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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05121753
Study type Observational
Source Neuroganics LLC
Contact Donald Cooper, Ph.D.
Phone 720.580.8343
Email NECstudy@protonmail.com
Status Recruiting
Phase
Start date February 15, 2022
Completion date January 15, 2024
View Details
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