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NCT Number: NCT07832643

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

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.

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Key information

Conditions

Allergy Atopic Manifestations Dyspnea Hypersensitivity Immediate Postnatal Parameters Immune System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Pierre TOURNEUX, PhD

CONTACT

[email protected]

+33322668652

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. incidence of respiratory distress at 6 months of age in infants

    Time frame: at 6 months

    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

  2. incidence of respiratory distress when both parents are allergic

    Time frame: at 6 months

    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)

  3. incidence of respiratory distress when both parents are allergic

    Time frame: at 12 months

    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)

  4. 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, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)

  5. incidence of respiratory distress requiring hospitalization when only one parent is allergic)

    Time frame: at 12 months

    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)

  6. 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 (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)

  7. incidence of respiratory distress when both parents are allergic, according to the type of allergy

    Time frame: at 12 months

    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)

  8. 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, according to the type of allergy (respiratory, food, drug-related, or other) compared to a control group (no allergy for both parents)

  9. incidence of respiratory distress requiring hospitalization when both parents are allergic

    Time frame: at 12 months

    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)

  10. incidence of atopic manifestations

    Time frame: at 12 months

    incidence of atopic manifestations, depending on the presence or absence of parental allergies compared to a control group (no allergy for both parents)

  11. correlation between changes in infant formula

    Time frame: at 6 months

    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

  12. correlation between changes in infant formula

    Time frame: at 12 months

    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

  13. correlation between variations in immediate postnatal parameters

    Time frame: at 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre TOURNEUX, Pr

CONTACT

[email protected]

33+3 22 08 76 04

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: AIRE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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