Clinical Trial

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

Study acronym: PremGrowth
Enrolling by Invitation
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Record status
This record was last updated March 24, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
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 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.
Trial Details
NCT Number NCT07490834
Lead Sponsor Central Hospital, Nancy, France
Conditions Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders
Enrollment 200 participants
Start Date 2025-12-10
Primary Completion 2026-05 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-24