Isolated Rectal Bleeding in Newborns : Allergic Proctocolitis or Neonatal Colitis Transient - COLON Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia.
研究概览
简要总结
Prospective observational pilot study evaluating the frequency of cow's milk protein allergic prococolitis in newborns hospitalized in neontal medicine at the university hospital of Nice who presented rectal bleeding.
详细描述
Inclusion of all newborns in the neonatal medicine department at Nice University Hospital with isolated rectal bleeding.
A note of information and non-opposition will be presented and given to the biological mother. She has the right to object to this study, on her own initiative, at any time.
Collection of data relating to the newborn during hospitalization, the results of the clinical examination and the systematic check-up carried out in accordance with standard practice, and data at discharge.
Follow-up of the newborn to determine the cause of rectal bleeding and therefore the frequency of procolitis allergic to cow's milk proteins.
Prospective observational study of current practices without any intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborns ≤ 28 days corrected age or ≤ 44 amenorrhea weeks corrected age hospitalized in neonatal medicine with isolated rectorrhagia;
- •Affiliated to social security ;
- •Presenting isolated rectorrhagia defined as rectorrhagia without hematemesis/ repeated vomiting/ tense or distended abdomen/ apathy/ apnea/ bradycardia or signs of severity (tachycardia, desaturation, poor coloration);
- •After obtaining the biological mother's non-objection;
排除标准
- •All newborns with ulcerative enterocolitis, congenital digestive malformations or rectorrhagia following digestive surgery;
- •Opposition to participation in research involving the human person.
结局指标
主要结局
Number of newborns allergic to cow's milk protein and hospitalized in neonatal medicine at Nice University Hospital with isolated rectorrhagia.
时间窗: 3 years
The main objective of this study is to determine the number of newborns presenting real allergic proctocolitis to cow's milk protein among all newborns hospitalised in neonatal medicine who presented with isolated rectal bleeding in order to determine the frequency of this pathology. If rectal bleeding disappears when cow's milk proteins are eliminated and reappears when cow's milk proteins are reintroduced, the diagnosis of allergic proctocolitis to cow's milk proteins will be confirmed. In other cases, newborns will be considered to have had transient neonatal colitis. Then this study will determine the frequency of these two diseases in the population study.
次要结局
- Identify risk factors for developing transient neonatal colitis.(3 years)