Neonatal CholestasisNCT06628726
Liver Biopsy in Diagnosis Neonatal Jaundice
A study testing Liver biopsy in people with Neonatal Cholestasis and Neonatal Jaundice, run by Assiut University.
Trial summary
1. Identification and characterization of histopathological features of liver in cases of PNJ. 2. Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ. 3. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Neonatal Cholestasis, Neonatal Jaundice
- What is being tested?
- Liver biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to Dec 2025
- 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 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All cases presented with persistent neonatal jaundice in the first year of life in 5 years interval (2019-2023), received at Surgical Pathology Laboratory at Assiut University Hospitals, Egypt.
Who cannot join
- Patients older than one year.
- Patients who underwent liver biopsy in the same age group but were not diagnosed as Persistent Neonatal Jaundice.
- Patients with deficient clinical data.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes
- Identification and characterization of histopathological features of liver in cases of PNJ.
- Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ.
- Evaluation of role of liver biopsy as a diagnostic tool in conjunction with clinical and laboratory findings.
Read the detailed description
Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide.
In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively.
It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis.
Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient.
The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.
- Conditions
- Neonatal Cholestasis, Neonatal Jaundice
- Being tested
- Liver biopsy
- Keywords
- liver biopsy in neonatal jaundice, Neonatal Cholestasis, liver biopsy
- Medical subject headings
- Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyDiagnostic test
Also called Liver wedge biopsy, Liver core biopsy, Liver incisional biopsy
surgical biopsy from liver
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Experimental | Neonates with persistent neonatal jaundice underwent liver biopsy Receives: Diagnostic Test: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the key histopathological features in liver biopsy
Identification of the key histopathological features in liver biopsy that aid in differentiation intra-hepatic and extra-hepatic causes of persistent neonatal jaundice (PNJ).
Measured: baseline
Secondary outcomes (1)
Evaluation of significance of liver biopsy as a diagnostic tool
Evaluation of significance of liver biopsy as a diagnostic tool with clinical and laboratory findings in detection of persistent neonatal jaundice (PNJ) causes.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal CholestasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Hassan Fouad Hassan, Assiut University
- Investigators
- Moemen M Hafez, M.D., Study director, Faculty of Medicine, Assiut University, Assiut, EgyptAbeer M Refaiy, M.D., Study director, Faculty of Medicine, Assiut University, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628726
- Sponsor's protocol ID
- biopsy role neonatal jaundice
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansour E, Eissa AN, Nofal LM, Kharboush I, Reda AA. Morbidity and mortality of low-birth-weight infants in Egypt. East Mediterr Health J. 2005 Jul;11(4):723-31.
PubMed 16700389Fawaz R, Baumann U, Ekong U, Fischler B, Hadzic N, Mack CL, McLin VA, Molleston JP, Neimark E, Ng VL, Karpen SJ. Guideline for the Evaluation of Cholestatic Jaundice in Infants: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):154-168. doi: 10.1097/MPG.0000000000001334.
PubMed 27429428Ali KM, Zalata KR, Barakat T, Elzeiny SM. Pathologic approach to Neonatal cholestasis with a simple scoring system for biliary atresia. Virchows Arch. 2024 Jan;484(1):93-102. doi: 10.1007/s00428-023-03704-5. Epub 2023 Nov 27.
PubMed 38008855
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Liver Biopsy As a Diagnostic Tool for Neonatal Jaundice Causes
- ClinicalTrials.gov ID
- NCT06628726
- Acronym / sponsor ID
- biopsy role neonatal jaundice
- Conditions
- Neonatal Cholestasis, Neonatal Jaundice
- Keywords
- liver biopsy in neonatal jaundice, Neonatal Cholestasis, liver biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (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.
- Identification and characterization of histopathological features of liver in cases of PNJ.
- Assessment of key histological features in liver biopsy as diagnostic parameters in differentiating intra-hepatic and extra-hepatic causes of PNJ.
- Evaluation of role of liver biopsy as a diagnostic tool in conjunction with clinical and laboratory findings.
