Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis. (AlisNEC)
Allergy Risk and Sensitization Following Necrotizing Enterocolitis
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Infants born in our hospital and diagnosed with NEC during the study period.
- Age-matched control infants born in our hospital during the same period but without NEC diagnosis.
Written and verbal informed consent obtained from at least one parent.
-
Exclusion Criteria:
- Infants whose parents did not provide written or verbal consent.
- Infants with major congenital anomalies.
- Infants with chromosomal disorders.
- Infants with gastrointestinal malformations (e.g., duodenal atresia, gastroschisis, omphalocele).
- Infants diagnosed with immunodeficiency. -
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:NEC Study Group
Neonates diagnosed with Necrotizing enterocolitis during the neonatal period who are eveluated for allergens sensitization
|
Skin Prick Test Procedure: The SPT was performed when patients were free of acute health problems, and medications that could affect test results had been discontinued. A histamine solution (10 mg/mL, ALK-Abelló®, Canada) was used as a positive control, and 0.9% sodium chloride was used as a negative control. The test was performed on the volar surface of the forearm, and results were read after 20 minutes. A wheal ≥3 mm greater than the negative control, with erythema, was considered positive (Heinzerling L, et al. Clin Transl Allergy 2013;3:3). Sensitization to aeroallergens, including house dust mites (Dermatophagoides farinae, Dermatophagoides pteronyssinus), grass pollen mix, tree pollen mix, mold mix, cat epithelium, dog epithelium, and cockroach extract (ALK-Abelló®, Canada), was assessed. Sensitization to food allergens (cow's milk, egg, wheat, nuts, fish, and soy) was also evaluated using commercial extracts (ALK-Abelló®, Canada). |
|
实验性的:Control Group
Neonates without a history of Necrotizing enterocolitis who are eveluated for allergens sensitization
|
Skin Prick Test Procedure: The SPT was performed when patients were free of acute health problems, and medications that could affect test results had been discontinued. A histamine solution (10 mg/mL, ALK-Abelló®, Canada) was used as a positive control, and 0.9% sodium chloride was used as a negative control. The test was performed on the volar surface of the forearm, and results were read after 20 minutes. A wheal ≥3 mm greater than the negative control, with erythema, was considered positive (Heinzerling L, et al. Clin Transl Allergy 2013;3:3). Sensitization to aeroallergens, including house dust mites (Dermatophagoides farinae, Dermatophagoides pteronyssinus), grass pollen mix, tree pollen mix, mold mix, cat epithelium, dog epithelium, and cockroach extract (ALK-Abelló®, Canada), was assessed. Sensitization to food allergens (cow's milk, egg, wheat, nuts, fish, and soy) was also evaluated using commercial extracts (ALK-Abelló®, Canada). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The effect of necrotizing enterocolitis development in premature infants on response to allergens.
大体时间:Through study completion, an average of 1 year
|
The primary objective of this study was to compare the positivity rates on skin prick tests for airway allergens or food allergens in premature infants who developed NEC and those who did not, between the ages of 12 and 24 months.
|
Through study completion, an average of 1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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