Necrotizing EnterocolitisNCT03257553
Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis
A study testing fecal calprotectin , doppler and ultrasound in people with Necrotizing Enterocolitis, run by Assiut University.
Trial summary
Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram) Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- fecal calprotectin , doppler and ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year .
- Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy).
- Exclusion Criteria:surgical problems other than NEC ,NEC beyond neonatal period.
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates
Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)
Read the detailed description
Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live births among all neonates and 33 infants per 1000 live births among very low-birth-weight (below 1500 gram).
Necrotising enterocolitis presents with both gastrointestinal and systemic signs. Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools. Non specific signs as lethargy, apnea, respiratory distress.
Although clinical and characteristic radiological findings remain the most important tools so far. Unfortunately, these signs are usually detectable in an advanced stage of disease.
- Haematological studies as severe or persistent thrombocytopenia, neutropenia, coagulopathy, or acidosis might indicate severe disease.
- Serial C-reactive protein : that persistently high C-reactive protein indicated developing complications, such as stricture or abscess.
Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not allow proper discrimination from sepsis Therefore, the search for disease-specific, early and noninvasive diagnostic biomarkers remains warranted.
Calprotectin, a peptide secreted by neutrophils and macrophages and is a useful laboratory biomarker for diagnosing necrotizing enterocolitis . Its non-specific biomarkers of inflammation, but the nature of the specimen, e.g. stool, renders these mediators more indicative of the site of tissue injury. And its levels may be a marker for early diagnosis and resolution of gastrointestinal illness , but its utility for early diagnosis and assessment of resolution of necrotizing enterocolitis needs to be studied in a larger studies.
Plain X ray: Definite signs include pneumatosis intestinalis (intramural air) and portal venous gas .
Ultrasound : More sensitive and accurate imaging studies and could become helpful adjuncts to abdominal films in the diagnosis of necrotizing enterocolitis .
The major advantage of sonography over plain abdominal radiography is its superiority in depicting small amount of gas. Ultrasound with Doppler might be more sensitive than abdominal films for detecting necrotic bowel requiring surgical intervention.
When necrotizing enterocolitis is suspected, infants are given bowel rest , bowel decompression, and broad-spectrum antibiotics (after cultures are obtained). Anaerobic coverage should be considered. Adjunctive therapy includes cardiovascular, pulmonary, and haematological support as clinically indicated.
The two main options available for the surgical management of necrotizing enterocolitis are exploratory laparotomy and primary peritoneal drainage .
- Conditions
- Necrotizing Enterocolitis
- Being tested
- fecal calprotectin , doppler and ultrasound
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal calprotectin , doppler and ultrasoundDiagnostic test
faecal sample for measurement of calprotectin level ultrasound and doppler
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | do fecal calprotectin, doppler and ultrasound for each patient Receives: Diagnostic Test: fecal calprotectin , doppler and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of necrotizing enterocolitis
diagnosis of necrotizing enterocolitis by ultrasound, doppler and calprotectin and compare to see more sensitive and specific method of them in comparison with plain erect
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study startApr 2018 (estimated)
- Primary completionOct 2018 (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 Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azhar Arabi mohammed, Assiut University
- Investigators
- Azhar Arabi, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257553
- Sponsor's protocol ID
- UDFNEC
- Status last verified
- Jan 2018
- First submitted
- 14 Aug 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates
- ClinicalTrials.gov ID
- NCT03257553
- Acronym / sponsor ID
- UDFNEC
- Conditions
- Necrotizing Enterocolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 22 Aug 2017 (actual)
- 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 continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)
Detailed description
Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live births among all neonates and 33 infants per 1000 live births among very low-birth-weight (below 1500 gram).
Necrotising enterocolitis presents with both gastrointestinal and systemic signs. Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools. Non specific signs as lethargy, apnea, respiratory distress.
Although clinical and characteristic radiological findings remain the most important tools so far. Unfortunately, these signs are usually detectable in an advanced stage of disease.
- Haematological studies as severe or persistent thrombocytopenia, neutropenia, coagulopathy, or acidosis might indicate severe disease.
- Serial C-reactive protein : that persistently high C-reactive protein indicated developing complications, such as stricture or abscess.
Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not allow proper discrimination from sepsis Therefore, the search for disease-specific, early and noninvasive diagnostic biomarkers remains warranted.
Calprotectin, a peptide secreted by neutrophils and macrophages and is a useful laboratory biomarker for diagnosing necrotizing enterocolitis . Its non-specific biomarkers of inflammation, but the nature of the specimen, e.g. stool, renders these mediators more indicative of the site of tissue injury. And its levels may be a marker for early diagnosis and resolution of gastrointestinal illness , but its utility for early diagnosis and assessment of resolution of necrotizing enterocolitis needs to be studied in a larger studies.
Plain X ray: Definite signs include pneumatosis intestinalis (intramural air) and portal venous gas .
Ultrasound : More sensitive and accurate imaging studies and could become helpful adjuncts to abdominal films in the diagnosis of necrotizing enterocolitis .
The major advantage of sonography over plain abdominal radiography is its superiority in depicting small amount of gas. Ultrasound with Doppler might be more sensitive than abdominal films for detecting necrotic bowel requiring surgical intervention.
When necrotizing enterocolitis is suspected, infants are given bowel rest , bowel decompression, and broad-spectrum antibiotics (after cultures are obtained). Anaerobic coverage should be considered. Adjunctive therapy includes cardiovascular, pulmonary, and haematological support as clinically indicated.
The two main options available for the surgical management of necrotizing enterocolitis are exploratory laparotomy and primary peritoneal drainage .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Diagnostic Test: fecal calprotectin , doppler and ultrasounddo fecal calprotectin, doppler and ultrasound for each patient |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year .
- Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy).
- Exclusion Criteria:surgical problems other than NEC ,NEC beyond neonatal period.
- -
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fecal calprotectin , doppler and ultrasoundfaecal sample for measurement of calprotectin level ultrasound and doppler | Diagnostic test | intervention arm |
Primary outcome
diagnosis of necrotizing enterocolitis
Time frame: one year
diagnosis of necrotizing enterocolitis by ultrasound, doppler and calprotectin and compare to see more sensitive and specific method of them in comparison with plain erect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Related trials for Necrotizing Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Azhar Arabi, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing fecal calprotectin , doppler and ultrasound in people with Necrotizing Enterocolitis, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Abdel Latif Abdel Moez, MD (01005208016, abdellatefabdelmoez@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis of necrotizing enterocolitis (time frame: one year). 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 23 Jan 2018.