Status:

NOT_YET_RECRUITING

Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Lead Sponsor:

Amira Adel Fouly

Collaborating Sponsors:

Egyptian Chinese University

Ain Shams University

Conditions:

Neonatal Hyperbilirubinemia

Eligibility:

All Genders

1-1 years

Phase:

PHASE4

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 bi...

Detailed Description

Neonatal jaundice, or neonatal hyperbilirubinemia, is the most common medical issue in the first two weeks of life and is a frequent cause of prolonged hospitalization and readmission to the hospital ...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06517862

Start Date

September 1 2024

End Date

December 1 2024

Last Update

August 9 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

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

Cairo, Egypt