Necrotizing enterocolitis

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28Active trials105Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Necrotizing enterocolitis, often called NEC, is a serious condition that mainly affects premature and very low birth weight newborns. In NEC, parts of the intestine (bowel) become inflamed and begin to die. This damage can lead to holes in the intestinal wall, allowing bacteria to leak into the abdomen and bloodstream, which can cause life-threatening infection. NEC most commonly occurs in babies born before 32 weeks of pregnancy or those weighing less than 1,500 grams (about 3.3 pounds) at birth. Symptoms usually appear within the first two to six weeks of life and can develop quickly. Early signs include a swollen or tender belly, feeding intolerance (not being able to keep milk down), bloody stools, and general signs of illness such as low energy, unstable body temperature, and breathing problems. Treatment depends on how severe the condition is. Mild cases may be managed with bowel rest (stopping feedings), intravenous fluids and nutrition, and antibiotics. More severe cases, especially when the bowel has perforated (developed a hole), require emergency surgery to remove the damaged sections of intestine. Despite advances in neonatal care, NEC remains one of the most common and dangerous gastrointestinal emergencies in premature infants. Outcomes have improved with early detection and aggressive treatment, but the condition still carries significant risks of complications and death.

Key symptoms:

Swollen or bloated bellyBelly tenderness when touchedBloody stoolsFeeding intolerance or vomitingGreen or yellow vomit (bile)Lethargy or decreased activityUnstable body temperatureBreathing difficulties or pauses in breathing (apnea)Low heart rate (bradycardia)Redness or discoloration of the belly skinDecreased urine outputLow blood pressureDiarrheaFailure to gain weight

Clinical phenotype terms (34)— hover any for plain English
Food intoleranceHP:0012537Bloody diarrheaHP:0025085Hypoactive bowel soundsHP:0030144GastroschisisHP:0001543
Inheritance

Multifactorial

Caused by a mix of several genes and environmental factors

Age of Onset

Neonatal

Begins at or shortly after birth (first 4 weeks)

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
Mar 2026Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants

The Children's Hospital of Zhejiang University School of Medicine — NA

TrialNOT YET RECRUITING
Feb 2026Administration of Extracellular Vesicles From Donor Human Milk in Preterm Infants

Instituto de Investigacion Sanitaria La Fe

TrialRECRUITING
Dec 2025Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.

Central Hospital, Nancy, France

TrialENROLLING BY INVITATION
Dec 2025Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies

Hayatabad Medical Complex — NA

TrialNOT YET RECRUITING
Nov 2025Mechanisms Affecting the Gut of Preterm Infants Receiving Blood Transfusion With Different Enteral Feed Interventions

Imperial College Healthcare NHS Trust

TrialNOT YET RECRUITING
Aug 2025Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).

Imperial College London

TrialRECRUITING
Jun 2025Multi-strain Probiotics to Prevent Necrotizing Enterocolitis in Very Preterm Infants

University of Calgary — PHASE3

TrialNOT YET RECRUITING
Jun 2025Application of Transcriptome Sequencing Combined With Family-Based Whole Genome Sequencing in Improving Precise Diagnosis of Critically Ill Newborns in Northeast China

The First Hospital of Jilin University

TrialNOT YET RECRUITING
Apr 2025Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota

University Hospital, Clermont-Ferrand — NA

TrialRECRUITING
Mar 2025Study of Normal Intestinal Development and Disease in Premature and Term Neonates

Boston Children's Hospital

TrialRECRUITING

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Necrotizing enterocolitis.

