Clinical trial NCT05121753: Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Official title: Infant Formula Feeding and the Etiology of Necrotizing Enterocolitis in Newborns Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis
Necrotizing Enterocolitis of Newborn
Sepsis Newborn
Cows Milk Allergy
Lead sponsor: Neuroganics LLC
Sponsor class: INDUSTRY
Collaborators: name: Ramos Law Injury Firm
First posted: 2021-11-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Newborn infants fed formula and experienced symptoms of NEC.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infant formulas and increased risk for NEC survey
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Northglenn
country: United States
facility: 10190 Bannock St #102
state: Colorado
Study officials:
affiliation: Neuroganics LLC
name: Don Cooper, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: