Recruiting

Observational Study

Sponsor:

Neuroganics LLC

Code:

NCT05121753

Conditions

Necrotizing Enterocolitis

Necrotizing Enterocolitis of Newborn

Sepsis Newborn

Cows Milk Allergy

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Survey investigating Infant formula feeding in newborns

Study Details

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.

Conditions

Necrotizing Enterocolitis

Necrotizing Enterocolitis of Newborn

Sepsis Newborn

Cows Milk Allergy

Study ID

NCT05121753

Start date

Feb 15, 2022

Status verified date

Feb, 2022

Completion date

Jan 15, 2024

Anticipated

Primary completion date

Jan 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Infant formulas and increased risk for NEC survey [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Donald Cooper, Ph.D.

720.580.8343NECstudy@protonmail.com

Joe Ramos, MD/JD

303.733.6353

Locations

10190 Bannock St #102

Recruiting

Northglenn, Colorado, United States, 80260

Contacts

Donald Cooper, Ph.D.

drdon@neuroganicslabs.com

More Information

Sponsor

Neuroganics LLC

Last update posted

Feb 8, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neuroganics LLC on 2022-02-08.