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Tests treatment safety and results for Hyperbilirubinemia, Neonatal Indirect
Official title The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
ClinicalTrials.gov ID: NCT07110987
What this study is testing
What is ursodeoxycholic acid (UDCA)?
ursodeoxycholic acid (UDCA) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for hyperbilirubinemia, neonatal indirect.
Also referred to as Ursodiol, UDCA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation. Eligible neonates will be randomly assigned to one of two groups: Group A: continuous triple phototherapy only Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 1
You may be able to join if
- Neonates with gestational age ≥ 34 weeks
- Appropriate for Gestational Age (AGA) infants
- Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
You likely can't join if
- Gestational age \< 34 weeks
- Small or Large for Gestational Age
- Direct (conjugated) hyperbilirubinemia \> 20% of total bilirubin
- Suspected or confirmed sepsis
- Neonates of diabetic mothers
- Presence of congenital or acquired liver disease
See the full eligibility criteria
- Neonates with gestational age ≥ 34 weeks
- Appropriate for Gestational Age (AGA) infants
- Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
- Gestational age \< 34 weeks
- Small or Large for Gestational Age
- Direct (conjugated) hyperbilirubinemia \> 20% of total bilirubin
- Suspected or confirmed sepsis
- Neonates of diabetic mothers
- Presence of congenital or acquired liver disease
- Receiving Total Parenteral Nutrition (TPN)
The study team makes the final eligibility decision.
Where it's taking place
- Latakia, Syria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 1 month. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Latakia, Syria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.