Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia (PREVENT) Cohort: a Multi-center Prospective Cohort Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 3 days
Healthy Volunteers: t
View:

• Infants who are born at gestational age ≥35 weeks and with a birth weight ≥2000 grams within 72 hours after birth

• Infants who are born at study centers

• Infants with the informed consent obtained from the parents or legal guardians

Locations
Other Locations
China
Dongguan Maternity and Child Healthcare Hospital
NOT_YET_RECRUITING
Dongguan
Foshan Shunde Women and Children Health Care Hospital
NOT_YET_RECRUITING
Foshan
Guangdong Maternity and Child Healthcare Hospital
NOT_YET_RECRUITING
Guangzhou
Guangzhou Women and Children's Medical Center
RECRUITING
Guangzhou
The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital
NOT_YET_RECRUITING
Guangzhou
The First affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Shenzhen Maternity and Child Healthcare Hospital
NOT_YET_RECRUITING
Shenzhen
Contact Information
Primary
Ge Yang, M.D.
geyang99@outlook.com
(86)020-38076329
Backup
Yuan Yuan, M.D., M.P.H.
yuan926@hotmail.com
(86)020-38076329
Time Frame
Start Date: 2023-12-11
Estimated Completion Date: 2025-11
Participants
Target number of participants: 2700
Treatments
Neonates with hemolytic hyperbilirubinemia
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.
Neonates without hemolytic hyperbilirubinemia
Neonates who have no neonatal hyperbilirubinemia.
Sponsors
Leads: Guangzhou Women and Children's Medical Center

This content was sourced from clinicaltrials.gov