Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorSaglik Bilimleri Universitesi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
skin prick test
Diagnostic testSkin 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).
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: NEC Study GroupExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The effect of necrotizing enterocolitis development in premature infants on response to allergens.
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.
Time frame
Through study completion, an average of 1 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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