Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis. (AlisNEC)
Allergy Risk and Sensitization Following Necrotizing Enterocolitis
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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. -
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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). |
|
Experimental: 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The effect of necrotizing enterocolitis development in premature infants on response to allergens.
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades intestinales
- Enfermedades del sistema inmunológico
- Trabajo de parto prematuro, obstétrico
- Complicaciones obstétricas del parto
- Complicaciones del embarazo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Gastroenteritis
- Enterocolitis
- Nacimiento prematuro
- Hipersensibilidad
- Enterocolitis Necrotizante
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas inmunológicas
- Pruebas inmunológicas
- Pruebas de piel
- Pruebas de parche
Otros números de identificación del estudio
- 2026-01 (Hitit University Non-Interventional Research Ethics Committee)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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