Necrotizing Enterocolitis of NewbornECUNancyLyonNCT04719546
Risk Factors of Necrotizing Enterocolitis in Premature Newborns
An observational study of Necrotizing Enterocolitis of Newborn and Risk Factors, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Enterocolitis of Newborn, Risk Factors
- What is being tested?
- Observation of related perinatal factors
- How many people
- 459 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jan 2021to 31 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria. * Premature newborns (< 37 weeks of gestation) having grown up without nectrotizing enterocolitis at the same period of time, in order to associate 2 witness patient to one case patient.
Who may be able to join
- Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
Who cannot join
- Children term born (> 37 weeks of gestation)
- Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon
- Malformation or pre-existing digestive pathology
- Complex or severe malformative pathologies
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU LYON
Bron, 69677
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, 54035
About this study
Official title: Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.
NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
Read more
The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.
Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.
Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.
- Conditions
- Necrotizing Enterocolitis of Newborn, Risk Factors
- Being tested
- Observation of related perinatal factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of related perinatal factorsOther
Data described in Primary outcome measures will be collected in both groups
| Study group | Role | What they receive |
|---|---|---|
| NEC Group | All Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis Receives: Other: Observation of related perinatal factors | |
| Control Group | All Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period Receives: Other: Observation of related perinatal factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Necrotizing enterocolitis (NEC)
Number of infants with NEC at a Bell stage > 1 in Nancy as compared to Lyon
Measured: 10 years
Risk factor of NEC during Pregnancy
Number of infants who had abnormal pregnancy course in each group (defined as the presence of multiple pregnancy; gestational hypertension; Intrauterine Growth Retardation defined as a birth weight below the 10th Centile of Fenton Curves; Abnormal heart rate at the time of delivery)
Measured: 10 years
Gestational age of infants with NEC
Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon
Measured: 10 years
Secondary outcomes (9)
Perinatal risk factor of NEC
Number of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon
Measured: 10 years
Place of birth as risk factor for NEC
Number of outborn infants in Nancy as compared to Lyon
Measured: 10 years
Asphyxia at birth
Number of infants with an APGAR score < 7 in Nancy as compared to Lyon
Measured: 10 years
NEC occurrence
Age of NEC onset in Nancy as compared to Lyon
Measured: 10 years
Gender
Rate of baby boys presenting NEC in Nancy as compared to Lyon
Measured: 10 years
Patent Ductus Arteriosus (PDA)
Number of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon
Measured: 10 years
Feeding
Number of infants for each Type of milk at the point of date in Nancy as compared to Lyon (Mothers own milk versus milk bank versus formula )
Measured: 10 years
Infection
Number of infants treated for infection in Nancy as compared to Lyon
Measured: 10 years
Red Blood Cell transfusion
Number of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start21 Jan 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis of NewbornStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719546
- Sponsor's protocol ID
- 2020PI279
- Acronym
- ECUNancyLyon
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Risk Factors of Necrotizing Enterocolitis in the NICU of Nancy Benchmarking With the NICU of Lyon Over 10 Years
- ClinicalTrials.gov ID
- NCT04719546
- Acronym / sponsor ID
- ECUNancyLyon / 2020PI279
- Conditions
- Necrotizing Enterocolitis of Newborn, Risk Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 22 Jan 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.
With premature newborn increase survival, the risk of serious neonatal morbidity, such as necrotizing enterocolitis (NEC), also increased. NEC affects between 2 to 7% of premature infants including 5 to 22% of newborns weighing less than 1000 g.
NEC is an acquired disease, caused by inflammation of the intestinal lining. It is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
The etiology and physiopathology are multifactorial, complex, and remain poorly understood. The mechanism of the lesions seems to involve factors including immaturity of the intestinal barrier and the immune system, microvascular imbalance, disturbed gut flora and systemic inflammation.
Despite improved knowledge about this disease, the proportion of surviving patients has not improved for several years. It frequently leads to long-term sequelae depending on the severity of the NEC and its treatment.
Early diagnosis and early treatment of NEC may reduce the risk of mortality and morbidity. The aim of this retrospective bi-centric study is to look for risk factors allowing the prediction of NEC in order to prevent and improve the early management of this disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEC Group | – | Other: Observation of related perinatal factorsAll Premature Neonates born in Nancy and Lyon over 10 years and presenting with Necrotizing Enterocolitis |
| Control Group | – | Other: Observation of related perinatal factorsAll Premature Neonates born in Nancy and Lyon over 10 years without Necrotizing Enterocolitis throughout the neonatal period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria. * Premature newborns (< 37 weeks of gestation) having grown up without nectrotizing enterocolitis at the same period of time, in order to associate 2 witness patient to one case patient.
Key inclusion criteria (1 listed)
- Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria.
Key exclusion criteria (4 listed)
- Children term born (> 37 weeks of gestation)
- Necrotizing enterocolitis during an hospitalisation outside the NICU of Nancy or Lyon
- Malformation or pre-existing digestive pathology
- Complex or severe malformative pathologies
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 |
|---|---|---|
| Observation of related perinatal factorsData described in Primary outcome measures will be collected in both groups | Other | Control Group, NEC Group |
Primary outcome
Necrotizing enterocolitis (NEC)
Time frame: 10 years
Number of infants with NEC at a Bell stage > 1 in Nancy as compared to Lyon
Risk factor of NEC during Pregnancy
Time frame: 10 years
Number of infants who had abnormal pregnancy course in each group (defined as the presence of multiple pregnancy; gestational hypertension; Intrauterine Growth Retardation defined as a birth weight below the 10th Centile of Fenton Curves; Abnormal heart rate at the time of delivery)
Gestational age of infants with NEC
Time frame: 10 years
Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon
9 secondary outcomes
Perinatal risk factor of NEC
Time frame: 10 years
Place of birth as risk factor for NEC
Time frame: 10 years
Asphyxia at birth
Time frame: 10 years
NEC occurrence
Time frame: 10 years
Gender
Time frame: 10 years
Patent Ductus Arteriosus (PDA)
Time frame: 10 years
Feeding
Time frame: 10 years
Infection
Time frame: 10 years
Red Blood Cell transfusion
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 of Newborn and Risk Factors, run by Central Hospital, Nancy, France at 2 sites in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Necrotizing enterocolitis (NEC) (time frame: 10 years). The study lists 3 primary outcomes in all. 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 4 Mar 2022.