Necrotizing EnterocolitisNCT00059449
Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
An observational study of Necrotizing Enterocolitis and Premature Birth, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 3 sites in United States.
Trial summary
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Necrotizing Enterocolitis, Premature Birth
- How many people
- 372 participants
- Where
- 3 sitesUnited States
- Study dates
- Start not givento 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational Age greater than 23 weeks at birth
- Birth weight greater than 500 grams
- Age less than 72 hours of life
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospital
Cincinnati, Ohio, 45229
About this study
Necrotizing enterocolitis (NEC) is a serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. The most important factor in its development is a premature intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the development and maintenance of the gastrointestinal tract. This study will look for a relationship between EGF levels in premature babies and the development of NEC.
- Conditions
- Necrotizing Enterocolitis, Premature Birth
- Keywords
- Enterocolitis
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth, Enterocolitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2003 (estimated)
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prospective
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059449
- Sponsor's protocol ID
- EGFDNE (completed)
- Status last verified
- Jan 2010
- First submitted
- 25 Apr 2003
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Epidermal Growth Factor (EGF) in Development of Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT00059449
- Acronym / sponsor ID
- EGFDNE (completed)
- Conditions
- Necrotizing Enterocolitis, Premature Birth
- Keywords
- Enterocolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- First posted
- 29 Apr 2003 (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 serious gastrointestinal disorder that primarily affects preterm infants. About 10% of babies less than 32 weeks gestation at birth will develop it. Overall, 30% of babies who develop NEC will die from it, with many others developing long term gastrointestinal problems. The most important factor in its development is a premature intestinal tract. Epidermal growth factor (EGF) is an important growth factor in the development and maintenance of the gastrointestinal tract. This study will look for a relationship between EGF levels in premature babies and the development of NEC.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational Age greater than 23 weeks at birth
- Birth weight greater than 500 grams
- Age less than 72 hours of life
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.
Primary outcome
Not reported in the source record.
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 13 Jan 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 and Premature Birth, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 3 sites 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 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: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 13 Jan 2010.