Neonatal CholestasisTPNNCT05163145
Risk Factor for Cholestasis in Neonates Receiving TPN(Total Parenteral Nutrition)
An observational study of Neonatal Cholestasis and Total Parenteral Nutrition Effect, run by Mayyada Elsayed Mohamed Hussien.
Trial summary
The aim of this study is to evaluate the risk factors of PNAC in neonates Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Cholestasis, Total Parenteral Nutrition Effect
- What is being tested?
- TPN
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 2 Mar 2023
- Phase
- Observational
- 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 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: All neonates who received PN for≥14days and admitted to our children's hospital's NICU
Who may be able to join
- Neonates who received PN for ≥14 days
- Exclusion Criteria::Neonates with major congenital anomaly, cholestasis at birth,diseases associated with cholestasis (i.e.,inborn errors of metabolism,viral hepatitis,cystic fibrosis and any primary cholestatic liver diseases)that were diagnosed while hospitalized.the possibility of surgical causes of conjugated hyperbilirubinemia(such as biliary atresia,choledochalcyst on abdominal ultrasonography,and hepatobiliary scintigraphy
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Risk Factor for Cholestasis in Neonates receivingTPN At Assiut University Children Hospital
The aim of this study is to evaluate the risk factors of PNAC in neonates
Read the detailed description
Neonates with prematurity,gastrointestinal dysfunction and very low birth weights are often intolerant to oral feeding.In such infants,the provision of nutrients via parenteral nutrition (PN)becomes necessary for short term survival,as well as long-term health. Wilmore and Dudrick first reported use of parenteral nutrition(PN) for an infant more than 40years ago Soon there after physicians recognized that PN was associated with significant liver changes.In the first reported case of parenteral nutrition-associated conjugated hyperbilirubinemia (PNAC) in a premature infant hepatomegaly was noted on the18thday of fat-free PN and worsened until death on the71st day of life The hyperbilirubinemia manifest in PNAC is thought to occur from impaired hepatic bileflow, an adynamic gallbladder,and an upsurge in release of conjugated bilirubin as an infant matures.Atbirth,preterm neonates havereduced activity of the uridine diphosphate glucuronosyl transferase1A1 liver enzyme(UDPGT)that catalyzes conjugation of bilirubin As the infant develops,UDPGT becomes more functional, increasing hepatocyte efficiency for conjugation.Thus,in combination with cholestasis,and neonatal intestinal absorption of unconjugated bilirubin,more conjugated bilirubin is made available to pass from the liver into circulation. Parenteral nutrition associated cholestasis (PNAC) is the most common form of liver damage in neonates while receiving parenteral nutrition(PN).Its prevalence was reported between10%and 60%in NICU Cholestasisis acommonly described complication of PN. Its etiology is not fully understood and is thought to be multifactorial Proposed mechanisms included altered bile salt metabolisms secondary to prematurity and toxic effect of PN components on the liver the presence or absence of specific components in parenteral nutrition solutions most certainly contributing to the disease mechanism,and gastrointestinal systems .Aggravating factors such as sepsis and duration of bowel rest have also been described
- Being tested
- TPN
- Keywords
- TPN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPNOther
early detection of comlications of prolonged TPN on neonatal liver
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of TPN on neonatal liver
TPN associated cholestasis in neonates
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal CholestasisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayyada Elsayed Mohamed Hussien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mayyada Elsayed Mohamed Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163145
- Sponsor's protocol ID
- neonates receiveTPN
- Acronym
- TPN
- Status last verified
- May 2022
- First submitted
- 6 Dec 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factor for Cholestasis in Neonates receivingTPN At Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT05163145
- Acronym / sponsor ID
- TPN / neonates receiveTPN
- Keywords
- TPN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayyada Elsayed Mohamed HussienUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 20 Dec 2021 (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.
The aim of this study is to evaluate the risk factors of PNAC in neonates
Detailed description
Neonates with prematurity,gastrointestinal dysfunction and very low birth weights are often intolerant to oral feeding.In such infants,the provision of nutrients via parenteral nutrition (PN)becomes necessary for short term survival,as well as long-term health. Wilmore and Dudrick first reported use of parenteral nutrition(PN) for an infant more than 40years ago Soon there after physicians recognized that PN was associated with significant liver changes.In the first reported case of parenteral nutrition-associated conjugated hyperbilirubinemia (PNAC) in a premature infant hepatomegaly was noted on the18thday of fat-free PN and worsened until death on the71st day of life The hyperbilirubinemia manifest in PNAC is thought to occur from impaired hepatic bileflow, an adynamic gallbladder,and an upsurge in release of conjugated bilirubin as an infant matures.Atbirth,preterm neonates havereduced activity of the uridine diphosphate glucuronosyl transferase1A1 liver enzyme(UDPGT)that catalyzes conjugation of bilirubin As the infant develops,UDPGT becomes more functional, increasing hepatocyte efficiency for conjugation.Thus,in combination with cholestasis,and neonatal intestinal absorption of unconjugated bilirubin,more conjugated bilirubin is made available to pass from the liver into circulation. Parenteral nutrition associated cholestasis (PNAC) is the most common form of liver damage in neonates while receiving parenteral nutrition(PN).Its prevalence was reported between10%and 60%in NICU Cholestasisis acommonly described complication of PN. Its etiology is not fully understood and is thought to be multifactorial Proposed mechanisms included altered bile salt metabolisms secondary to prematurity and toxic effect of PN components on the liver the presence or absence of specific components in parenteral nutrition solutions most certainly contributing to the disease mechanism,and gastrointestinal systems .Aggravating factors such as sepsis and duration of bowel rest have also been described
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All neonates who received PN for≥14days and admitted to our children's hospital's NICU
Key inclusion criteria (3 listed)
- Neonates who received PN for ≥14 days
- Exclusion Criteria::Neonates with major congenital anomaly, cholestasis at birth,diseases associated with cholestasis (i.e.,inborn errors of metabolism,viral hepatitis,cystic fibrosis and any primary cholestatic liver diseases)that were diagnosed while hospitalized.the possibility of surgical causes of conjugated hyperbilirubinemia(such as biliary atresia,choledochalcyst on abdominal ultrasonography,and hepatobiliary scintigraphy
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TPNearly detection of comlications of prolonged TPN on neonatal liver | Other | – |
Primary outcome
effect of TPN on neonatal liver
Time frame: baseline
TPN associated cholestasis in neonates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Cholestasis and Total Parenteral Nutrition Effect, run by Mayyada Elsayed Mohamed Hussien.
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 3 inclusion and 0 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 20 May 2022. 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 Mayyada ElsayedMohamed, resident (01002686656, soadalsayed2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of TPN on neonatal liver (time frame: baseline). 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 20 May 2022.