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临床试验/NCT07490834
NCT07490834Enrolling By Invitation不适用

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

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
200
试验地点
1
主要终点
Complications and Nutritional impact of NEC within the first 5 years of life

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Complications and Nutritional impact of NEC within the first 5 years of life

时间窗: 5 years

* Atopy : cow's milk protein allergy, food allergies, eczema/dermatitis, asthma, allergic rhinitis * Orality disorder : need for specialized follow-up * Statural growth retardation (Height\<-2DS) * Weight growth retardation (Weight\<-2DS) * gastroesophageal reflux disease : need for anti-reflux therapy * Esophagitis : pH metry diagnosis * Transit disorders : Laxatives or anti-diarrhea therapy required * Undernutrition : moderate BMI \< 18.5 or severe BMI \< 17 * Repeat surgery : any stay in the operating room

次要结局

  • Potential risk factors of NEC's complications(5 years)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

LAMIREAU Nathalie

Praticien Hospitalier

Central Hospital, Nancy, France

研究点 (1)

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