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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • questionnaire

    Other intervention

    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.

Treatment groups

508 Participants
are divided into 2 treatment groups
Group A: newborns who have at least one parent with allergiesExperimental treatment 1 intervention
Group B: newborns whose parents do not have allergiesActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.