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Search / Trial NCT06341582

Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort

Launched by GUANGZHOU WOMEN AND CHILDREN'S MEDICAL CENTER · Mar 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Neonatal Hyperbilirubinemia Hemolysis Neonatal End Tidal Carbon Monoxide Corrected (Etc Oc)

ClinConnect Summary

The clinical trial titled "Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort" is studying a condition known as neonatal jaundice, which occurs when newborns have high levels of bilirubin in their blood. This can happen especially in babies with a condition called hemolytic disease of newborns (HDN). Researchers believe that measuring a specific type of carbon monoxide in the breath, called ETCOc, can help predict which infants might develop severe jaundice that requires treatment within the first two weeks after birth. By understanding this relationship, the study hopes to improve early detection and care for at-risk infants.

To participate in the trial, infants must be born at least 35 weeks gestational age and weigh at least 2000 grams. They should be born at the study centers and have parental consent. However, infants who need immediate breathing support at birth, have certain health issues, or whose mothers were smoking during pregnancy are not eligible. Families who choose to participate will be contributing to important research that could help doctors better manage jaundice in newborns, potentially improving outcomes for many babies.

Gender

ALL

Eligibility 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

About Guangzhou Women And Children's Medical Center

Guangzhou Women and Children's Medical Center is a leading healthcare institution dedicated to advancing the health and well-being of women and children through comprehensive medical services, research, and education. As a prominent clinical trial sponsor, the center focuses on innovative studies aimed at improving maternal and pediatric health outcomes. With a commitment to evidence-based practices and collaborative partnerships, the center strives to contribute to the global body of medical knowledge while ensuring the highest standards of patient care and ethical research practices.

Locations

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Shenzhen, Guangdong, China

Dongguan, Guangdong, China

Foshan, Guangdong, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Huayan Zhang, M.D.

Principal Investigator

Guangzhou Women and Children's Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported