Oral zinc or ursodeoxycholic acid with phototherapy for newborn jaundice
Efficacy and Safety of Oral Zinc Sulphate and Ursodeoxycholic Acid as Adjuvants to Phototherapy in Management of Neonatal Non-Hemolytic Unconjugated Hyperbilirubinemia
This will test whether adding oral zinc sulfate or ursodeoxycholic acid to phototherapy helps newborns (≥32 weeks) with non‑hemolytic jaundice lower their bilirubin faster and safely.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 1 Day to 1 Month |
| Sex | All |
| Sponsor | Future University in Egypt Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT06517862 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional trial gives newborns with unconjugated non‑hemolytic hyperbilirubinemia standard phototherapy plus an oral adjuvant (either zinc sulfate or ursodeoxycholic acid) while tracking outcomes. Eligible neonates are ≥32 weeks gestation, tolerating enteral feeds, and requiring phototherapy; key exclusions include hemolytic jaundice, recent exchange transfusion, seizures, hydrops, hypoxic‑ischemic encephalopathy, major anomalies, or drug hypersensitivity. Investigators will monitor total serum bilirubin, duration of phototherapy, need for exchange transfusion, and adverse events to determine safety and whether bilirubin declines more quickly. The trial is carried out at the Neonatal Intensive Care Unit of Ain Shams University Hospitals in Cairo.
Who should consider this trial
Good fit: Newborns born at ≥32 weeks with unconjugated non‑hemolytic jaundice who require phototherapy and can tolerate enteral feeding are the intended participants.
Not a fit: Infants with hemolytic causes of jaundice, major neonatal complications (seizures, hydrops fetalis, hypoxic‑ischemic encephalopathy), prior exchange transfusion within 24 hours, known allergy to the study drugs, or gestational age under 32 weeks are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, adding these oral drugs could shorten phototherapy time, speed bilirubin reduction, and lower the need for exchange transfusion or extended hospital stays.
How similar studies have performed: Some small clinical studies and biological rationale suggest zinc or ursodeoxycholic acid might reduce enterohepatic bilirubin recycling or speed bilirubin decline, but overall clinical evidence is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo, Cairo Governorate
- Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Amira M. Fouly, Demonstrator
- Email: amira.mohamed@ecu.edu.eg
- Phone: +20 102 303 3092
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.