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Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Study Purpose

Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality. Early diagnosis and early treatment interventions may reduce the risk of mortality and morbidity. The Primary goal of this observational study is to gather survey data to establish a national database of NEC in newborns in order to better understand the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Day - 2 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Infants born after 2018.
  • - Newborns that have been diagnosed with NEC and have consumed infant formula.
  • - Infants whose death resulted from NEC or complications thereof.

Exclusion Criteria:

  • - Infants who were born prior to 2019.
  • - Newborns who have been fed exclusively on breast milk.
  • - Subjects lacking medical records or who cannot provide a medical history.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Neuroganics LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Don Cooper, Ph.D.
Principal Investigator Affiliation Neuroganics LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
Additional Details

NEC affects between 2 to 7% of premature infants. It is is an acquired disease, caused, in part by inflammation of the intestinal lining. NEC is the most common life-threatening gastrointestinal emergency of prematurity and it is associated with significant morbidity and mortality. Studies have linked the consumption of non-breast milk, commercial infant formula (made from cow's milk) or formula-derived nutrition with increased risk of NEC compared to consumption of human breast milk. The mechanism of the NEC lesions appears to involve factors including allergic reaction to the infant formulas containing cow's milk, immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation that is hypothesized to be exacerbated by infant formula consumption. The primary goal of this National observational study is to gather survey data in order to establish a database of NEC in newborns to gain a better understanding of the risk factors underlying NEC. Survey data will be used along with a medical history to identify the mechanism(s) underlying the increased prevalence of NEC in non-breast fed, formula fed premature infants.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

10190 Bannock St #102, Northglenn, Colorado




10190 Bannock St #102

Northglenn, Colorado, 80260

Site Contact

Donald Cooper, Ph.D.



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