Necrotizing EnterocolitisNCT00252681
Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants
A study testing laparotomy and primary peritoneal drainage in people with Necrotizing Enterocolitis, run by Yale University at 1 site in United States.
Trial summary
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies. Read more about this study
- Who is it for?
- Ages 0 years to 3 months
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- laparotomy and primary peritoneal drainage
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1999to Jun 2005
- 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 0 years to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight less than 1500 grams
- Gestational age 24 -33 weeks
- Diagnosed with necrotizing enterocolitis based on Bell stage II or greater
- Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.
Who cannot join
- Bilateral Grade IV intraventricular hemorrhage
- Previous abdominal surgery
- Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine Section of Pediatric Surgery
New Haven, Connecticut, 06520
About this study
Official title: Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial
The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
Read the detailed description
This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.
Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- laparotomy, primary peritoneal drainage
- Keywords
- randomized, controlled, trial, necrotizing, enterocolitis, premature, infants, laparotomy, peritoneal, drainage
- Medical subject headings
- Enterocolitis, Necrotizing, Enterocolitis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparotomyProcedure or surgery
primary peritoneal drainageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.
Secondary outcomes (1)
The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startJul 1999
- Study completionJun 2005
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.
- More trials run by Yale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
- Investigators
- R. Lawrence Moss, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252681
- Sponsor's protocol ID
- R01HD038462
- Other IDs
- Gen Clin Res Ctr #M01-RR00125
- Status last verified
- Nov 2005
- First submitted
- 9 Nov 2005
- Last updated
- 21 Jul 2006
- Results posted
- No
Publications
Moss RL, Dimmitt RA, Barnhart DC, Sylvester KG, Brown RL, Powell DM, Islam S, Langer JC, Sato TT, Brandt ML, Lee H, Blakely ML, Lazar EL, Hirschl RB, Kenney BD, Hackam DJ, Zelterman D, Silverman BL. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med. 2006 May 25;354(21):2225-34. doi: 10.1056/NEJMoa054605.
PubMed 16723614
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial
- ClinicalTrials.gov ID
- NCT00252681
- Acronym / sponsor ID
- R01HD038462
- Conditions
- Necrotizing Enterocolitis
- Keywords
- randomized, controlled, trial, necrotizing, enterocolitis, premature, infants, laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)
- Study start
- Jul 1999
- Study completion
- Jun 2005
- First posted
- 11 Nov 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 primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.
Detailed description
This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.
Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (<1000 gms and 1000 - 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth weight less than 1500 grams
- Gestational age 24 -33 weeks
- Diagnosed with necrotizing enterocolitis based on Bell stage II or greater
- Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.
Key exclusion criteria (3 listed)
- Bilateral Grade IV intraventricular hemorrhage
- Previous abdominal surgery
- Evidence of gastrointestinal anomaly (i.e. atresia, malrotation 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 |
|---|---|---|
| laparotomy | Procedure or surgery | – |
| primary peritoneal drainage | Procedure or surgery | – |
Primary outcome
The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.
1 secondary outcome
The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2006.
- Results publication: PubMed 16723614Moss RL, Dimmitt RA, Barnhart DC, Sylvester KG, Brown RL, Powell DM, Islam S, Langer JC, Sato TT, Brandt ML, Lee H, Blakely ML, Lazar EL, Hirschl RB, Kenney BD, Hackam DJ, Zelterman D, Silverman BL. Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med. 2006 May 25;354(21):2225-34. doi: 10.1056/NEJMoa054605.
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
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Early Predictors of Necrotizing Enterocolitis in Neonates
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Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
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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
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparotomy and primary peritoneal drainage in people with Necrotizing Enterocolitis, run by Yale University 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 4 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: finished, as of the sponsor's last update on 21 Jul 2006. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.. 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 NCT00252681, 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 21 Jul 2006.