Necrotizing EnterocolitisNCT00120159
Necrotizing Enterocolitis (NEC) Surgical Database
An observational study of Necrotizing Enterocolitis, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Necrotizing Enterocolitis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to not given
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must meet at least one criterion from each of the following three categories:
- Historical Factors:
- Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile
- Apneic/bradycardic episodes
- Oxygen desaturation episode not otherwise explained
- Guaiac positive or grossly bloody stools
Show all 21Show fewer
- Physical Examination Findings:
- Abdominal distention recorded by practitioner
- Capillary refill time greater than 2 seconds
- Abdominal wall discoloration
- Abdominal tenderness
- Radiographic Findings:
- Pneumatosis intestinalis
- Portal venous gas
- Ileus
- Dilated bowel
- Pneumoperitoneum
- Air/fluid levels
- Thickened bowel walls
- Ascites or peritoneal fluid
- Free intraperitoneal air
Who cannot join
- Patients will be excluded for any of the following:
- Major gastrointestinal anomaly
- Prior abdominal operation
- Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital, Boston
Boston, Massachusetts, 02115
About this study
Official title: GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol
The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing Enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation, Yale University
- Investigators
- Tom Jaskic, MPH, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120159
- Sponsor's protocol ID
- X03-12-080
- Status last verified
- Jan 2006
- First submitted
- 30 Jun 2005
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol
- ClinicalTrials.gov ID
- NCT00120159
- Acronym / sponsor ID
- X03-12-080
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Necrotizing Enterocolitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation, Yale University
- Study start
- Dec 2003
- First posted
- 15 Jul 2005 (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.
The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile
- Apneic/bradycardic episodes
- Oxygen desaturation episode not otherwise explained
- Guaiac positive or grossly bloody stools
- Abdominal distention recorded by practitioner
Key exclusion criteria (4 listed)
- Major gastrointestinal anomaly
- Prior abdominal operation
- Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2008.
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Necrotizing Enterocolitis
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.
Tom Jaskic, MPH, PhD principal investigator
Boston Children's Hospital
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 Boston Children's Hospital 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 21 inclusion and 4 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 15 Jan 2008. 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.
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 15 Jan 2008.