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| Name | Class |
|---|---|
| Ramos Law Injury Firm | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey investigating Infant formula feeding in newborns | Dietary Supplement | A database will be created that allows individuals to register and enter information about the premature infant's feeding history and symptoms/ medical history. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant formulas and increased risk for NEC survey | A survey is given to allow parents/ guardians or health care workers to describe the events leading up to the development of NEC in their newborn. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Newborn infants fed formula and experienced symptoms of NEC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donald Cooper, Ph.D. | Contact | 720.580.8343 | NECstudy@protonmail.com | |
| Joe Ramos, MD/JD | Contact | 303.733.6353 |
| Name | Affiliation | Role |
|---|---|---|
| Don Cooper, Ph.D. | Neuroganics LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10190 Bannock St #102 | Recruiting | Northglenn | Colorado | 80260 | United States |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D000071074 | Neonatal Sepsis |
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D007410 |
| Intestinal Diseases |
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |