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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04719546
Other study ID # 2020PI279
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 21, 2021
Est. completion date August 31, 2021

Study information

Verified date March 2022
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 459
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation of related perinatal factors
Data described in Primary outcome measures will be collected in both groups

Locations

Country Name City State
France CHU LYON Bron
France Maternite Regionale Universitaire CHRU NANCY Nancy Lorraine

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Necrotizing enterocolitis (NEC) Number of infants with NEC at a Bell stage > 1 in Nancy as compared to Lyon 10 years
Primary 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) 10 years
Primary Gestational age of infants with NEC Gestational age in weeks of infants presenting with NEC in Nancy as compared to Lyon 10 years
Secondary Perinatal risk factor of NEC Number of infants who did not receive antenatal maturation by steroids in Nancy as compared to Lyon 10 years
Secondary Place of birth as risk factor for NEC Number of outborn infants in Nancy as compared to Lyon 10 years
Secondary Asphyxia at birth Number of infants with an APGAR score < 7 in Nancy as compared to Lyon 10 years
Secondary NEC occurrence Age of NEC onset in Nancy as compared to Lyon 10 years
Secondary Gender Rate of baby boys presenting NEC in Nancy as compared to Lyon 10 years
Secondary Patent Ductus Arteriosus (PDA) Number of enfants presenting a PDA requiring treatment in Nancy as compared to Lyon 10 years
Secondary 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 ) 10 years
Secondary Infection Number of infants treated for infection in Nancy as compared to Lyon 10 years
Secondary Red Blood Cell transfusion Number of infants who required a transfusion before the occurence of NEC in Nancy as compared to Lyon 10 years
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