the Necrotizing EnterocolitisECUNNCT02872350
Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
A study testing Abdominal ultrasound in people with the Necrotizing Enterocolitis and Preterm Infants, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants. The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Read more about this study
- Who is it for?
- Ages Up to 33 weeks
- Conditions the study is for
- the Necrotizing Enterocolitis, Preterm Infants
- What is being tested?
- Abdominal ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Apr 2019
- 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 Up to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth Term strictly less than 33SA
- Gestational age some (assessed on early ultrasound dating)
- Congenital malformation of Absence
- Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
- Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
- Maximum interval between imaging tests 2 hours
- No parental opposition to the participation of children in the study
Who cannot join
- Term higher or equal to 33 weeks
- Congenital malformation
- Parental Opposition (or legal representatives) to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Aurelie GARBI, PH, 0491968300, aurelie.garbi@ap-hm.fr
Urielle DESALBRES, Director, 0491382747, drci@ap-hm.fr
About this study
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.
The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.
Read more
Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.
The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.
- Conditions
- the Necrotizing Enterocolitis, Preterm Infants
- Being tested
- Abdominal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasoundDevice
Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.
| Study group | Role | What they receive |
|---|---|---|
| Premature with necrotizing enterocolitis | Experimental | Not described Receives: Device: Abdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comment prognostic evaluation by abdominal ultrasound
Assessment in clinical outcome prognosis by abdominal ultrasound
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872350
- Sponsor's protocol ID
- 2015-34
- Other IDs
- 2015-A01628-41
- Acronym
- ECUN
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
- ClinicalTrials.gov ID
- NCT02872350
- Acronym / sponsor ID
- ECUN / 2015-34
- Conditions
- the Necrotizing Enterocolitis, Preterm Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 19 Aug 2016 (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.
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.
The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.
Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.
The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Premature with necrotizing enterocolitis | Experimental | Device: Abdominal ultrasound |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Birth Term strictly less than 33SA
- Gestational age some (assessed on early ultrasound dating)
- Congenital malformation of Absence
- Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
- Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
Key exclusion criteria (3 listed)
- Term higher or equal to 33 weeks
- Congenital malformation
- Parental Opposition (or legal representatives) to participate in the study
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 |
|---|---|---|
| Abdominal ultrasoundTechniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA. | Device | Premature with necrotizing enterocolitis |
Primary outcome
Comment prognostic evaluation by abdominal ultrasound
Time frame: 36 months
Assessment in clinical outcome prognosis by abdominal ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal ultrasound in people with the Necrotizing Enterocolitis and Preterm Infants, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 19 Aug 2016. 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 France. 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?
Contact Aurelie GARBI, PH (0491968300, aurelie.garbi@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comment prognostic evaluation by abdominal ultrasound (time frame: 36 months). 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 19 Aug 2016.