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

Allergy Risk and Sensitization Following Necrotizing Enterocolitis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07562009
Acronym
AlisNEC
Enrollment
130
Registered
2026-05-01
Start date
2026-04-01
Completion date
2028-01-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Necrotizing Enterocolitis, Preterm

Brief summary

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.

Interventions

DIAGNOSTIC_TESTskin prick test

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).

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Premature babies with NEC Stages I, II, and III will be evaluated between 12 and 24 months of life and will undergo a skin prick test. As a control, preterm babies who have not experienced NEC will be evaluated between 12 and 24 months and will undergo a skin prick test.

Eligibility

Sex/Gender
ALL
Age
12 Months to 24 Months
Healthy volunteers
Yes

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. -

Design outcomes

Primary

MeasureTime frameDescription
The effect of necrotizing enterocolitis development in premature infants on response to allergens.Through study completion, an average of 1 yearThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026