Necrotizing EnterocolitisNCT05573113

Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis

A study testing Bowel Ultrasound and Abdominal radiograph in people with Necrotizing Enterocolitis, run by Children's Mercy Hospital Kansas City at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings. Read more about this study

Who is it for?: Ages Up to 1 year
Conditions the study is for: Necrotizing Enterocolitis
What is being tested?: Bowel Ultrasound and Abdominal radiograph
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: 2 sitesUnited States
Study dates: 1 Nov 2022to 18 Sep 2025
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 1 year
All sexes
No healthy volunteers
Child

Who may be able to join

Admitted to the NICU at CMKC or KUMC
With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

Who cannot join

Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Kansas Medical Center
Kansas City, Kansas, 66160
Children's Mercy Kansas City
Kansas City, Missouri, 64086

Other trials in United States

About this study

Official title: Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Read the detailed description

Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.

Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.

Conditions: Necrotizing Enterocolitis
Being tested: Bowel Ultrasound, Abdominal radiograph
Medical subject headings: Enterocolitis, Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bowel UltrasoundDiagnostic test
Bowel Ultrasound
Abdominal radiographDiagnostic test
Abdominal radiograph

Study groups in NCT05573113
Study group	Role	What they receive
AXR Arm 1	Active comparator	Abdomen Radiograph Receives: Diagnostic Test: Abdominal radiograph
AXR + BUS Arm 2	Active comparator	Abdomen Radiograph + Bowel Ultrasound Receives: Diagnostic Test: Bowel Ultrasound; Diagnostic Test: Abdominal radiograph

What is being measured

The primary outcome is the main question the study is designed to answer.

Days to Full Enteral Feeds: Extended Rule Out Group
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Measured: Within 30 days of NEC concern
Days to Full Enteral Feeds: Quick Rule Out Group
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Measured: Within 30 days of NEC concern
Days to Full Enteral Feeds: NEC Ruled In
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Measured: Within 30 days of NEC concern

Secondary outcomes (6)

Days to End Bowel Rest: Extended Rule Out Group
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Measured: within 14 days of NEC concern
Days to End Bowel Rest: Quick Rule Out Group
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Measured: within 14 days of NEC concern
Days to End Bowel Rest: NEC Ruled In
Number of days infants were kept nil per os (without enteral feeds) following concern for NEC
Measured: within 14 days of NEC concern
Days to End Antibiotics: Extended Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Measured: within 14 days of NEC concern
Days to End Antibiotics: Quick Rule Out
Number of days infants received antibiotic therapy initiated for NEC concern
Measured: within 14 days of NEC concern
Days to End Antibiotics: NEC Rule In
Number of days infants received antibiotic therapy initiated for NEC concern
Measured: within 14 days of NEC concern

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202218 Sep 2025

First posted10 Oct 2022
Study start1 Nov 2022
Primary completion23 Sep 2024
Study completion18 Sep 2025

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.
Other trials for Necrotizing EnterocolitisStudies 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
Masking: None (open label)
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05573113
Sponsor's protocol ID: STUDY00002293
Status last verified: Nov 2025
First submitted: 23 Sep 2022
Last updated: 21 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Recruiting
WithHolding Enteral Feeds Around Blood Transfusion (International)
Necrotizing Enterocolitis

All Necrotizing Enterocolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
ClinicalTrials.gov ID: NCT05573113
Acronym / sponsor ID: STUDY00002293
Conditions: Necrotizing Enterocolitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Collaborators: University of Kansas Medical Center, American College of Radiology
Study start: 1 Nov 2022 (actual)
Primary completion: 23 Sep 2024 (actual)
Study completion: 18 Sep 2025 (actual)
First posted: 10 Oct 2022 (actual)
Results: Posted 21 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AXR Arm 1	Active comparator	Diagnostic Test: Abdominal radiographAbdomen Radiograph
AXR + BUS Arm 2	Active comparator	Diagnostic Test: Bowel Ultrasound, Diagnostic Test: Abdominal radiographAbdomen Radiograph + Bowel Ultrasound

