Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia

Launched by AMIRA ADEL FOULY · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe certain oral medications can be when used alongside phototherapy for treating neonatal hyperbilirubinemia, commonly known as jaundice in newborns. Jaundice is a condition where a baby’s skin and eyes turn yellow due to high levels of bilirubin, a substance produced when the body breaks down red blood cells. This trial is particularly important because jaundice is very common in newborns, especially in the first week of life, and can sometimes lead to longer hospital stays or readmissions.

To be eligible for this study, babies need to be at least 32 weeks old, able to eat normally, and diagnosed with a specific type of jaundice that requires phototherapy (light treatment) within their first week. However, babies with certain serious conditions or those who have had a specific blood treatment recently won't be included. If you decide to participate, your baby will receive the standard light treatment along with the study medication to see if it helps clear the jaundice more effectively and safely. This could potentially lead to shorter treatment times and fewer complications.

Gender

ALL

Eligibility 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.