Hyperbilirubinemia IndirectNCT07867366
Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy
A study testing Phototherapy with ursodeoxycholic acid in people with Hyperbilirubinemia Indirect, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 28 days
- Conditions the study is for
- Hyperbilirubinemia Indirect
- What is being tested?
- Phototherapy with ursodeoxycholic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates of either sex
- Age 3-28 days
- Gestational age 38-41 weeks
- Birth weight 2.5-4.0 kg
- Total serum bilirubin level 14-20 mg/dL and direct bilirubin level <2 mg/dL
Who cannot join
- Neonates with ABO incompatibility or Rhesus (Rh) incompatibility
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Septicemia
- Conditions causing hyperbilirubinemia, including Crigler-Najjar syndrome, Gilbert syndrome, hypothyroidism, hyperthyroidism, or liver disease
- Infants of diabetic mothers
- Major congenital anomalies
- Previous exposure to phototherapy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital/D.G. Khan Medical College
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Hyperbilirubinemia Indirect
- Being tested
- Phototherapy with placebo, Phototherapy with ursodeoxycholic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phototherapy with placeboOther
Patients received phototherapy and placebo.
Phototherapy with ursodeoxycholic acidDrug
Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy-Group | Experimental | Patients received phototherapy and placebo. Receives: Other: Phototherapy with placebo |
| Ursodeoxycholic acid-Group | Experimental | Patients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day. Receives: Drug: Phototherapy with ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Feb 2026
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia IndirectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Nusrat Hussain, FCPS, Principal investigator, Allama Iqbal Teaching Hospital/D. G. Khan Medical CollegeAyaz Ali, FCPS, Principal investigator, Allama Iqbal Teaching Hospital/DG Khan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867366
- Sponsor's protocol ID
- Dr-Nusrat-DGK
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates Treated With Phototherapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867366
- Acronym / sponsor ID
- Dr-Nusrat-DGK
- Conditions
- Hyperbilirubinemia Indirect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy-Group | Experimental | Other: Phototherapy with placeboPatients received phototherapy and placebo. |
| Ursodeoxycholic acid-Group | Experimental | Drug: Phototherapy with ursodeoxycholic acidPatients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day. |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Neonates of either sex
- Age 3-28 days
- Gestational age 38-41 weeks
- Birth weight 2.5-4.0 kg
- Total serum bilirubin level 14-20 mg/dL and direct bilirubin level <2 mg/dL
Key exclusion criteria (7 listed)
- Neonates with ABO incompatibility or Rhesus (Rh) incompatibility
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Septicemia
- Conditions causing hyperbilirubinemia, including Crigler-Najjar syndrome, Gilbert syndrome, hypothyroidism, hyperthyroidism, or liver disease
- Infants of diabetic mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phototherapy with placeboPatients received phototherapy and placebo. | Other | Phototherapy-Group |
| Phototherapy with ursodeoxycholic acidPatients received phototherapy along with ursodeoxycholic acid in a dose of 10mg/kg body weight/day. | Drug | Ursodeoxycholic acid-Group |
Primary outcome
Mean serum bilirubin level
Time frame: 48 hours after initiation of treatment
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
Related trials for Hyperbilirubinemia Indirect
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COMPARISON OF ZINC AND PROBIOTICS ON NEONATES WITH INDIRECT HYPERBILIRUBINEMIA UNDERGOING PHOTOTHERAPY
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nusrat Hussain, FCPS principal investigator
Allama Iqbal Teaching Hospital/D. G. Khan Medical College
Ayaz Ali, FCPS principal investigator
Allama Iqbal Teaching Hospital/DG Khan Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy with ursodeoxycholic acid in people with Hyperbilirubinemia Indirect, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean serum bilirubin level (time frame: 48 hours after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.