Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341582
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-12-24
Brief Title:
Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort
Sponsor:
Guangzhou Women and Childrens Medical Center
Organization:
Guangzhou Women and Childrens Medical Center
Study Overview
Official Title:
Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia PREVENT Cohort a Multi-center Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT
Brief 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
Detailed Description:
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 andor total serum bilirubin TCBTSB 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 andor exchange transfusion whichever comes first For infants who do not require treatments for hyperbilirubinemia phototherapy andor 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 callsvisits 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 TCBTSBETCOc 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 TCBTSB levels when readmitted
Exposures and measurements
1 Early postnatal 72 hours ETCOc levels
2 ETCOc levels within 14 days after birth
3 ETCOc levels before each phototherapy andor exchange transfusion treatment
4 ETCOc levels when stopping phototherapy andor exchange transfusion treatment
Covariates and characteristics covariates will be collected including maternal and prenatal history eg mothers blood type ABO and Rh type G6PD deficiency status etc family history eg history of hemolytic diseases in the previous newborn history of NHB treatment in the previous newborn etc Clinical characteristics include demographic characteristics eg gestational age birth weight infants blood type ABO and Rh type the status of G6PD deficiencyABO incompatibility and hemolysis feeding history and other risk factors eg 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
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 callsvisits 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 TCBTSBETCOc 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 TCBTSB levels when readmitted
Exposures and measurements
1 Early postnatal 72 hours ETCOc levels
2 ETCOc levels within 14 days after birth
3 ETCOc levels before each phototherapy andor exchange transfusion treatment
4 ETCOc levels when stopping phototherapy andor exchange transfusion treatment
Covariates and characteristics covariates will be collected including maternal and prenatal history eg mothers blood type ABO and Rh type G6PD deficiency status etc family history eg history of hemolytic diseases in the previous newborn history of NHB treatment in the previous newborn etc Clinical characteristics include demographic characteristics eg gestational age birth weight infants blood type ABO and Rh type the status of G6PD deficiencyABO incompatibility and hemolysis feeding history and other risk factors eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None