Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

Status unconfirmed

Conditions studied: Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy

In brief

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.

Key facts

Study ID

NCT05121753

Run by

Neuroganics LLC

People needed

1000

Starts

2022-02-15

Expected to finish

2024-01-15

Last updated by the study team

2022-02-08

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 10190 Bannock St #102 — Northglenn, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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