ClinicalTrials.gg
Not yet recruitingNCT07562009AlisNECUpdated May 1, 2026

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

An interventional study of skin prick test in Necrotizing Enterocolitis, Allergy and Preterm, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting. Open to participants aged 12 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
12 Months to 24 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Necrotizing Enterocolitis
  • Allergy
  • Preterm
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 130 is above the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 obtained from at least one parent.

    -

Exclusion criteria

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. -
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    NEC Study Group

    Neonates diagnosed with Necrotizing enterocolitis during the neonatal period who are eveluated for allergens sensitization

    Diagnostic Test: skin prick test

  • Experimental
    Control Group

    Neonates without a history of Necrotizing enterocolitis who are eveluated for allergens sensitization

    Diagnostic Test: skin prick test

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).

06

What researchers measure

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 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07562009
Responsible party
Sponsor
First posted
May 1, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Oct 1, 2027 (estimated)
Completion
Jan 1, 2028 (estimated)
Last update
May 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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