Using ETCOc to predict neonatal jaundice in newborns
Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia (PREVENT) Cohort: a Multi-center Prospective Cohort Study
This study is testing if measuring carbon monoxide levels in newborns can help predict which babies are at risk for jaundice that needs treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Ages | 1 Hour to 72 Hours |
| Sex | All |
| Sponsor | Guangzhou Women and Children's Medical Center Academic / other |
| Locations | 7 sites (Dongguan, Guangdong and 6 other locations) |
| Trial ID | NCT06341582 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the relationship between end-tidal carbon monoxide-corrected (ETCOc) levels and the risk of hemolytic hyperbilirubinemia in newborns. Eligible infants, born at gestational age of 35 weeks or more and weighing at least 2000 grams, will have their ETCOc monitored alongside bilirubin levels during their stay in well-baby nurseries or neonatal intensive care units. The study will track the occurrence of hyperbilirubinemia requiring treatment within the first 14 days of life and follow up on those who do not require treatment for additional insights. The goal is to establish ETCOc as a predictive marker for early intervention in at-risk infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at 35 weeks gestation or later, weighing at least 2000 grams, and who are within 72 hours of birth.
Not a fit: Patients who may not benefit include those requiring immediate respiratory support after birth or those with significant congenital anomalies.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and treatment of neonatal hyperbilirubinemia, potentially reducing complications in newborns.
How similar studies have performed: While there is limited clinical evidence regarding the use of ETCOc for this purpose, the approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Immediate requirement of respiratory support after birth (e.g., mechanical ventilation, nasal high-flow cannula oxygen therapy) * Mothers who have active tobacco smoking or continuous environmental tobacco exposure during pregnancy * Major congenital anomalies (e.g., cardiac or lung abnormalities, lethal chromosomal defects) * The presence of injury of nasal mucosa, choanal atresia or Pierre Robin Sequence
Where this trial is running
Dongguan, Guangdong and 6 other locations
- Dongguan Maternity and Child Healthcare Hospital — Dongguan, Guangdong, China (Not_yet_recruiting)
- Foshan Shunde Women and Children Health Care Hospital — Foshan, Guangdong, China (Not_yet_recruiting)
- Guangdong Maternity and Child Healthcare Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- The First affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
- Shenzhen Maternity and Child Healthcare Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Huayan Zhang, M.D. — Guangzhou Women and Children's Medical Center
- Study coordinator: Ge Yang, M.D.
- Email: geyang99@outlook.com
- Phone: (86)020-38076329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.