Medical Office
Taverny, France
NCT Number: NCT04182425
This study will evaluate the incidence of allergic manifestations (the first of which is atopic dermatitis) and infectious diseases in children fed with an infant formula under real conditions of use.
Looking for future studies?
Notify MeUp to 5 week
All sexes
Observational
Taverny, France
The primary objective of the study is to evaluate the cumulative incidence of atopic dermatitis in healthy infants at risk for dysbiosis at 12 months of age and to identify factors associated with the presence of atopic dermatitis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Healthy full-term infants fed on an infant formula marketed on the French market
Time frame: 12 months
Number of episodes of dermatitis reported during the 12 months of follow-up, and objectified by a SCORAD score > 0.
Time frame: 3, 6 and 12 months
Cumulative incidence of episodes of moderate atopic dermatitis (SCORAD score of 25 to 50) or severe episodes (SCORAD score> 50)
Time frame: 3, 6 and 12 months
Time frame: 3, 6 and 12 months
Growth in term of height
Time frame: 3, 6 and 12 months
Growth in term of weight
Time frame: 3, 6 and 12 months
Growth in terme of cranial perimeter
Time frame: 3, 6 and 12 months
% of children who consumed the formula prescribed by the doctor at the previous visit
Time frame: 3, 6 and 12 months
Number of days of consumption during the previous period.
Time frame: 3, 6 and 12 months
5-level Likert scale filled in by the doctor and by parents
Time frame: 3, 6 and 12 months
Cumulative number since the inclusion of episodes of:
Time frame: 3, 6 and 12 months
Cumulative number since the inclusion of episodes of:
Bledina
Industry
Real-life Study to Assess the Incidence of Allergic Manifestations and Infectious Episodes in Healthy Term Infants at Risk of Dysbiosis During the First Year of Life
Acronym: SOPRANO
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.
Published trials that share one or more normalized conditions with this study.
NCT00928447
Dermatitis, Dermatitis, Allergic Contact
Michigan City, Indiana, United States
View Trial DetailsNCT03522675
Allergy, Allergy Skin
Buffalo, New York, United States
View Trial DetailsNCT01953380
Dermatitis, Dermatitis, Allergic Contact
Lund, Skåne County, Sweden
View Trial DetailsNCT00141180
Dermatitis, Dermatitis, Allergic Contact
Ann Arbor, Michigan, United States
View Trial Details