Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121753
• Other study ID #: NEC_1121
• Status: Recruiting
• Start date: February 15, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: February 2022
• Source: Neuroganics LLC
• Contact: Donald Cooper, Ph.D.
• Phone: 720.580.8343
• Email: NECstudy[@]protonmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Milk Hypersensitivity
• Necrotizing Enterocolitis
• Necrotizing Enterocolitis of Newborn
• Neonatal Sepsis
• Sepsis Newborn

Intervention

Dietary Supplement:
• Survey investigating Infant formula feeding in newborns
A database will be created that allows individuals to register and enter information about the premature infant's feeding history and symptoms/ medical history.

Locations

Country	Name	City	State
United States	10190 Bannock St #102	Northglenn	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Neuroganics LLC	Ramos Law Injury Firm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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