Height (or length) and weight |
Study staff measure the mother’s height and weight at enrollment and at the 2- and 12-month clinic visits; the father’s at enrollment; and the child’s at each clinic visit. If the father does not come for a clinic visit, the information may be collected by questionnaire. |
Allergen SPT |
In children only, study staff conduct allergy SPT to food allergens at the 5-, 12-, 24-, and 36-month visits and to aeroallergens at the 12-, 24-, and 36-month visits.∗
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OFC |
Starting at age 5 months, allergy to protocol-specified foods is assessed at each clinic visit. Open, graded OFCs are conducted when indicated by the FA algorithm.† Some combinations of food exposure history, symptomology, and SPT wheal size or specific IgE concentration require an OFC to determine allergy status, whereas other combinations do not. Large clinic visit windows are provided to accommodate multiple OFCs for a given child. If an OFC is indicated, before the first OFC, the mother or legal guardian will provide written informed consent. |
SCORAD and EASI |
Study staff conducts a visual assessment of the child’s skin at every clinic visit. AD is scored by SCORAD and EASI at each clinic visit. |
TEWL |
Study staff measure TEWL on the mother’s skin at enrollment and at the child’s 2-month visit; on the father’s skin at enrollment; and on the child’s skin at 1-2 days after birth (or during the first 7 days at a home visit, an unscheduled study visit, or a pediatrician visit if not collected before hospital discharge) and at every clinic visit. TEWL is measured with a GPSkin Pro device. |
Addendum guidelines counseling |
Study staff counsel parents at the 2-month visit on the Addendum Guidelines for the Prevention of Peanut Allergy35 and offer the option of the child receiving a guidelines-based assessment and recommendation at any time between ages 4 and 6 months. The ±1-month window for the 5-month visit provides for a guidelines-based assessment between ages 4 and 6 months. |