AllergyAIRENCT07832643
Primary Allergy and Its Impact on the Occurrence of Respiratory Distress in Infants at 12 Months of Age
A study testing questionnaire in people with Allergy and Respiratory Distress, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The number of people with allergies has been steadily increasing over the years. Symptoms in infants, such as bronchiolitis, gastroesophageal reflux, eczema, or atopic dermatitis, can be early warning signs of allergies in childhood. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Allergy, Respiratory Distress, Atopic Manifestations
- What is being tested?
- questionnaire
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2026to Jul 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns delivered at Amiens Picardie University Hospital, Full-term newborns, i.e.,
- ≥ 37+0 weeks of gestation (SA),
- Newborns whose mothers are of legal age and capable of understanding, reading, and speaking French or, failing that, who have someone in their immediate circle capable of understanding, reading, and speaking French;
- Newborns whose mothers are enrolled in the social security system;
Who cannot join
- Premature newborns
- Newborns whose parents refused to allow them to participate in the study
- Newborns from multiple pregnancies
- Newborns with malformations diagnosed prenatally or immediately after birth (in the delivery room)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Pierre TOURNEUX, PhD, +33322668652, tourneux.pierre@chu-amiens.fr
About this study
The number of people with allergies has been steadily increasing over the years. Symptoms in infants, such as bronchiolitis, gastroesophageal reflux, eczema, or atopic dermatitis, can be early warning signs of allergies in childhood. Given the rising prevalence of allergies and the number of children affected by bronchiolitis, it is worth investigating whether the presence of allergies in parents is associated with a higher likelihood of developing bronchiolitis in childhood.
To determine the incidence of respiratory distress in infants with at least one allergic parent compared to infants with no allergic parents at 12 months of age.
Read more
Parents will be asked to complete a questionnaire at two time points: at 6 months and at 12 months of age.
The incidence of bronchiolitis during the first year of life is higher among infants with at least one parent who has allergies.
- Being tested
- questionnaire
- Keywords
- allergy, respiratory distress, atopic manifestations, immediate postnatal parameters
- Medical subject headings
- Hypersensitivity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire will be emailed when the child is 6 months old and again when the child is 12 months old. These questionnaires include questions about any health issues that have arisen since the last contact, the number and reason for the child's hospitalizations (if applicable), the child's vaccinations, and the child's diet.
| Study group | Role | What they receive |
|---|---|---|
| newborns who have at least one parent with allergies | Experimental | Not described Receives: Other: questionnaire |
| newborns whose parents do not have allergies | Active comparator | Not described Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of respiratory distress at 12 months of age in infants
incidence of respiratory distress at 12 months of age in infants with at least one allergic parent, compared with those whose parents have no history of allergy, at 12 months
Measured: at 12 months
Secondary outcomes (13)
incidence of respiratory distress at 6 months of age in infants
incidence of respiratory distress at 6 months of age in infants with at least one allergic parent, compared with those whose parents have no history of allergy
Measured: at 6 months
incidence of respiratory distress when both parents are allergic
determine the incidence of respiratory distress when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 6 months
incidence of respiratory distress when both parents are allergic
determine the incidence of respiratory distress when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 12 months
incidence of respiratory distress requiring hospitalization when only one parent is allergic)
incidence of respiratory distress requiring hospitalization when only one parent is allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 6 months
incidence of respiratory distress requiring hospitalization when only one parent is allergic)
incidence of respiratory distress requiring hospitalization when only one parent is allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 12 months
incidence of respiratory distress when both parents are allergic, according to the type of allergy
incidence of respiratory distress when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 6 months
incidence of respiratory distress when both parents are allergic, according to the type of allergy
incidence of respiratory distress when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 12 months
incidence of respiratory distress requiring hospitalization when both parents are allergic
incidence of respiratory distress requiring hospitalization when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 6 months
incidence of respiratory distress requiring hospitalization when both parents are allergic
incidence of respiratory distress requiring hospitalization when both parents are allergic, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)
Measured: at 12 months
incidence of atopic manifestations
incidence of atopic manifestations, depending on the presence or absence of parental allergies compared to a control group (no allergy for both parents)
Measured: at 12 months
correlation between changes in infant formula
correlation between changes in infant formula (e.g., thickened formulas or specialized formulas such as Allernova) in cases of suspected cow's milk protein allergy or gastroesophageal reflux, and the presence of parental allergies
Measured: at 6 months
correlation between changes in infant formula
correlation between changes in infant formula (e.g., thickened formulas or specialized formulas such as Allernova) in cases of suspected cow's milk protein allergy or gastroesophageal reflux, and the presence of parental allergies
Measured: at 12 months
correlation between variations in immediate postnatal parameters
correlation between variations in immediate postnatal parameters (Apgar score, jaundice, immediate respiratory distress, neonatal infection, birth weight loss, etc.) and the allergic status of at least one parent.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832643
- Sponsor's protocol ID
- PI2026_843_0085
- Acronym
- AIRE
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Allergy and Its Impact on the Occurrence of Respiratory Distress in Infants at 12 Months of Age
- ClinicalTrials.gov ID
- NCT07832643
- Acronym / sponsor ID
- AIRE / PI2026_843_0085
- Keywords
- allergy, respiratory distress, atopic manifestations, immediate postnatal parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Sep 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.
