Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

NCT06517862 | Recruiting Phase 4

• 1 other identifier: REC-FPFUE-31/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neonatal hyperbilirubinemia; Phototherapy; exchange transfusion; Zinc sulfate; Ursodeoxycholic acid

Outcome Measures

Primary Outcomes (2)

• serum bilirubin level.

  Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on serum bilirubin levels during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia.

  10 days

• duration of phototherapy needed.

  Assessing the effect of oral administration of zinc sulfate (at low and high doses) and ursodeoxycholic acid on the duration of phototherapy during the treatment of neonatal non-hemolytic unconjugated hyperbilirubinemia.

  10 days

Secondary Outcomes (3)

• monitoring adverse effects

  10 days

• serum zinc level

  10 days

• length of NICU stay.

  10 days

Study Arms (8)

preterm: control

NO INTERVENTION

phototherapy only

preterm: low dose of oral zinc sulfate

EXPERIMENTAL

Neonates will receive oral Zn sulfate solution in low doses (10 mg/day) given as 5 mg twice daily.

Drug: Zinc sulfate

preterm: high dose of oral zinc sulfate

EXPERIMENTAL

Neonates will receive oral Zn sulfate solution in a high dose (20 mg/day) given as 10 mg twice daily.

Drug: Zinc sulfate

preterm: low dose of oral UDCA

EXPERIMENTAL

Neonates will receive oral UDCA solution at 10 mg/kg twice daily.

Drug: Ursodeoxycholic acid

full-term: control

NO INTERVENTION

phototherapy only

full-term: low dose of oral zinc sulfate

EXPERIMENTAL

Neonates will receive oral Zn sulfate solution in low doses (10 mg/day) given as 5 mg twice daily.

Drug: Zinc sulfate

full-term: high dose of oral zinc sulfate

EXPERIMENTAL

Neonates will receive oral Zn sulfate solution in a high dose (20 mg/day) given as 10 mg twice daily.

Drug: Zinc sulfate

full-term: low dose of oral UDCA

EXPERIMENTAL

Neonates will receive oral UDCA solution at 10 mg/kg twice daily.

Drug: Ursodeoxycholic acid

Interventions

Zinc sulfate DRUG

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

Also known as: zinc origin

full-term: high dose of oral zinc sulfate; full-term: low dose of oral zinc sulfate; preterm: high dose of oral zinc sulfate; preterm: low dose of oral zinc sulfate

Ursodeoxycholic acid DRUG

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

Also known as: Livagoal

full-term: low dose of oral UDCA; preterm: low dose of oral UDCA

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Amira Adel Fouly: lead
• Egyptian Chinese University: collaborator
• Ain Shams University: collaborator

Study Sites (1)

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

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Zinc Sulfate; Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Ehab R. Bendas, professor

  Future University in Egypt

  STUDY DIRECTOR

• Yasmin A. Farid

  Ain Shams University

  STUDY DIRECTOR

• Dina K. Abou El Fadl, Lecturer

  Future University in Egypt

  STUDY DIRECTOR

• Sarah S. Hesham, Lecturer

  Egyptian Chinese University

  STUDY DIRECTOR

Central Study Contacts

Amira M. Fouly, Demonstrator

CONTACT

+20 102 303 3092; amira.mohamed@ecu.edu.eg

Dina K. Abou El Fadl, lecturer

CONTACT

+20 100 544 2855; Dkhaled@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: 8 arms (Full term Control, Full term Low Dose Zinc Sulphate, Full term High Dose Zinc Sulphate, Full term UDCA -- Preterm Control, Preterm Low Dose Zinc Sulphate, Preterm High Dose Zinc Sulphate, Preterm UDCA)

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)