Necrotizing EnterocolitisNCT05121753
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
An observational study of Necrotizing Enterocolitis and Necrotizing Enterocolitis of Newborn, run by Neuroganics LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn
- What is being tested?
- Survey investigating Infant formula feeding in newborns
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 15 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants fed formula and experienced symptoms of NEC.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Joe Ramos, MD/JD contact
United States1 site, 1 recruiting
- Recruiting
10190 Bannock St #102
Northglenn, Colorado, 80260
Donald Cooper, Ph.D., drdon@neuroganicslabs.com
About this study
Official title: Infant Formula Feeding and the Etiology of Necrotizing Enterocolitis in Newborns Survey
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.
Read the 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.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Being tested
- Survey investigating Infant formula feeding in newborns
- Medical subject headings
- Enterocolitis, Necrotizing, Neonatal Sepsis, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey investigating Infant formula feeding in newbornsDietary 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Feb 2022 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuroganics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ramos Law Injury Firm
- Responsible party
- Sponsor
- Investigators
- Don Cooper, Ph.D., Principal investigator, Neuroganics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121753
- Sponsor's protocol ID
- NEC_1121
- Status last verified
- Feb 2022
- First submitted
- 4 Nov 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Formula Feeding and the Etiology of Necrotizing Enterocolitis in Newborns Survey
- ClinicalTrials.gov ID
- NCT05121753
- Acronym / sponsor ID
- NEC_1121
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Neuroganics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ramos Law Injury Firm
- Study start
- 15 Feb 2022 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants fed formula and experienced symptoms of NEC.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey investigating Infant formula feeding in newbornsA database will be created that allows individuals to register and enter information about the premature infant's feeding history and symptoms/ medical history. | Dietary supplement | – |
Primary outcome
Infant formulas and increased risk for NEC survey
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Ramos, MD/JD contact
Don Cooper, Ph.D. principal investigator
Neuroganics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis and Necrotizing Enterocolitis of Newborn, run by Neuroganics LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald Cooper, Ph.D. (720.580.8343, NECstudy@protonmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant formulas and increased risk for NEC survey (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.