Newborn Jaundice Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 1 month
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Neonatal Intensive Care Unit (NICU) of Ain Shams University Hospitals
RECRUITING
Cairo
Contact Information
Primary
Amira M. Fouly, Demonstrator
amira.mohamed@ecu.edu.eg
+20 102 303 3092
Backup
Dina K. Abou El Fadl, lecturer
Dkhaled@fue.edu.eg
+20 100 544 2855
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 80
Treatments
No_intervention: preterm: control
phototherapy only
Experimental: preterm: low dose of oral zinc sulfate
Neonates will receive oral Zn sulfate solution in low doses (10 mg/day) given as 5 mg twice daily.
Experimental: preterm: high dose of oral zinc sulfate
Neonates will receive oral Zn sulfate solution in a high dose (20 mg/day) given as 10 mg twice daily.
Experimental: preterm: low dose of oral UDCA
Neonates will receive oral UDCA solution at 10 mg/kg twice daily.
No_intervention: full-term: control
phototherapy only
Experimental: full-term: low dose of oral zinc sulfate
Neonates will receive oral Zn sulfate solution in low doses (10 mg/day) given as 5 mg twice daily.
Experimental: full-term: high dose of oral zinc sulfate
Neonates will receive oral Zn sulfate solution in a high dose (20 mg/day) given as 10 mg twice daily.
Experimental: full-term: low dose of oral UDCA
Neonates will receive oral UDCA solution at 10 mg/kg twice daily.
Sponsors
Collaborators: Egyptian Chinese University, Ain Shams University
Leads: Amira Adel Fouly

This content was sourced from clinicaltrials.gov