20 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

20 recruitingView all trials with filters →
Phase 31 trial
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Phase 3
Active
PI: Josef Neu, MD (University of Florida College of Medicine, Gainsvi) · Sites: Tucson, Arizona; Little Rock, Arkansas +87 more
Phase 41 trial
NICU Antibiotics and Outcomes Trial
Phase 4
Active
· Sites: Mobile, Alabama; San Diego, California +12 more
Phase 21 trial
RIC-NEC Randomized Controlled Trial
Phase 2
Active
PI: Agostino Pierro, OBE, MD (The Hospital for Sick Children) · Sites: Cincinnati, Ohio; Toronto, Ontario +2 more
N/A3 trials
Milk Temperature Control and Necrotizing Enterocolitis Risk in Extremely Preterm Infants
N/A
Active
PI: Long Long, MD.,PhD (Children's Hospital of Chongqing Medical Universit) · Sites: Chongqing, Chongqing Municipality
Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota
N/A
Actively Recruiting
PI: Maguelonne Pons (University Hospital, Clermont-Ferrand) · Sites: Clermont-Ferrand; Grenoble +3 more
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
N/A
Actively Recruiting
· Sites: Amiens
Other12 trials
Amniotic Fluid & the Preterm Gut
Actively Recruiting
· Sites: Amsterdam; Veldhoven · Age: 1699 yrs
Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
Enrolling by Invitation
· Sites: Nancy, Lorraine
Study of Normal Intestinal Development and Disease in Premature and Term Neonates
Actively Recruiting
PI: Amy O'Connell, MD, PhD (Boston Children's Hospital) · Sites: Boston, Massachusetts · Age: 02 yrs
NETs: Protection or Harm in Neonatal Inflammation or Infection
Actively Recruiting
PI: Christian C Yost, M.D. (University of Utah) · Sites: Salt Lake City, Utah
Antibiotic Exposure on Gut Microbiota and Motility Establishment in Newborns
Active
· Sites: Changchun, Jilin
Do Probiotics Reduce The Risk Of Severe Necrotising Enterocolitis (NEC) In Infants Born Before 32 Weeks Gestation?
Enrolling by Invitation
· Sites: London
Early Predictors of Necrotizing Enterocolitis in Neonates
Actively Recruiting
PI: Oluyinka Olutoye, MD, PhD (Nationwide Children's Hospital) · Sites: Columbus, Ohio
RBC Irradiation, Anemia and Gut Injury
Active
PI: Ravi Patel, MD, MSc (Emory University) · Sites: Atlanta, Georgia; Atlanta, Georgia +1 more
Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).
Actively Recruiting
· Sites: Norwich, Norfolk; Coventry +5 more
Qualitative Study of Surgeons With Prospective Patient Follow-up
Actively Recruiting
PI: Nigel J Hall (University of Southampton) · Sites: Southampton, Hampshire
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
Active
PI: Massimo De Maio (CHU Nimes) · Sites: Nîmes
A Genome-Wide Association Study for Neonatal Diseases
Active
PI: Kathy Chan, Ph. D. (CUHK) · Sites: Hong Kong

Specialists

Showing 25 of 105View all specialists →
NH
Nigel J Hall
WASHINGTON, DC
Specialist
PI on 1 active trial39 Necrotizing enterocolitis publications
DM
David A Kaufman, MD
Specialist
PI on 1 active trial
RM
R. Lawrence Moss, MD
JACKSONVILLE, FL
Specialist
PI on 2 active trials
MP
Maguelonne Pons
Specialist
PI on 1 active trial13 Necrotizing enterocolitis publications
DM
Danny Benjamin, MD, PhD, MPH
Specialist
PI on 1 active trial
LP
Lise Aunsholt, ph.d.
Specialist
PI on 1 active trial
ED
Erika Bariciak, Dr.
Specialist
PI on 1 active trial
MM
Mehmet Yekta Oncel, MD
PORT JEFFERSON, NY
Specialist
PI on 2 active trials
SP
Sherwin Chan, MD, PhD
KANSAS CITY, MO
Specialist
PI on 2 active trials
SM
Suganya Kathiravan, MD
NEW BRUNSWICK, NJ
Specialist
PI on 1 active trial
JM
Josef Neu, MD
GAINESVILLE, FL
Specialist
PI on 4 active trials
AM
Abbot R. Laptook, MD
Birmingham, Alabama
Specialist

