Enterocolitis, NecrotizingNCT03963011
NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies
A study testing Bowel Ultrasound in people with Enterocolitis, Necrotizing and Premature Infant, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. Read more about this study
- Who is it for?
- Ages Up to 28 weeks
- Conditions the study is for
- Enterocolitis, Necrotizing, Premature Infant
- What is being tested?
- Bowel Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2018to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Neonates born prior to or at 28 weeks gestation admitted to NICU at CMH
Who cannot join
- Infants with chromosomal or multiple congenital anomalies
- Unable to ultrasound the bowel (e.g. gut in silo, omphalocele, gastroschisis)
- Infants who are greater than 36 corrected weeks upon admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Premature Neonates
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. This program of research is anticipated to have a significant positive impact in the timely and accurate diagnosis of NEC in preterm infants.
Read the detailed description
Necrotizing enterocolitis (NEC) is the most common bowel disease in premature and low birth weight neonates. NEC is defined by the loss of mucosal integrity of the bowel wall enabling bacteria and other toxins to permeate into the bowel causing ischemia and necrosis which can lead to bowel perforation and sepsis. NEC can result in substantial morbidity and mortality and prolonged hospital stay.
In the past, abdominal radiography has been scored on a standard scale that correlated with outcomes. Duke University Medical Center developed a standardized ten-point radiographic scale, the Duke Abdominal Assessment Scale (DAAS) (Appendix B) and was proven to be directly proportional to the severity of NEC on patients that underwent surgery. Abdominal radiographs are assessed for gas pattern, bowel distention, location and features, pneumatosis (gas in bowel wall), portal venous gas, and pneumoperitoneum (free air in peritoneal cavity) to indicate the level of suspicion of NEC. The use of abdominal radiographs is the most common assessment for suspected NEC in infants, however, there have been recent studies done on the utility of bowel ultrasound to aid in early diagnosis of NEC due to the ability to evaluate peristalsis, echogenicity and thickness of bowel wall, pneumatosis and the capability of doing color Doppler to evaluate blood perfusion. A University of Toronto study used ultrasound to assess bowel perfusion with color Doppler in neonates and found a correlation between absence of bowel wall perfusion and the increased severity of NEC on surgical pathology. Although there are similar signs found between abdominal radiography and bowel ultrasound, some of the more severe features such as, pneumoperitoneum, were found to be more sensitive on bowel ultrasound, thus potentially leading to more definitive treatment. Currently, there is no good study evaluating whether the use of bowel ultrasound affects clinical outcomes in VLBW patients over the use of abdominal radiography alone.
The use bowel ultrasound has yet to be adopted in the setting of suspicion for NEC at our institution. This is primarily due to the lack of expertise of the ultrasound technologists, radiologists and clinicians. With literature dating back to 2005 supporting the use of bowel ultrasound in diagnosis of severity of NEC, we would like to see if a regimen involving combined ultrasound and radiograph screening for NEC would make a difference in clinical outcomes (morbidity, mortality, and length of stay (LOS)) compared with radiograph screening alone.
Calprotectin is a protein found in the stool that, at elevated levels, indicates gastrointestinal inflammation. The addition of fecal biomarkers to the diagnostic work up for NEC also has promising impact. It has been suggested that fecal calprotectin levels obtained at the time of suspicion of NEC may be a useful noninvasive indicator to determine the severity of inflammation in the intestine and whether it is related to NEC or other forms of inflammation. Correlation of the fecal biomarkers with findings on BUS may be helpful to more definitively diagnose NEC.
- Conditions
- Enterocolitis, Necrotizing, Premature Infant
- Being tested
- Bowel Ultrasound
- Keywords
- NEC, Necrotizing Enterocolitis, Premature Infant, Calprotectin
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel UltrasoundDiagnostic test
Ultrasound imaging of the bowel
| Study group | Role | What they receive |
|---|---|---|
| Arm A: AXR Only | No intervention | Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care |
| Arm B: AXR + Bowel US | Active comparator | Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention Receives: Diagnostic Test: Bowel Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Requiring Medical Management
Evaluate the difference between medical and surgical management between study arms.
Medical management is defined as subjects whom did not undergo surgery for their NEC diagnosis.