The number of people with allergies has been steadily increasing over the years. Symptoms in infants, such as bronchiolitis, gastroesophageal reflux, eczema, or atopic dermatitis, can be early warning signs of allergies in childhood. Given the rising prevalence of allergies and the number of children affected by bronchiolitis, it is worth investigating whether the presence of allergies in parents is associated with a higher likelihood of developing bronchiolitis in childhood.
To determine the incidence of respiratory distress in infants with at least one allergic parent compared to infants with no allergic parents at 12 months of age.
Parents will be asked to complete a questionnaire at two time points: at 6 months and at 12 months of age.
The incidence of bronchiolitis during the first year of life is higher among infants with at least one parent who has allergies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| newborns who have at least one parent with allergies | Experimental | Other: questionnaire |
| newborns whose parents do not have allergies | Active comparator | Other: questionnaire |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newborns delivered at Amiens Picardie University Hospital, Full-term newborns, i.e.,
- ≥ 37+0 weeks of gestation (SA),
- Newborns whose mothers are of legal age and capable of understanding, reading, and speaking French or, failing that, who have someone in their immediate circle capable of understanding, reading, and speaking French;
- Newborns whose mothers are enrolled in the social security system;
Key exclusion criteria (4 listed)
- Premature newborns
- Newborns whose parents refused to allow them to participate in the study
- Newborns from multiple pregnancies
- Newborns with malformations diagnosed prenatally or immediately after birth (in the delivery room)
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 |
|---|---|---|
| questionnairequestionnaire will be emailed when the child is 6 months old and again when the child is 12 months old. These questionnaires include questions about any health issues that have arisen since the last contact, the number and reason for the child's hospitalizations (if applicable), the child's vaccinations, and the child's diet. | Other | newborns who have at least one parent with allergies, newborns whose parents do not have allergies |
Primary outcome
incidence of respiratory distress at 12 months of age in infants
Time frame: at 12 months
incidence of respiratory distress at 12 months of age in infants with at least one allergic parent, compared with those whose parents have no history of allergy, at 12 months
13 secondary outcomes
incidence of respiratory distress at 6 months of age in infants
Time frame: at 6 months
incidence of respiratory distress when both parents are allergic
Time frame: at 6 months
incidence of respiratory distress when both parents are allergic
Time frame: at 12 months
incidence of respiratory distress requiring hospitalization when only one parent is allergic)
Time frame: at 6 months
incidence of respiratory distress requiring hospitalization when only one parent is allergic)
Time frame: at 12 months
incidence of respiratory distress when both parents are allergic, according to the type of allergy
Time frame: at 6 months
incidence of respiratory distress when both parents are allergic, according to the type of allergy
Time frame: at 12 months
incidence of respiratory distress requiring hospitalization when both parents are allergic
Time frame: at 6 months
incidence of respiratory distress requiring hospitalization when both parents are allergic
Time frame: at 12 months
incidence of atopic manifestations
Time frame: at 12 months
correlation between changes in infant formula
Time frame: at 6 months
correlation between changes in infant formula
Time frame: at 12 months
correlation between variations in immediate postnatal parameters
Time frame: at 6 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 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire in people with Allergy and Respiratory Distress, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 4 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Pierre TOURNEUX, Pr (33+3 22 08 76 04, tourneux.pierre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of respiratory distress at 12 months of age in infants (time frame: at 12 months). 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 22 Sep 2026.