Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia (NCT06517862) | Clinical Trial Compass
RecruitingPhase 4
Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia
Egypt80 participantsStarted 2024-09-01
Plain-language summary
Neonatal jaundice, or neonatal hyperbilirubinemia, is a common medical issue in the first two weeks of life, causing prolonged hospitalization and readmissions. It results from elevated total serum bilirubin (TSB) and is manifested as yellowish discoloration of the skin, sclera, and mucous membrane. Clinical jaundice appears in about 60% of term neonates and 80% of preterm infants within the first week of life. Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mg/dL/day or 0.2 mg/dL/hour, or when jaundice lasts longer than two to three weeks in full-term infants. In preterm infants, unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain. Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions. However, phototherapy has both immediate and long-term side effects, and it can only decrease accumulated UCB but does not prevent its accumulation. There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance, decrease phototherapy duration, and decrease exchange transfusion rate.
Who can participate
Age range
1 Day – 1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* neonates with both genders
* neonates with gestational age ≥ 32 weeks
* neonates who can tolerate enteral feeding
* diagnosed with unconjugated non-hemolytic hyperbilirubinemia
* Phototherapy is required within the first week of life.
Exclusion Criteria:
* Neonates with seizures, hydrops fetalis, hypoxic-ischemic encephalopathy, or major congenital anomalies
* Neonates who have had an exchange transfusion within 24 hours
* neonates have evidence of hemolytic causes of jaundice (e.g., ABO and RH
* incompatibility, glucose 6-phosphate dehydrogenase deficiency)
* neonates who have reported hypersensitivity to zinc sulfate or ursodeoxycholic acid.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.