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

NCT07832643 | Recruiting

• 1 other identifier: PI2026_843_0085
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

Immediate Postnatal Parameters; Allergy; Respiratory Distress; Atopic Manifestations

Keywords

allergy; respiratory distress; atopic manifestations; immediate postnatal parameters

Outcome Measures

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

  at 12 months

Secondary Outcomes (13)

• 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

Study Arms (2)

newborns who have at least one parent with allergies

EXPERIMENTAL

Other: questionnaire

newborns whose parents do not have allergies

ACTIVE COMPARATOR

Other: questionnaire

Interventions

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.

newborns who have at least one parent with allergies; newborns whose parents do not have allergies

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Hypersensitivity; Dyspnea

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pierre TOURNEUX, Pr

CONTACT

33+3 22 08 76 04; tourneux.pierre@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)