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The efficacy of Ursodeoxycholic Acid on Unconjugated Hyperbilirubinemia in Term Neonates Undergoing Phototherapy

The Impact of Ursodeoxycholic Acid on Unconjugated Hyperbilirubinemia in Term Neonates Undergoing Phototherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260412001
Enrollment
76
Registered
2026-04-12
Start date
2024-07-02
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unconjugated hyperbilirubinemia (neonatal jaundice) in term neonates. unconjugated hyperbilirubinemia.

Interventions

Control group only receive routine care and phototherapy ,It receive phototherapy plus UDCA 10 mg/kg/day orally in two divided doses.
No Intervention No treatment,Experimental Drug
Control,Interventional group

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
37 Weeks to 41 Weeks

Inclusion criteria

Inclusion criteria: 1.Gestational age greater than 37 to 41, 2.birth weight of 2500 to 4000gram, 3.exclusive breast feed having total bilirubin of 12 to 20 mg/dl and direct bilirubin level less than 2mg/dl.

Exclusion criteria

Exclusion criteria: 1.Neonates were excluded if there was ABO and Rh incompatibility. 2.glucose 6 phosphate dehydrogenase deficiency (G6PDd), 3.history of any neurological or chronic diseases. 4.sepsis, 5.diseases leading to hyperbilirubinemia (e.g. A. Crigler- Najjar and Gilbert's syndromes, B.hypothyroidism, c.liver disease, 6.history of maternal diabetes, 7.parental dissatisfaction.

Design outcomes

Primary

MeasureTime frame
Total serum bilirubin 72 hours It will be measured by Bilirubin Analyzer, an APEL BR-5200P Bilirubinometer by spectrophotometric method.

Secondary

MeasureTime frame
Material-specific wear and surface characteristics 1, 6, and 12 months Assessed using intraoral scanning (iTero) and clinical inspection

Countries

Pakistan

Contacts

Public ContactSheikh Ali Ajmal

Sheikh zayed hospital Rahim yar khan

shaliahmadajmal@ymail.com03356829387

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026