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Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

NCT06517862 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

  • Neonatal Hyperbilirubinemia

Interventions

DRUG

Zinc sulfate

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

DRUG

Ursodeoxycholic acid

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

Sponsors & Collaborators

  • Egyptian Chinese University

    collaborator OTHER

  • Ain Shams University

    collaborator OTHER

  • Amira Adel Fouly

    lead OTHER

Principal Investigators

  • Ehab R. Bendas, professor · Future University in Egypt

  • Yasmin A. Farid · Ain Shams University

  • Dina K. Abou El Fadl, Lecturer · Future University in Egypt

  • Sarah S. Hesham, Lecturer · Egyptian Chinese University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-06-01
Completion
2026-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517862 on ClinicalTrials.gov