolytic diseases of newborns. Neonatal hyperbilirubinemia is defined as the total serum bilirubin (TSB) reaching or exceeding the thresholds in aligned with the 2004 American Academy of Pediatrics (AAP) guidelines. Hemolytic diseases of newborns is defined as a diagnosis of ABO hemolytic diseases of newborns and/or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)
Neonates who have no neonatal hyperbilirubinemia.
Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)
Early postnatal ETCOc levels
The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL)
The incidence of neonatal hyperbilirubinemia and hemolytic diseases of newborns
Time frame: Within 14 days of life (DOL)
The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL)
The diagnosis of neonatal hyperbilirubinemia as per the 2004 AAP guidelines
Time frame: Within 14 days of life (DOL)
The incidence of hemolytic diseases of newborns within 14 days of life (DOL)
The diagnosis of ABO hemolytic diseases of newborns and/or G6PD deficiency
Time frame: Within 14 days of life (DOL)
The rate of readmission due to neonatal hyperbilirubinemia within 28 days of life (DOL)
The readmission rate due to neonatal hyperbilirubinemia for neonates who are previously admitted because of neonatal hyperbilirubinemia within 28 DOL
Time frame: Within 28 days of life (DOL)
Plan to share: No — There is not a plan to make individual participant data available.
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Nov 2025, 23 months after the start.
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Guangzhou Women and Children's Medical Center