Surgical management is defined as subjects that had a surgical intervention for the NEC diagnosis.
Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Measured: First 12 months
Number of Days Between NEC Diagnosis and Surgical Intervention
The number of days between NEC diagnosis and surgical intervention for those that need it. Days were continuously counted until subject was discharged from the hospital.
Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Measured: 12 months
Number of NPO Days
Number of nothing by mouth (NPO) days between subject diagnosis of NEC to when subject was placed back on continuous feeds.
Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start20 Dec 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Enterocolitis, NecrotizingStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants randomized to the AXR only arm will obtain an AXR as per standard of care. Repeat AXR, if any, will be left to the discretion of the treating neonatologist. In this arm, no BUS study will be performed unless the attending neonatologist decides it is clinically indicated. This situation is expected to be exceedingly rare, as BUS is not part of the standard of care for NEC evaluation. Infants randomized to the AXR and BUS arm will also get an AXR, with repeat AXR left to the discretion of the treating neonatologist. In addition to this standard of care, infants randomized to this arm will receive a BUS as the intervention. This BUS will be ordered at the same time as the initial AXR and will be performed within six hours of the order being placed.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Opfer, DO, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963011
- Sponsor's protocol ID
- 17030157
- Status last verified
- Dec 2021
- First submitted
- 19 Dec 2018
- Last updated
- 10 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Epelman M, Daneman A, Navarro OM, Morag I, Moore AM, Kim JH, Faingold R, Taylor G, Gerstle JT. Necrotizing enterocolitis: review of state-of-the-art imaging findings with pathologic correlation. Radiographics. 2007 Mar-Apr;27(2):285-305. doi: 10.1148/rg.272055098.
PubMed 17374854Staryszak J, Stopa J, Kucharska-Miasik I, Osuchowska M, Guz W, Blaz W. Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. Pol J Radiol. 2015 Jan 1;80:1-9. doi: 10.12659/PJR.890539. eCollection 2015.
PubMed 25574248Coursey CA, Hollingsworth CL, Gaca AM, Maxfield C, Delong D, Bisset G 3rd. Radiologists' agreement when using a 10-point scale to report abdominal radiographic findings of necrotizing enterocolitis in neonates and infants. AJR Am J Roentgenol. 2008 Jul;191(1):190-7. doi: 10.2214/ajr.07.3558.
PubMed 18562745Coursey CA, Hollingsworth CL, Wriston C, Beam C, Rice H, Bisset G 3rd. Radiographic predictors of disease severity in neonates and infants with necrotizing enterocolitis. AJR Am J Roentgenol. 2009 Nov;193(5):1408-13. doi: 10.2214/AJR.08.2306.
PubMed 19843760Faingold R, Daneman A, Tomlinson G, Babyn PS, Manson DE, Mohanta A, Moore AM, Hellmann J, Smith C, Gerstle T, Kim JH. Necrotizing enterocolitis: assessment of bowel viability with color doppler US. Radiology. 2005 May;235(2):587-94. doi: 10.1148/radiol.2352031718.
PubMed 15858098Kim WY, Kim WS, Kim IO, Kwon TH, Chang W, Lee EK. Sonographic evaluation of neonates with early-stage necrotizing enterocolitis. Pediatr Radiol. 2005 Nov;35(11):1056-61. doi: 10.1007/s00247-005-1533-4. Epub 2005 Aug 3.
PubMed 16078076Nakayuenyongsuk W, Christofferson M, Stevenson DK, Sylvester K, Lee HC, Park KT. Point-of-Care Fecal Calprotectin Monitoring in Preterm Infants at Risk for Necrotizing Enterocolitis. J Pediatr. 2018 May;196:98-103.e1. doi: 10.1016/j.jpeds.2017.12.069. Epub 2018 Mar 6.
PubMed 29519542Cuna A, Chan S, Jones J, Sien M, Robinson A, Rao K, Opfer E. Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis. Eur J Pediatr. 2022 Aug;181(8):3211-3215. doi: 10.1007/s00431-022-04526-4. Epub 2022 Jun 17.
