Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

NCT05121753 | Unknown FDA Drug

• 1 other identifier: NEC_1121
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Necrotizing Enterocolitis; Necrotizing Enterocolitis of Newborn; Sepsis Newborn; Cows Milk Allergy

Outcome Measures

Primary Outcomes (1)

• Infant formulas and increased risk for NEC survey

  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

Interventions

Survey investigating Infant formula feeding in newborns DIETARY_SUPPLEMENT

A database will be created that allows individuals to register and enter information about the premature infant's feeding history and symptoms/ medical history.

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborn infants fed formula and experienced symptoms of NEC.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuroganics LLC: lead
• Ramos Law Injury Firm: collaborator

Study Sites (1)

10190 Bannock St #102

Northglenn, Colorado, 80260, United States

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Neonatal Sepsis; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Don Cooper, Ph.D.

  Neuroganics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald Cooper, Ph.D.

CONTACT

720.580.8343; NECstudy@protonmail.com

Joe Ramos, MD/JD

CONTACT

303.733.6353

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: February 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2024
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

US (1)