Detailed description
Neonatal cholestasis (NC) is described as an early-life defect in bile production or flow that causes the liver to retain biliary substances. Persistent Neonatal Jaundice (PNJ) is the presence of variable degrees of jaundice, choluria and hypocholic or acholic stools for more than 10 days during early months of life. The rate of neonatal cholestasis is estimated to be 1 per 2,500 live births worldwide.
In Egypt, about 20.4% of full-term newborns develop jaundice yearly. Extrahepatic cholestasis(EHC) and intrahepatic cholestasis(IHC) are the two main causes of persistent neonatal jaundice. This division is according to the presence or absence of extrahepatic obstruction to bile flow. Biliary atresia(BA) and idiopathic neonatal hepatitis(INH) are the most frequent etiologies for EHC and IHC respectively.
It is critical to identify the underlying cause of PNJ in order to start the right surgical or medicinal treatment. Early surgical referral is necessary in biliary atresia(BA) to increase success rates. In the case of treatable metabolic diseases, a prompt diagnosis justifies prompt, targeted therapy and a better prognosis.
Despite the development of new diagnostic means and advances in imaging techniques, non-invasive biomarkers and genomic studies, a liver biopsy done at the right time is still an important tool to evaluate and diagnose patients with cholestasis, as it will help to decide the etiology, the prognosis and eventually the treatment of the patient.
The evaluation of liver biopsies in infantile cholestasis disorders is crucial as the histologic features of many of these disorders may overlap and vary with age.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | Experimental | Diagnostic Test: Liver biopsyNeonates with persistent neonatal jaundice underwent liver biopsy |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All cases presented with persistent neonatal jaundice in the first year of life in 5 years interval (2019-2023), received at Surgical Pathology Laboratory at Assiut University Hospitals, Egypt.
Key exclusion criteria (3 listed)
- Patients older than one year.
- Patients who underwent liver biopsy in the same age group but were not diagnosed as Persistent Neonatal Jaundice.
- Patients with deficient clinical data.
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 |
|---|---|---|
| Liver biopsyAlso: Liver wedge biopsy, Liver core biopsy, Liver incisional biopsysurgical biopsy from liver | Diagnostic test | Neonates |
Primary outcome
Identification of the key histopathological features in liver biopsy
Time frame: baseline
Identification of the key histopathological features in liver biopsy that aid in differentiation intra-hepatic and extra-hepatic causes of persistent neonatal jaundice (PNJ).
1 secondary outcome
Evaluation of significance of liver biopsy as a diagnostic tool
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 16700389Mansour E, Eissa AN, Nofal LM, Kharboush I, Reda AA. Morbidity and mortality of low-birth-weight infants in Egypt. East Mediterr Health J. 2005 Jul;11(4):723-31.
- Background: PubMed 27429428Fawaz R, Baumann U, Ekong U, Fischler B, Hadzic N, Mack CL, McLin VA, Molleston JP, Neimark E, Ng VL, Karpen SJ. Guideline for the Evaluation of Cholestatic Jaundice in Infants: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):154-168. doi: 10.1097/MPG.0000000000001334.
- Background: PubMed 38008855Ali KM, Zalata KR, Barakat T, Elzeiny SM. Pathologic approach to Neonatal cholestasis with a simple scoring system for biliary atresia. Virchows Arch. 2024 Jan;484(1):93-102. doi: 10.1007/s00428-023-03704-5. Epub 2023 Nov 27.
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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.
Moemen M Hafez, M.D. study director
Faculty of Medicine, Assiut University, Assiut, Egypt
Abeer M Refaiy, M.D. study director
Faculty of Medicine, Assiut University, Assiut, Egypt
Questions about this trial
What is this clinical trial studying?
A study testing Liver biopsy in people with Neonatal Cholestasis and Neonatal Jaundice, run by Assiut University.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan H Fouad, MBBCh (+201229788587, nourhannasr97@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the key histopathological features in liver biopsy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628726, which also lists 3 linked publications.
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 8 Oct 2024.