Comparing follow-up methods for neonatal jaundice prevention
Application of Two Different Follow-up Methods for Neonatal Jaundice in the Prevention of Severe Hyperbilirubinemia
This study is testing whether an online follow-up method or a traditional clinic visit is better for preventing severe jaundice in newborns and easier for parents to use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 0 Days to 16 Weeks |
| Sex | All |
| Sponsor | Guizhou Provincial People's Hospital Academic / other |
| Locations | 3 sites (Anshun, Guizhou and 2 other locations) |
| Trial ID | NCT06075290 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness and efficiency of two different follow-up methods for preventing severe hyperbilirubinemia in neonates. Parents can choose between an internet plus follow-up model and a conventional clinic follow-up method. After obtaining informed consent, the study will record various data points, including instances of severe hyperbilirubinemia and the duration of phototherapy. The goal is to determine which follow-up method is more effective and easier for parents to accept.
Who should consider this trial
Good fit: Ideal candidates include neonates with a gestational age of 28 weeks or more who exhibit skin yellowing but have stable vital signs.
Not a fit: Patients with direct bilirubin levels above 34mmol/L or those who have already developed bilirubin encephalopathy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve follow-up care for neonates with jaundice, potentially reducing the incidence of severe hyperbilirubinemia.
How similar studies have performed: While this approach is relatively novel, similar studies have shown that alternative follow-up methods can improve patient outcomes in other pediatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gestational age ≥ 28 weeks, corrected gestational age ≤ 44 weeks; 2. Presence of skin yellowing, percutaneous measurement of jaundice or serum bilirubin concentration less than the phototherapy warning value for the same gestational age and day age group; 3. The vital signs are stable and meet the discharge requirements; 4. Agree to participate in this project and sign an informed consent form; 5. Parents have a certain understanding ability to cooperate in this study; Exclusion Criteria: 1. Direct bilirubin ≥34mmol/L; 2. Increased hepatic enzyme level more than twice of normal value; 3. Those infants who have developed bilirubin encephalopathy or neurological damage due to other reasons before follow-up; 4. Unable to continue follow-up due to other diseases.
Where this trial is running
Anshun, Guizhou and 2 other locations
- People's Hospital of Anshun City Guizhou Province — Anshun, Guizhou, China (Not_yet_recruiting)
- The First Affiliated Hospital of Guizhou University of Chinese — Guiyang, Guizhou, China (Not_yet_recruiting)
- Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Rong Chen, doctor — Guizhou Provincial People's Hospital
- Study coordinator: Rong Chen, doctor
- Email: chenronggy@foxmail.com
- Phone: 18985180888
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.