Investigation of Allergen Sensitization in Newborn Babies Diagnosed With 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.

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Key information

Conditions

Necrotizing Enterocolitis Allergy Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Hypersensitivity Immune System Diseases Intestinal Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Urogenital Diseases

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Skin prick test

Diagnostic 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).

Primary outcomes

The effect of necrotizing enterocolitis development in premature infants on response to allergens.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Allergy Risk and Sensitization Following Necrotizing Enterocolitis

Acronym: AlisNEC

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: May 1, 2026
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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