N/A
N=169
Comparative Effectiveness Trial for Diagnosis of Necrotizing Enterocolitis
Necrotizing Enterocolitis
Bottom Line
View on ClinicalTrials.gov: NCT05573113 ↗Enrolled (actual)
169
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Days to Full Enteral Feeds: Extended Rule Out Group — 10.1; 4.9 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bowel Ultrasound (Diagnostic_test); Abdominal radiograph (Diagnostic_test)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days to Full Enteral Feeds: Extended Rule Out Group |
10.1; 4.9 | — |
| PRIMARY Days to Full Enteral Feeds: Quick Rule Out Group |
0.4; 1.0 | — |
| PRIMARY Days to Full Enteral Feeds: NEC Ruled In |
17.0; 17.6 | — |
| SECONDARY Days to End Bowel Rest: Extended Rule Out Group |
2.6; 2.1 | — |
| SECONDARY Days to End Bowel Rest: Quick Rule Out Group |
0.2; 0.4 | — |
| SECONDARY Days to End Bowel Rest: NEC Ruled In |
8.7; 8.7 | — |
| SECONDARY Days to End Antibiotics: Extended Rule Out |
1.6; 1.5 | — |
| SECONDARY Days to End Antibiotics: Quick Rule Out |
0.1; 0.8 | — |
| SECONDARY Days to End Antibiotics: NEC Rule In |
8.4; 7.5 | — |
Summary
The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.
Eligibility Criteria
Inclusion Criteria
- Admitted to the NICU at CMKC or KUMC
- With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist
Exclusion Criteria
- Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed
Data sourced from ClinicalTrials.gov (NCT05573113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.