NCT05121753

Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Neuroganics LLC · Industry
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-15
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2021-11-16
• Last updated: 2022-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study