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Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis. (AlisNEC)

2026年4月24日 更新者:Saglik Bilimleri Universitesi

Allergy Risk and Sensitization Following Necrotizing Enterocolitis

To evaluate the frequency of allergy between 12 and 24 months of age in infants who were treated in the neonatal clinic and had NEC. To investigate the relationship between NEC development and the development of allergy in the later period.

研究概览

研究类型

介入性

注册 (估计的)

130

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Infants born in our hospital and diagnosed with NEC during the study period.
  2. Age-matched control infants born in our hospital during the same period but without NEC diagnosis.
  3. Written and verbal informed consent obtained from at least one parent.

    -

Exclusion Criteria:

  1. Infants whose parents did not provide written or verbal consent.
  2. Infants with major congenital anomalies.
  3. Infants with chromosomal disorders.
  4. Infants with gastrointestinal malformations (e.g., duodenal atresia, gastroschisis, omphalocele).
  5. Infants diagnosed with immunodeficiency. -

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年4月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2026年3月5日

首先提交符合 QC 标准的

2026年4月24日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年5月1日

上次提交的符合 QC 标准的更新

2026年4月24日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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