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RecruitingNCT07832643AIREUpdated Sep 22, 2026

Primary Allergy and Its Impact on the Occurrence of Respiratory Distress in Infants at 12 Months of Age

An interventional study of questionnaire in Allergy, Respiratory Distress and Atopic Manifestations, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
508
Allocation
Non-randomized
Ages
Up to 1 Year
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Allergy
  • Respiratory Distress
  • Atopic Manifestations
  • Immediate Postnatal Parameters

Keywords

  • allergy
  • respiratory distress
  • atopic manifestations
  • immediate postnatal parameters
03

In context

Hypersensitivity

1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.

This study's planned enrollment of 508 is above the median of 73 across 691 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

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

04

Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
508 participants (estimated)

Study arms

  • Experimental
    newborns who have at least one parent with allergies

    Other: questionnaire

  • Active comparator
    newborns whose parents do not have allergies

    Other: questionnaire

Interventions

  • Otherquestionnaire

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at 12 months

Secondary outcomes

  1. 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

    Time frame: at 6 months

  2. 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)

    Time frame: at 6 months

  3. 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)

    Time frame: at 12 months

  4. 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)

    Time frame: at 6 months

  5. 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)

    Time frame: at 12 months

  6. 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)

    Time frame: at 6 months

  7. 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)

    Time frame: at 12 months

  8. 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)

    Time frame: at 6 months

  9. 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)

    Time frame: at 12 months

  10. 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)

    Time frame: at 12 months

  11. 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

    Time frame: at 6 months

  12. 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

    Time frame: at 12 months

  13. 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.

    Time frame: at 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832643
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Jul 1, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 22, 2026

Study contacts

Pierre TOURNEUX, Pr
Contact
tourneux.pierre@chu-amiens.fr
33+3 22 08 76 04

Oversight

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

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