Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

February 7, 2022 updated by: Neuroganics LLC

Infant Formula Feeding and the Etiology of Necrotizing Enterocolitis in Newborns Survey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Joe Ramos, MD/JD
  • Phone Number: 303.733.6353

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Newborn infants fed formula and experienced symptoms of NEC.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant formulas and increased risk for NEC survey
Time Frame: 2 years
A survey is given to allow parents/ guardians or health care workers to describe the events leading up to the development of NEC in their newborn.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuroganics LLC

Collaborators

Ramos Law Injury Firm

Investigators

  • Principal Investigator: Don Cooper, Ph.D., Neuroganics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2022

Primary Completion (Anticipated)

January 15, 2024

Study Completion (Anticipated)

January 15, 2024

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 15, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEC_1121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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