Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort

NCT06341582 | Recruiting

• 1 other identifier: 2023-10-14
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 7

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.

Conditions

Neonatal Jaundice; Neonatal Hyperbilirubinemia; Hemolysis Neonatal

Keywords

Neonatal Hyperbilirubinemia; Hemolysis Neonatal; End-tidal carbon monoxide-corrected (ETCOc)

Outcome Measures

Primary Outcomes (1)

• The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL)

  The incidence of neonatal hyperbilirubinemia and hemolytic diseases of newborns

  Within 14 days of life (DOL)

Secondary Outcomes (2)

• The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL)

  Within 14 days of life (DOL)

• The incidence of hemolytic diseases of newborns within 14 days of life (DOL)

  Within 14 days of life (DOL)

Other Outcomes (1)

• The rate of readmission due to neonatal hyperbilirubinemia within 28 days of life (DOL)

  Within 28 days of life (DOL)

Study Arms (2)

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.

Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)

Neonates without hemolytic hyperbilirubinemia

Neonates who have no neonatal hyperbilirubinemia.

Diagnostic Test: End-tidal carbon monoxide-corrected (ETCOc)

Interventions

End-tidal carbon monoxide-corrected (ETCOc) DIAGNOSTIC_TEST

Early postnatal ETCOc levels

Neonates with hemolytic hyperbilirubinemia; Neonates without hemolytic hyperbilirubinemia

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The eligible study population will be screened in the well-baby nursery or the neonatal intensive care unit (NICU).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead

Study Sites (7)

Dongguan Maternity and Child Healthcare Hospital

Dongguan, Guangdong, 523700, China

NOT YET RECRUITING

Foshan Shunde Women and Children Health Care Hospital

Foshan, Guangdong, 528300, China

NOT YET RECRUITING

Guangdong Maternity and Child Healthcare Hospital

Guangzhou, Guangdong, 510010, China

NOT YET RECRUITING

The First affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

RECRUITING

The First Affiliated Hospital of Jinan University, Guangzhou Overseas Chinese Hospital

Guangzhou, Guangdong, 510632, China

NOT YET RECRUITING

Shenzhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, 518000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huayan Zhang, M.D.

  Guangzhou Women and Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ge Yang, M.D.

CONTACT

(86)020-38076329; geyang99@outlook.com

Yuan Yuan, M.D., M.P.H.

CONTACT

(86)020-38076329; yuan926@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division Chief

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: April 2, 2024
• Study Start: December 11, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)