Necrotizing EnterocolitisAlisNECNCT07562009
Investigation of Allergen Sensitization in Newborn Babies Diagnosed With Necrotizing Enterocolitis.
A study testing skin prick test in people with Necrotizing Enterocolitis and Allergy, run by Saglik Bilimleri Universitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis, Allergy, Preterm
- What is being tested?
- skin prick test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- -
Who cannot join
- 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. -
About this study
Official title: Allergy Risk and Sensitization Following 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.
- Conditions
- Necrotizing Enterocolitis, Allergy, Preterm
- Being tested
- skin prick test
- Medical subject headings
- Enterocolitis, Necrotizing, Hypersensitivity, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin prick testDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| NEC Study Group | Experimental | Neonates diagnosed with Necrotizing enterocolitis during the neonatal period who are eveluated for allergens sensitization Receives: Diagnostic Test: skin prick test |
| Control Group | Experimental | Neonates without a history of Necrotizing enterocolitis who are eveluated for allergens sensitization Receives: Diagnostic Test: skin prick test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562009
- Sponsor's protocol ID
- 2026-01
- Acronym
- AlisNEC
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy Risk and Sensitization Following Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT07562009
- Acronym / sponsor ID
- AlisNEC / 2026-01
- Conditions
- Necrotizing Enterocolitis, Allergy, Preterm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NEC Study Group | Experimental | Diagnostic Test: skin prick testNeonates diagnosed with Necrotizing enterocolitis during the neonatal period who are eveluated for allergens sensitization |
| Control Group | Experimental | Diagnostic Test: skin prick testNeonates without a history of Necrotizing enterocolitis who are eveluated for allergens sensitization |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
- -
Key exclusion criteria (5 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin prick 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). | Diagnostic test | Control Group, NEC Study Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Related trials for Necrotizing Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing skin prick test in people with Necrotizing Enterocolitis and Allergy, run by Saglik Bilimleri Universitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of necrotizing enterocolitis development in premature infants on response to allergens. (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.