Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Recruiting now · Phase 4

Conditions studied: Neonatal Hyperbilirubinemia

In brief

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.

Key facts

Study ID

NCT06517862

Run by

Amira Adel Fouly

People needed

80

Starts

2024-09-01

Expected to finish

2026-06-30

Last updated by the study team

2026-03-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals — Cairo, Cairo Governorate, Egypt (enrolling)

Full record on ClinicalTrials.gov

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