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Long-term Nutritional Impact of Necrotizing Enterocolitis in Premature Newborns. (PremGrowth)

C

Central Hospital, Nancy, France

Status

Invitation-only

Conditions

Oral Disorders
Necrotising Enterocolitis Neonatal
Nutrition Disorder, Child

Treatments

Other: Observation of related perinatal and postnatal factors

Study type

Observational

Funder types

Other

Identifiers

NCT07490834
2025PI067

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

NEC Group
Description:
All Premature Neonates born in Nancy over 10 years and presenting NEC
Treatment:
Other: Observation of related perinatal and postnatal factors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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