Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Neuroganics

Status: Unknown

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

Treatments: Dietary Supplement: Survey investigating Infant formula feeding in newborns

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05121753

NEC_1121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 day to 2 years old

Volunteers: No Healthy Volunteers

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.