PubMed 35713688
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Control Trial of Necrotizing Enterocolitis Screening Abdominal Radiograph Versus Bowel Ultrasound Plus Abdominal Radiograph in Premature Neonates
- ClinicalTrials.gov ID
- NCT03963011
- Acronym / sponsor ID
- 17030157
- Conditions
- Enterocolitis, Necrotizing, Premature Infant
- Keywords
- NEC, Necrotizing Enterocolitis, Premature Infant, Calprotectin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 10 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. This program of research is anticipated to have a significant positive impact in the timely and accurate diagnosis of NEC in preterm infants.
Detailed description
Necrotizing enterocolitis (NEC) is the most common bowel disease in premature and low birth weight neonates. NEC is defined by the loss of mucosal integrity of the bowel wall enabling bacteria and other toxins to permeate into the bowel causing ischemia and necrosis which can lead to bowel perforation and sepsis. NEC can result in substantial morbidity and mortality and prolonged hospital stay.
In the past, abdominal radiography has been scored on a standard scale that correlated with outcomes. Duke University Medical Center developed a standardized ten-point radiographic scale, the Duke Abdominal Assessment Scale (DAAS) (Appendix B) and was proven to be directly proportional to the severity of NEC on patients that underwent surgery. Abdominal radiographs are assessed for gas pattern, bowel distention, location and features, pneumatosis (gas in bowel wall), portal venous gas, and pneumoperitoneum (free air in peritoneal cavity) to indicate the level of suspicion of NEC. The use of abdominal radiographs is the most common assessment for suspected NEC in infants, however, there have been recent studies done on the utility of bowel ultrasound to aid in early diagnosis of NEC due to the ability to evaluate peristalsis, echogenicity and thickness of bowel wall, pneumatosis and the capability of doing color Doppler to evaluate blood perfusion. A University of Toronto study used ultrasound to assess bowel perfusion with color Doppler in neonates and found a correlation between absence of bowel wall perfusion and the increased severity of NEC on surgical pathology. Although there are similar signs found between abdominal radiography and bowel ultrasound, some of the more severe features such as, pneumoperitoneum, were found to be more sensitive on bowel ultrasound, thus potentially leading to more definitive treatment. Currently, there is no good study evaluating whether the use of bowel ultrasound affects clinical outcomes in VLBW patients over the use of abdominal radiography alone.
The use bowel ultrasound has yet to be adopted in the setting of suspicion for NEC at our institution. This is primarily due to the lack of expertise of the ultrasound technologists, radiologists and clinicians. With literature dating back to 2005 supporting the use of bowel ultrasound in diagnosis of severity of NEC, we would like to see if a regimen involving combined ultrasound and radiograph screening for NEC would make a difference in clinical outcomes (morbidity, mortality, and length of stay (LOS)) compared with radiograph screening alone.
Calprotectin is a protein found in the stool that, at elevated levels, indicates gastrointestinal inflammation. The addition of fecal biomarkers to the diagnostic work up for NEC also has promising impact. It has been suggested that fecal calprotectin levels obtained at the time of suspicion of NEC may be a useful noninvasive indicator to determine the severity of inflammation in the intestine and whether it is related to NEC or other forms of inflammation. Correlation of the fecal biomarkers with findings on BUS may be helpful to more definitively diagnose NEC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants randomized to the AXR only arm will obtain an AXR as per standard of care. Repeat AXR, if any, will be left to the discretion of the treating neonatologist. In this arm, no BUS study will be performed unless the attending neonatologist decides it is clinically indicated. This situation is expected to be exceedingly rare, as BUS is not part of the standard of care for NEC evaluation. Infants randomized to the AXR and BUS arm will also get an AXR, with repeat AXR left to the discretion of the treating neonatologist. In addition to this standard of care, infants randomized to this arm will receive a BUS as the intervention. This BUS will be ordered at the same time as the initial AXR and will be performed within six hours of the order being placed.
