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Condition (MeSH)

Enterocolitis, Necrotizing

ClinicalTrials.gov lists 222 trials for Enterocolitis, Necrotizing or a narrower condition beneath it. Coordinación de Investigación en Salud, Mexico has the most among industry and government lead sponsors, with 4.

MeSH D020345 Digestive System Diseases C06 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 12 Phase 1/2 Phase 1/2 8 Phase 2 Phase 2 17 Phase 2/3 Phase 2/3 3 Phase 3 Phase 3 14 Phase 4 Phase 4 6 Not applicable Not applicable 68 Observational Observational 94 Phase 1 Phase 1 12 Phase 1/2 Phase 1/2 8 Phase 2 Phase 2 17 Phase 2/3 Phase 2/3 3 Phase 3 Phase 3 14 Phase 4 Phase 4 6 Not applicable Not applicable 68 Observational Observational 94

Trials per phase (log scale)

222 of the 222 trials are tagged with Enterocolitis, Necrotizing itself; the rest are tagged with a narrower condition beneath it.

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The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Enterocolitis, Necrotizing trials start? (29)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 16

1993: 1 trials (Phase 3 1) 1997: 1 trials (Not applicable 1) 1999: 1 trials (Not applicable 1) 2000: 1 trials (Observational 1) 2001: 1 trials (Observational 1) 2003: 4 trials (Observational 2, Phase 2 1, Phase 1 1) 2004: 1 trials (Observational 1) 2005: 4 trials (Phase 3 1, Phase 2 3) 2006: 8 trials (Observational 4, Not applicable 2, Phase 3 1, Phase 2/3 1) 2007: 4 trials (Observational 2, Not applicable 2) 2008: 5 trials (Observational 1, Not applicable 2, Phase 3 1, Phase 1/2 1) 2009: 9 trials (Observational 2, Not applicable 5, Phase 2 1, Phase 1 1) 2010: 12 trials (Observational 6, Not applicable 2, Phase 2 2, Phase 1/2 1, Phase 1 1) 2011: 7 trials (Observational 2, Not applicable 1, Phase 3 2, Phase 2/3 1, Phase 1 1) 2012: 10 trials (Observational 2, Not applicable 2, Phase 3 2, Phase 2 2, Phase 1/2 2) 2013: 10 trials (Observational 3, Not applicable 5, Phase 3 1, Phase 2 1) 2014: 9 trials (Observational 2, Not applicable 2, Phase 4 1, Phase 2 2, Phase 1 2) 2015: 10 trials (Observational 5, Not applicable 4, Phase 1 1) 2016: 6 trials (Observational 2, Not applicable 1, Phase 2 2, Phase 1/2 1) 2017: 11 trials (Observational 6, Not applicable 4, Phase 2 1) 2018: 14 trials (Observational 7, Not applicable 5, Phase 4 1, Phase 3 1) 2019: 10 trials (Observational 3, Not applicable 2, Phase 4 1, Phase 3 1, Phase 2/3 1, Phase 1/2 1, Phase 1 1) 2020: 6 trials (Observational 3, Not applicable 2, Phase 2 1) 2021: 15 trials (Observational 9, Not applicable 2, Phase 4 1, Phase 3 1, Phase 1/2 1, Phase 1 1) 2022: 16 trials (Observational 7, Not applicable 8, Phase 3 1) 2023: 10 trials (Observational 3, Not applicable 4, Phase 4 1, Phase 2 1, Phase 1 1) 2024: 10 trials (Observational 5, Not applicable 4, Phase 1/2 1) 2025: 14 trials (Observational 9, Not applicable 2, Phase 4 1, Phase 3 1, Phase 1 1)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 11
2025 14
2024 10
2023 10
2022 16
2021 15
2020 6
2019 10
2018 14
2017 11

Showing 10 of 29 earlier years.

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Forecast of the full-year count, planned starts included, not rows of this table: about 13 trials starting in 2026 and about 12 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 12 trials still running at the 2026-10-09 snapshot; registered median of 28 months across 116 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Enterocolitis, Necrotizing trials in? (8)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 12
Phase 1/2 8
Phase 2 17
Phase 2/3 3
Phase 3 14
Phase 4 6
Not applicable 68
Observational 94

How many Enterocolitis, Necrotizing trials are recruiting? (8)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 14
Recruiting 20
Enrolling by invitation 2
Active, not recruiting 11
Completed 98

Showing 5 of 8 statuses.

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Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Enterocolitis, Necrotizing trials? (2)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Coordinación de Investigación en Salud, Mexico 4
NICHD Neonatal Research Network 3

Which drugs are being tested for Enterocolitis, Necrotizing? (5)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Breast milk 3
Lactobacillus reuteri 3
Bovine Colostrum 3
Pentoxifylline 2
Docosahexaenoic Acid 2

Interventions as named in the registry (10)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Probiotics 6
Probiotic 3
Double distilled water 2
No Intervention -- Observational study 2
Metronidazol 2

Showing 5 of 10 interventions.

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These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Enterocolitis, Necrotizing trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Severe morbidity or death 107 1
Necrotizing enterocolitis neonatal 105 1
Neonatal sepsis 48 1
necrotizing enterocolitis 36 1
Death 30 2

Showing 5 of 10 adverse events.

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Which publications cover Enterocolitis, Necrotizing? (451)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Surgical decision-making strategies in preterm neonates with necrotizing enterocolitis: A randomized controlled clinical trial. Cirugia pediatrica : organo oficial de la Sociedad Espanola de Cirugia Pediatrica 2026 Yes
Lactate/albumin ratio as a prognostic biomarker for in-hospital mortality in pediatric patients with necrotizing enterocolitis. BMC pediatrics 2025 Yes
Dysbiotic Microbiota in Necrotizing Enterocolitis: Insights into Pathogenesis, Treatment, and Prevention. Gastroenterology clinics of North America 2025 Yes
A comparative study of serum and fecal calprotectin levels in necrotizing enterocolitis. Jornal de pediatria 2025 Yes
Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. The Cochrane database of systematic reviews 2024 Yes

Showing 5 of 451 publications.

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Prevalence (3)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Necrotizing enterocolitis Point prevalence 1-5 / 10 000 Worldwide Not stated Exact
Necrotizing enterocolitis Point prevalence 1-5 / 10 000 Worldwide Not stated Unspecified
Necrotizing enterocolitis Point prevalence 1-5 / 10 000 Worldwide Not stated Exact

Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Necrotizing enterocolitis 391673 Exact Orphadata Science knowledge files, Product 1
Necrotizing enterocolitis 391673 Exact Orphanet Rare Disease Ontology (ORDO)

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: sub-conditions in mesh.

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