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Admitted to the NICU at CMKC or KUMC
With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

Key exclusion criteria (1 listed)

Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

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 UltrasoundBowel Ultrasound	Diagnostic test	AXR + BUS Arm 2
Abdominal radiographAbdominal radiograph	Diagnostic test	AXR + BUS Arm 2, AXR Arm 1

Primary outcome

Days to Full Enteral Feeds: Extended Rule Out Group
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Days to Full Enteral Feeds: Quick Rule Out Group
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds
Days to Full Enteral Feeds: NEC Ruled In
Time frame: Within 30 days of NEC concern
Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

6 secondary outcomes

Days to End Bowel Rest: Extended Rule Out Group
Time frame: within 14 days of NEC concern
Days to End Bowel Rest: Quick Rule Out Group
Time frame: within 14 days of NEC concern
Days to End Bowel Rest: NEC Ruled In
Time frame: within 14 days of NEC concern
Days to End Antibiotics: Extended Rule Out
Time frame: within 14 days of NEC concern
Days to End Antibiotics: Quick Rule Out
Time frame: within 14 days of NEC concern
Days to End Antibiotics: NEC Rule In
Time frame: within 14 days of NEC concern

Results and safety

Results posted to the registry on 21 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abdominal Radiographs Only (AXR)	92	92
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)	77	77

Primary outcome: Days to Full Enteral Feeds: Extended Rule Out Group

Time frame: Within 30 days of NEC concern. Mean (Standard Deviation). Unit: days

Measure	Abdominal Radiographs Only (AXR) n = 42	Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) n = 28
Value	10.1 (10.9)	4.9 (4.5)

Population analysed: Extended Rule Out Group: Infants with clinical concern for NEC who were ultimately not diagnosed with NEC but required more than one AXR to confidently rule out the disease. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.

Primary outcome: Days to Full Enteral Feeds: Quick Rule Out Group

Time frame: Within 30 days of NEC concern. Mean (Standard Deviation). Unit: days

Measure	Abdominal Radiographs Only (AXR) n = 40	Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) n = 23
Value	0.4 (1.4)	1.0 (2.4)

Population analysed: Quick Rule Out Group: Infants with suspected NEC in whom the diagnosis was excluded after a single AXR. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.

Primary outcome: Days to Full Enteral Feeds: NEC Ruled In

Time frame: Within 30 days of NEC concern. Mean (Standard Deviation). Unit: days

Measure	Abdominal Radiographs Only (AXR) n = 32	Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS) n = 34
Value	17.0 (8.6)	17.6 (9.0)

Population analysed: NEC Ruled In Group: Infants with suspected NEC who were diagnosed with NEC based on clinical, laboratory, and imaging findings. Infants who crossed over to a different imaging strategy were analyzed according to the arm to which they were originally randomized, following an intention-to-treat approach.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Until discharge from hospital or death, up to a maximum of 180 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abdominal Radiographs Only (AXR)	0 of 66 (0%)	0 of 66 (0%)	5 of 66
Abdominal Radiographs plus Bowel Ultrasound (AXR + BUS)	0 of 74 (0%)	0 of 74 (0%)	8 of 74
Cross-Over to AXR + BUS	0 of 26 (0%)	0 of 26 (0%)	1 of 26
Cross-Over to AXR only	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): * Cross-over between study arms occurred. * Study conducted at only two sites; generalizability may be limited. * Some analyses underpowered due to smaller sample size than anticipated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Necrotizing Enterocolitis

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)
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Recruiting
WithHolding Enteral Feeds Around Blood Transfusion (International)
Necrotizing Enterocolitis

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.

Sherwin Chan, MD, PhD principal investigator

Children's Mercy Kansas City

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bowel Ultrasound and Abdominal radiograph in people with Necrotizing Enterocolitis, run by Children's Mercy Hospital Kansas City at 2 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 2 inclusion and 1 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 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 21 Nov 2025). 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?

Days to Full Enteral Feeds: Extended Rule Out Group (time frame: Within 30 days of NEC concern). 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 NCT05573113.

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 Nov 2025.