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Infant Formula Feeding and Necrotizing Enterocolitis in Newborns

NCT05121753 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-02-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ramos Law Injury Firm

    collaborator UNKNOWN

  • Neuroganics LLC

    lead INDUSTRY

Principal Investigators

  • Don Cooper, Ph.D. · Neuroganics LLC

Eligibility

Min Age
1 Day
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2024-01-15
Completion
2024-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05121753 on ClinicalTrials.gov