| Arm | Type | Receives |
|---|---|---|
| Arm A: AXR Only | No intervention | –Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care |
| Arm B: AXR + Bowel US | Active comparator | Diagnostic Test: Bowel UltrasoundInfants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention |
Who may qualify
- Ages
- Up to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Neonates born prior to or at 28 weeks gestation admitted to NICU at CMH
Key exclusion criteria (3 listed)
- Infants with chromosomal or multiple congenital anomalies
- Unable to ultrasound the bowel (e.g. gut in silo, omphalocele, gastroschisis)
- Infants who are greater than 36 corrected weeks upon admission
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 |
|---|---|---|
| Bowel UltrasoundUltrasound imaging of the bowel | Diagnostic test | Arm B: AXR + Bowel US |
Primary outcome
Number of Participants Requiring Medical Management
Time frame: First 12 months
Evaluate the difference between medical and surgical management between study arms. Medical management is defined as subjects whom did not undergo surgery for their NEC diagnosis. Surgical management is defined as subjects that had a surgical intervention for the NEC diagnosis. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Number of Days Between NEC Diagnosis and Surgical Intervention
Time frame: 12 months
The number of days between NEC diagnosis and surgical intervention for those that need it. Days were continuously counted until subject was discharged from the hospital. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Number of NPO Days
Time frame: 12 months
Number of nothing by mouth (NPO) days between subject diagnosis of NEC to when subject was placed back on continuous feeds. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17374854Epelman M, Daneman A, Navarro OM, Morag I, Moore AM, Kim JH, Faingold R, Taylor G, Gerstle JT. Necrotizing enterocolitis: review of state-of-the-art imaging findings with pathologic correlation. Radiographics. 2007 Mar-Apr;27(2):285-305. doi: 10.1148/rg.272055098.
- Background: PubMed 25574248Staryszak J, Stopa J, Kucharska-Miasik I, Osuchowska M, Guz W, Blaz W. Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. Pol J Radiol. 2015 Jan 1;80:1-9. doi: 10.12659/PJR.890539. eCollection 2015.
- Background: PubMed 18562745Coursey CA, Hollingsworth CL, Gaca AM, Maxfield C, Delong D, Bisset G 3rd. Radiologists' agreement when using a 10-point scale to report abdominal radiographic findings of necrotizing enterocolitis in neonates and infants. AJR Am J Roentgenol. 2008 Jul;191(1):190-7. doi: 10.2214/ajr.07.3558.
- Background: PubMed 19843760Coursey CA, Hollingsworth CL, Wriston C, Beam C, Rice H, Bisset G 3rd. Radiographic predictors of disease severity in neonates and infants with necrotizing enterocolitis. AJR Am J Roentgenol. 2009 Nov;193(5):1408-13. doi: 10.2214/AJR.08.2306.
- Background: PubMed 15858098Faingold R, Daneman A, Tomlinson G, Babyn PS, Manson DE, Mohanta A, Moore AM, Hellmann J, Smith C, Gerstle T, Kim JH. Necrotizing enterocolitis: assessment of bowel viability with color doppler US. Radiology. 2005 May;235(2):587-94. doi: 10.1148/radiol.2352031718.
- Background: PubMed 16078076Kim WY, Kim WS, Kim IO, Kwon TH, Chang W, Lee EK. Sonographic evaluation of neonates with early-stage necrotizing enterocolitis. Pediatr Radiol. 2005 Nov;35(11):1056-61. doi: 10.1007/s00247-005-1533-4. Epub 2005 Aug 3.
- Background: PubMed 29519542Nakayuenyongsuk W, Christofferson M, Stevenson DK, Sylvester K, Lee HC, Park KT. Point-of-Care Fecal Calprotectin Monitoring in Preterm Infants at Risk for Necrotizing Enterocolitis. J Pediatr. 2018 May;196:98-103.e1. doi: 10.1016/j.jpeds.2017.12.069. Epub 2018 Mar 6.
- Derived from this study: PubMed 35713688Cuna A, Chan S, Jones J, Sien M, Robinson A, Rao K, Opfer E. Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis. Eur J Pediatr. 2022 Aug;181(8):3211-3215. doi: 10.1007/s00431-022-04526-4. Epub 2022 Jun 17.
- 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.
Erin Opfer, DO principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel Ultrasound in people with Enterocolitis, Necrotizing and Premature Infant, run by Children's Mercy Hospital Kansas City 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 1 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: stopped early, as of the sponsor's last update on 10 Jan 2022. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Requiring Medical Management (time frame: First 12 months). The study lists 3 primary outcomes in all. 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 NCT03963011, which also lists 8 linked publications.
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 10 Jan 2022.