RecruitingPhase 4NCT06517862

Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia


Sponsor

Amira Adel Fouly

Enrollment

80 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 1 DayMax Age: 1 Month

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

DRUGZinc sulfate

Neonates will receive oral Zn sulfate solution in either low doses (10 mg/day) or high doses (20 mg/day) given twice daily.

DRUGUrsodeoxycholic acid

Neonates will receive oral UDCA solution at 10 mg/day given as 5 mg twice daily.


Locations(1)

Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

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NCT06517862