Rare Disease Specialist

PI on 11 active trials1 Necrotizing enterocolitis publication
AM
Andreas Repa, MD
Specialist
PI on 2 active trials
MM
Mario A Rojas, MD, MPH
Specialist
PI on 3 active trials
LP
Luigi T Corvaglia, Prof
Specialist
PI on 2 active trials
SM
Sahar Hegazy, MD
Specialist
PI on 1 active trial
AM
Aaron Hamvas, MD
CHICAGO, IL
Specialist
PI on 1 active trial1 Necrotizing enterocolitis publication
MM
Mehmet Yalaz, Prof, MD
Specialist
PI on 1 active trial
RM
Ronald Clyman, MD
SAN FRANCISCO, CA
Specialist
PI on 1 active trial
SM
Sezin Unal, Prof, MD
Specialist
PI on 1 active trial
İM
İlke Mungan Akın, Prof, MD
Specialist
PI on 1 active trial1 Necrotizing enterocolitis publication
QP
Qing Yang, MD, PhD
Specialist
PI on 2 active trials
SM
Sule Yigit, Prof, MD
Specialist
PI on 1 active trial
BM
Betül Acunaş, Prof, MD
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Necrotizing enterocolitis.

Search all travel grants →NORD Financial Assistance ↗

Community

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Latest news about Necrotizing enterocolitis

Disease timeline:

New recruiting trial: Predictive Diagnosis of Ulcero-Necrotizing EnteroColitis in Premature Babies Using an Artificial Intelligence Approach Based on Early Analysis of the Fecal Microbiota

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Primary Anastomosis Versus Enterostomy in the Surgical Treatment of Necrotising Enterocolitis

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Intestinal Lavage to Promote Enteral Feeding and Prevent Necrotizing Enterocolitis in Extremely Preterm Infants

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: WithHolding Enteral Feeds Around Blood Transfusion (International)

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Qualitative Study of Surgeons With Prospective Patient Follow-up

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Health-Related Quality-of-Life and Household Financial and Wellbeing Impacts of Prematurity and Necrotising Enterocolitis (NEC).

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Study of Normal Intestinal Development and Disease in Premature and Term Neonates

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis

A new clinical trial is recruiting patients for Necrotizing enterocolitis

New recruiting trial: Early Predictors of Necrotizing Enterocolitis in Neonates

A new clinical trial is recruiting patients for Necrotizing enterocolitis

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

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Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Questions for your doctor

Bring these to your next appointment

  • Q1.How severe is my baby's NEC, and what stage is it?,Will my baby need surgery, and what are the risks?,How much intestine was affected or removed, and will this cause long-term problems?,When can we start feeding my baby again, and what type of milk or formula is best?,What are the signs of complications I should watch for after discharge?,Will my baby need developmental follow-up, and how often?,Is there anything I can do to reduce the risk of NEC happening again or getting worse?

Common questions about Necrotizing enterocolitis

What is Necrotizing enterocolitis?

Necrotizing enterocolitis, often called NEC, is a serious condition that mainly affects premature and very low birth weight newborns. In NEC, parts of the intestine (bowel) become inflamed and begin to die. This damage can lead to holes in the intestinal wall, allowing bacteria to leak into the abdomen and bloodstream, which can cause life-threatening infection. NEC most commonly occurs in babies born before 32 weeks of pregnancy or those weighing less than 1,500 grams (about 3.3 pounds) at birth. Symptoms usually appear within the first two to six weeks of life and can develop quickly. Early

How is Necrotizing enterocolitis inherited?

Necrotizing enterocolitis follows a multifactorial inheritance pattern. Genetic counseling can help families understand recurrence risk and testing options.

At what age does Necrotizing enterocolitis typically begin?

Typical onset of Necrotizing enterocolitis is neonatal. Age of onset can vary across affected individuals.

Are there clinical trials for Necrotizing enterocolitis?

Yes — 20 recruiting clinical trials are currently listed for Necrotizing enterocolitis on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Necrotizing enterocolitis?

25 specialists and care centers treating Necrotizing enterocolitis are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.