Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observation of related perinatal and postnatal factors.
- Who it may be relevant to
- Registry conditions: Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluate the Long-term Nutritional Impact of Necrotizing Enterocolitis at 5 Years, in Premature Newborns in the NICU of NANCY Over 10 Years.
Overview
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 etiologies and pathophysiology of this disease are multifactorial and complex, and remain poorly understood. The imputability of associated factors is difficult to establish. The mechanism of the lesions observed seems to involve many factors, including immaturity of the intestinal barrier and immune system, microvascular imbalance, disturbed intestinal flora and systemic inflammation. Survivors frequently have long-term sequelae that depend on the severity of ECUN and its treatment. Up to 20% of patients develop secondary intestinal stenosis requiring surgical intervention. In addition, around 25% of patients treated for ECUN develop short small bowel syndrome. Studies also showed that patients with ECUN were at greater risk of developing growth retardation and neurodevelopmental delay. Early and regular medical follow-up could reduce the risk of mortality and morbidity. It therefore seems essential to be able to predict the risk of long-term complications of enterocolitis in our department, in order to detect and manage them as early as possible.
Interventions
- Other Observation of related perinatal and postnatal factors
Data described in Primary outcome measures will be collected in this group
Primary outcome measures
- Complications and Nutritional impact of NEC within the first 5 years of life [Time frame: 5 years]
Secondary outcome measures (1)
- Potential risk factors of NEC's complications [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Premature newborns (< 37 weeks of gestation) having done a necrotizing enterocolitis stage II or III according to Bell's criteria, in the NICU of Nancy between January 2014 and December 2023.
Exclusion criteria
- Children term born (> 37 weeks of gestation)
- Necrotizing enterocolitis during an hospitalisation outside of the NICU of Nancy
- Malformation or pre-existing digestive pathology
- Complex or severe malformative pathologies
- Parents objecting with the collection of their child's data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Maternité Régionale Universitaire de Nancy — Nancy
Identifiers
NCT: NCT07490834 · 2025PI067