Primary Allergy and Its Impact on the Occurrence of Respiratory Distress in Infants at 12 Months of Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 1
- 主要终点
- incidence of respiratory distress at 12 months of age in infants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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)
研究组 & 干预措施
newborns whose parents do not have allergies
干预措施: questionnaire (Other)
newborns who have at least one parent with allergies
干预措施: questionnaire (Other)
结局指标
主要结局
incidence of respiratory distress at 12 months of age in infants
时间窗: 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
次要结局
- 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)