Primary Allergy and Its Impact on the Occurrence of Respiratory Distress in Infants at 12 Months of Age
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 508
- Locations
- 1
- Primary Endpoint
- incidence of respiratory distress at 12 months of age in infants
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- — to 1 Year (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
newborns whose parents do not have allergies
Intervention: questionnaire (Other)
newborns who have at least one parent with allergies
Intervention: questionnaire (Other)
Outcomes
Primary Outcomes
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
- incidence of respiratory distress at 6 months of age in infants(at 6 months)
- incidence of respiratory distress when both parents are allergic(at 6 months)
- incidence of respiratory distress when both parents are allergic(at 12 months)
- incidence of respiratory distress requiring hospitalization when only one parent is allergic)(at 6 months)
- incidence of respiratory distress requiring hospitalization when only one parent is allergic)(at 12 months)
- incidence of respiratory distress when both parents are allergic, according to the type of allergy(at 6 months)
- incidence of respiratory distress when both parents are allergic, according to the type of allergy(at 12 months)
- incidence of respiratory distress requiring hospitalization when both parents are allergic(at 6 months)
- incidence of respiratory distress requiring hospitalization when both parents are allergic(at 12 months)
- incidence of atopic manifestations(at 12 months)
- correlation between changes in infant formula(at 6 months)
- correlation between changes in infant formula(at 12 months)
- correlation between variations in immediate postnatal parameters(at 6 months)