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Набор по приглашению NCT07490834

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

Наблюдательное Necrotising Enterocolitis Neonatal Nutrition Disorder, Child Oral Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observation of related perinatal and postnatal factors.
Кому может быть актуально
Состояния в реестре: Necrotising Enterocolitis Neonatal, Nutrition Disorder, Child, Oral Disorders. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Evaluate the Long-term Nutritional Impact of Necrotizing Enterocolitis at 5 Years, in Premature Newborns in the NICU of NANCY Over 10 Years.

Обзор

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.

Вмешательства

  • Другое Observation of related perinatal and postnatal factors
    Data described in Primary outcome measures will be collected in this group

Первичные конечные точки

  • Complications and Nutritional impact of NEC within the first 5 years of life [Срок оценки: 5 years]
Вторичные конечные точки (1)
  • Potential risk factors of NEC's complications [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Maternité Régionale Universitaire de Nancy — Nancy

Идентификаторы

NCT: NCT07490834 · 2025PI067

Первоисточники (государственные реестры)

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