Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year

Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year - Sensitization to Allergic Food with Eczema and Timing of food introduction in a Year (SAFETY study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000026369

Enrollment

1000

Registered

2017-03-09

Start date

2017-03-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy infants

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Infants fulfilling all of the following criteria: 1) Whose gestational age was 37 weeks or older. 2) Whose birth weight was 2300g or more. 3) Who are under 2 months of age at time of recruitment.

Exclusion criteria

Exclusion criteria: Infants fulfilling or suspected to fulfill any of the following criteria: 1) With immune deficiency. 2) With a severe congenital disorder. 3) With a disorder which affects the introduction timing of complementary feeding, like a neuromuscular disease. 4) With skin abnormality which affects determination of infantile eczema.

Design outcomes

Primary

Measure	Time frame
Positive rate of specific IgE to egg white at the age of 12 and 36 months	—

Secondary

Measure	Time frame
At the age of 12 months: -positive rate of specific IgE to ovomucoid, cow's milk and casein -value of specific IgE to egg white, ovomucoid, cow's milk and casein -value of specific IgG4 to egg white, ovomucoid and casein -value of non-specific IgE -prevalence rate of eczema with medical determination In 12 months of life: -incidence rate of immediate food allergy reaction At the age of 36 months: -positive rate of specific IgE to ovomucoid, cow's milk, casein, Japanese cedar and mite -value of specific IgE to egg white, ovomucoid, cow's milk, casein, Japanese cedar and mite -value of specific IgG4 to egg white, ovomucoid and casein -value of non-specific IgE -prevalence rate of asthma, allergic rhino-conjunctivitis and atopic dermatitis In 36 months of life: -incidence rate of immediate food allergy reaction	—

Measure

Time frame

At the age of 12 months: -positive rate of specific IgE to ovomucoid, cow's milk and casein -value of specific IgE to egg white, ovomucoid, cow's milk and casein -value of specific IgG4 to egg white, ovomucoid and casein -value of non-specific IgE -prevalence rate of eczema with medical determination In 12 months of life: -incidence rate of immediate food allergy reaction At the age of 36 months: -positive rate of specific IgE to ovomucoid, cow's milk, casein, Japanese cedar and mite -value of specific IgE to egg white, ovomucoid, cow's milk, casein, Japanese cedar and mite -value of specific IgG4 to egg white, ovomucoid and casein -value of non-specific IgE -prevalence rate of asthma, allergic rhino-conjunctivitis and atopic dermatitis In 36 months of life: -incidence rate of immediate food allergy reaction

—

Countries

Japan

Contacts

Public ContactMasaki Futamura

National Hospital Organization Nagoya Medical Center Division of Pediatrics

safety.nho@gmail.com052-951-1111

Outcome results