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Hyperbilirubinemia Risk Evaluation and Management by ETCOc in Near-term and Term Chinese Neonates (HEME): A Randomized Controlled Clinical Trial

Prediction of neonatal hyperbilirubinemia risk using noninvasive techniques

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051476
Enrollment
Unknown
Registered
2021-09-24
Start date
2021-09-13
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperbilirubinemia of newborn

Interventions

Experimental group:Using ETCOc to identify the risk of hemolytic conditions, and combined to TCB to establish the threshold of phototherapy.
control group:Empirical assessment of hemolysis by pediatricians, and using TCB to establish the threshold of phototherapy.

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Newborns with gestational age >= 35 weeks and birth weight >=2000 grams; 2. TCB over 40 percentile was monitored within 72 hours after birth (according to Bhutani neonatal hour-bilirubin histogram); 3. Obtain informed parental consent.

Exclusion criteria

Exclusion criteria: 1.Hospitalized newborns who need respiratory support after birth (including oxygen therapy and ventilation); 2.The presence of severe or life-threatening congenital malformations (cardiovascular malformations, pulmonary malformations, chromosomal abnormalities); 3.The presence of nasal mucosa injury, posterior nostril atresia and Pilot sequence signs; 4.The mother has a history of smoking or passive smoking in the last trimester of pregnancy.

Design outcomes

Primary

MeasureTime frame
The rate of phototherapy within 7 day after birth;

Secondary

MeasureTime frame
postnatal hours when requiring phototherapy within 7 days after birth;TcB,TSB,ETCOc levels of the participants when requiring phototherapy within 7 days after birth;Maternal-fetal ABO incompatibility, ABO HDN or G6PD diagnoses the incidence of hemolytic disease;

Countries

China

Contacts

Public ContactYuan Yuan

Guangzhou Women and Children's Medical Center

Yuan926@hotmail.com+86 138 2602 3001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026