Determining safe levels to stop phototherapy for newborn jaundice
Safe Threshold to Discontinue Phototherapy in Term and Late Preterm Infant With Hemolytic Disease of Newborn: A Randomized Controlled Trial
This study is testing if stopping light treatment for jaundice in newborns at a lower level is safer and helps prevent a return of high bilirubin levels compared to stopping at a higher level.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 1 Hour to 14 Days |
| Sex | All |
| Sponsor | Ministry of Health, Saudi Arabia Government |
| Locations | 1 site (Madinah) |
| Trial ID | NCT04218318 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a lower threshold for discontinuing phototherapy can reduce the rates of rebound hyperbilirubinemia in term and late preterm neonates suffering from hemolytic disease of the newborn. Participants will be divided into two groups: one will stop phototherapy at a higher threshold, while the other will stop at a lower threshold. The study aims to compare the safety and effectiveness of these two approaches in managing neonatal jaundice. The intervention involves administering phototherapy based on established guidelines and monitoring bilirubin levels closely.
Who should consider this trial
Good fit: Ideal candidates include healthy term and late-preterm neonates over 35 weeks gestation diagnosed with hemolytic disease of the newborn.
Not a fit: Patients with major congenital abnormalities, surgical problems, direct hyperbilirubinemia, or sepsis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer management of jaundice in newborns, reducing the risk of rebound hyperbilirubinemia.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a potential novel contribution to the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy term and late-preterm neonates more than or equal 35 weeks gestation with hemolytic disease of newborn will be included. Enrolled infants should have evidence of hemolysis as defined by any of the following criteria: 1. positive DAT and blood group iso-immunization (ABO / RH incompatibility);and /or 2. HGB decline by 2g/dl within 24hour. Exclusion Criteria: * Major congenital abnormalities, * Surgical problems, * Direct hyperbilirubinemia * Sepsis
Where this trial is running
Madinah
- Madinah maternity and children's hospital — Madinah, Saudi Arabia (Recruiting)
Study contacts
- Principal investigator: Fatimah S Alhazmi, MD — Ministry of Health, Saudi Arabia
- Study coordinator: Fatimah S Alhazmi, MD
- Email: f.alhazmi@hotmail.com
- Phone: 00 966 54 0564141
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.