An interventional study of Phototherapy with placebo and Phototherapy with ursodeoxycholic acid in Hyperbilirubinemia Indirect, sponsored by Muhammad Aamir Latif. Completed at 1 site in Pakistan. Open to participants aged 3 Days to 28 Days. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Muhammad Aamir Latif · Not applicable, Interventional, and Treatment
There is limited local data on the efficacy of ursodeoxycholic acid combined with phototherapy. Therefore, the present study was planned to compare mean serum bilirubin levels in neonates with indirect hyperbilirubinemia receiving phototherapy alone with those receiving combination treatment with phototherapy and ursodeoxycholic acid.
Neonatal indirect hyperbilirubinemia is commonly managed with phototherapy, but some neonates may require prolonged treatment. Ursodeoxycholic acid may enhance bile flow and bilirubin elimination; however, evidence regarding its additional benefit with phototherapy, particularly in the local population, remains limited. Therefore, this randomized controlled trial will compare bilirubin reduction with phototherapy alone versus combination therapy. If effective, ursodeoxycholic acid may potentially shorten phototherapy duration and hospital stay and provide an additional treatment option for neonates with persistent hyperbilirubinemia.
Muhammad Aamir Latif is the lead sponsor of 57 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Patients received phototherapy and placebo.
Other: Phototherapy with placebo
Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day.
Drug: Phototherapy with ursodeoxycholic acid
Patients received phototherapy and placebo.
Drug page: Ursodeoxycholic Acid
Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day.
Mean serum bilirubin level
Mean serum bilirubin level measured 48 hours after initiation of treatment were compared between neonates receiving phototherapy alone and those receiving phototherapy combined with ursodeoxycholic acid.
Time frame: 48 hours after initiation of treatment
Plan to share: No — Data can be shared on a reasonable request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ursodeoxycholic Acid
Muhammad Aamir Latif