Parenteral Nutrition Associated CholestasisPhase 3NCT01555957
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis
A Phase 3 study testing intravenous lipid in people with Parenteral Nutrition Associated Cholestasis, run by University of Rochester at 1 site in United States.
Trial summary
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Parenteral Nutrition Associated Cholestasis
- What is being tested?
- intravenous lipid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 31 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study
Who cannot join
- If does not need TPN by 72 hours;
- Direct hyperbilirubinemia within the first 72 hours after birth;
- TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
- Biliary tract disorders leading to direct hyperbilirubinemia;
- Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
- Being tested
- intravenous lipid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous lipidDrug
intravenous given daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| low dose intravenous lipids | Experimental | Not described Receives: Drug: intravenous lipid |
| high dose of intravenous lipids | Placebo comparator | Not described Receives: Drug: intravenous lipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Parenteral Nutrition Associated Cholestasis
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
Measured: 7 weeks
Secondary outcomes (1)
Mean Rate of Change in Direct Bilirubin
Amount of direct (conjugated) bilirubin was measured from sera samples.
Measured: baseline, weeks 1, 2, 3, 4, 5 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completion30 Oct 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parenteral Nutrition Associated CholestasisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjiv Amin, MD, Principal investigator, University of RochesterKunal Gupta, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555957
- Sponsor's protocol ID
- URochester
- Status last verified
- Dec 2020
- First submitted
- 14 Mar 2012
- Last updated
- 3 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lipid Intake on Direct Hyperbilirubinemia in Late Preterm and Term Infants With Gastrointestinal Surgical Problems.
- ClinicalTrials.gov ID
- NCT01555957
- Acronym / sponsor ID
- URochester
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose intravenous lipids | Experimental | Drug: intravenous lipid |
| high dose of intravenous lipids | Placebo comparator | Drug: intravenous lipid |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study
Key exclusion criteria (5 listed)
- If does not need TPN by 72 hours;
- Direct hyperbilirubinemia within the first 72 hours after birth;
- TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
- Biliary tract disorders leading to direct hyperbilirubinemia;
- Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
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 |
|---|---|---|
| intravenous lipidintravenous given daily for 6 weeks | Drug | high dose of intravenous lipids, low dose intravenous lipids |
Primary outcome
Number of Participants With Parenteral Nutrition Associated Cholestasis
Time frame: 7 weeks
Defined as direct bilirubin ≥ 2mg/dl developing within one week of the completion of 6 week randomization period
1 secondary outcome
Mean Rate of Change in Direct Bilirubin
Time frame: baseline, weeks 1, 2, 3, 4, 5 and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Parenteral Nutrition Associated Cholestasis
RecruitingPhase 4
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
Malnutrition, Child, Malnutrition
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.
Sanjiv Amin, MD principal investigator
University of Rochester
Kunal Gupta, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravenous lipid in people with Parenteral Nutrition Associated Cholestasis, run by University of Rochester at 1 site in United States.
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 5 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 3 Dec 2020. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Parenteral Nutrition Associated Cholestasis (time frame: 7 weeks). 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 3 Dec 2020; AzTrials last refreshed its copy on 7 Nov 2026.