Protocol of the PSYCHOTSH study: association between neonatal thyroid stimulating hormone concentration and intellectual, psychomotor and psychosocial development at 4–5 year of age: a retrospective cohort study

BACKGROUND: Several European countries, including Belgium, still suffer from mild iodine deficiency. Thyroid stimulating hormone (TSH) concentration in whole blood measured at birth has been proposed as an indicator of maternal iodine status during the last trimester of pregnancy. It has been shown that mild iodine deficiency during pregnancy may affect the neurodevelopment of the offspring. In several studies, elevated TSH levels at birth were associated with suboptimal cognitive and psychomotor outcomes among young children. This paper describes the protocol of the PSYCHOTSH study aiming to assess the association between neonatal TSH levels and intellectual, psychomotor and psychosocial development of 4–5 year old children. The results could lead to a reassessment of the recommended cut-off levels of 5 > mU/L used for monitoring iodine status of the population. METHODS: In total, 380 Belgian 4–5 year old preschool children from Brussels and Wallonia with a neonatal blood spot TSH concentration between 0 and 15 mU/L are included in the study. For each sex and TSH-interval (0–1, 1–2, 2–3, 3–4, 4–5, 5–6, 6–7, 7–8, 8–9 and 9–15 mU/L), 19 newborns were randomly selected from all newborns screened by the neonatal screening centre in Brussels in 2008–2009. Infants with congenital hypothyroidism, low birth weight and prematurity were excluded from the study. Neonatal TSH concentration was measured by the Autodelphia method in dried blood spots, collected by heel stick on filter paper 3 to 5 days after birth. Cognitive abilities and psychomotor development are assessed using the Wechsler Preschool and Primary Scale of Intelligence - third edition - and the Charlop-Atwell Scale of Motor coordination. Psychosocial development is measured using the Child Behaviour Check List for age 1½ to 5 years old. In addition, several socioeconomic, parental and child confounding factors are assessed. CONCLUSIONS: This study aims to clarify the effect of mild iodine deficiency during pregnancy on the neurodevelopment of the offspring. Therefore, the results may have important implications for future public health recommendations, policies and practices in food supplementation. In addition, the results may have implications for the use of neonatal TSH screening results for monitoring the population iodine status and may lead to the definition of new TSH cut-offs for determination of the severity of iodine status and for practical use in data reporting by neonatal screening centres.