Necrotizing EnterocolitisNECNCT00588718
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
An observational study of Necrotizing Enterocolitis, run by R. Lawrence Moss at 1 site in United States.
Trial summary
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Read more about this study
- Who is it for?
- Ages 72 hours to 28 weeks
- Conditions the study is for
- Necrotizing Enterocolitis
- How many people
- 740 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2019
- 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 72 hours to 28 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria
Inclusion Criteria - NEC/Sepsis Cohort GA < 29 weeks Current age equal or <12 weeks Suspicion of NEC or Sepsis
Exclusion - NEC/Sepsis Cohort Current or prior diagnosis of NEC Early onset infection (equal or <72 hours of life) Previous diagnosis of sepsis within 7 days Previous abdominal surgery Significant congenital anomaly
Inclusion Criteria - SIP Cohort Infants born at <29 weeks gestation Equal to or <12 weeks of age at the time of eligibility assessment a decision to perform surgery (or drain) for suspected NEC or SIP
Exclusion - SIP Cohort Congenital infection (Equal to <72 hours of life) Prior episode of NEC or SIP Prior laparotomy or drain for SIP or NEC
Trial locations and contacts
1 site in 1 country.
United States1 site
R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia
Columbus, Ohio, 43205
About this study
Official title: A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.
In this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing enterocolitis, Progressive necrotizing enterocolitis, Proteomics in blood, Genomics in blood, Multi-center
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Infants who meet the entry criteria | |
| Controls | Banked blood samples from newborns who do not meet inclusion criteria for this study will be held at Stanford University Core Laboratory and will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
Study has been amended/extended. Test the NEC diagnostic panel for its ability to distinguish NEC from SIP. Develop validated biomarkers on biosensors in preparation for prospective validation studies.
Independent prospective validation of biosensor based biomarker panels.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 740 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R. Lawrence Moss
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt, Stanford University, Baylor College of Medicine, Johns Hopkins University, University of Pennsylvania, Yale University
- Responsible party
- Sponsor-investigator, R. Lawrence Moss, Nationwide Children's Hospital
- Investigators
- R. Lawrence Moss, MD, Principal investigator, Nationwide Children's Hospital, The Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588718
- Sponsor's protocol ID
- 26128
- Acronym
- NEC
- Status last verified
- Mar 2018
- First submitted
- 3 Jan 2008
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Moss RL, Kalish LA, Duggan C, Johnston P, Brandt ML, Dunn JC, Ehrenkranz RA, Jaksic T, Nobuhara K, Simpson BJ, McCarthy MC, Sylvester KG. Clinical parameters do not adequately predict outcome in necrotizing enterocolitis: a multi-institutional study. J Perinatol. 2008 Oct;28(10):665-74. doi: 10.1038/jp.2008.119. Epub 2008 Sep 11.
PubMed 18784730
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis
- ClinicalTrials.gov ID
- NCT00588718
- Acronym / sponsor ID
- NEC / 26128
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing enterocolitis, Progressive necrotizing enterocolitis, Proteomics in blood, Genomics in blood, Multi-center
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 740 participants (estimated)
- Lead sponsor
- R. Lawrence MossUniversity, hospital or other
- Collaborators
- Mallinckrodt, Stanford University, Baylor College of Medicine, Johns Hopkins University, University of Pennsylvania, Yale University
- Study start
- Apr 2007 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Jan 2008 (estimated)
- 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.
Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.
In this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Infants who meet the entry criteria |
| Controls | – | –Banked blood samples from newborns who do not meet inclusion criteria for this study will be held at Stanford University Core Laboratory and will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls. |
Who may qualify
- Ages
- 72 hours to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.
Time frame: 4 years
Study has been amended/extended. Test the NEC diagnostic panel for its ability to distinguish NEC from SIP. Develop validated biomarkers on biosensors in preparation for prospective validation studies. Independent prospective validation of biosensor based biomarker panels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Results publication: PubMed 18784730Moss RL, Kalish LA, Duggan C, Johnston P, Brandt ML, Dunn JC, Ehrenkranz RA, Jaksic T, Nobuhara K, Simpson BJ, McCarthy MC, Sylvester KG. Clinical parameters do not adequately predict outcome in necrotizing enterocolitis: a multi-institutional study. J Perinatol. 2008 Oct;28(10):665-74. doi: 10.1038/jp.2008.119. Epub 2008 Sep 11.
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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.
R. Lawrence Moss, MD principal investigator
Nationwide Children's Hospital, The Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by R. Lawrence Moss 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?
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 9 Mar 2018. 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. 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?
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?
To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts. (time frame: 4 years). 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 NCT00588718, which also lists 1 linked publication.
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 Mar 2018.