Associations between newborn thyroid-stimulating hormone concentration and neurodevelopment and growth of children at 18 months.

The study aimed to assess the associations between newborn thyroid-stimulating hormone (TSH) concentration, a marker of iodine nutrition in early life, and childhood neurodevelopment and growth using data collected from two pregnancy studies, one in a borderline iodine-deficient setting (DHA to Optimize Mother Infant Outcome (DOMInO) Study) and one in an iodine-sufficient setting (Pregnancy Iodine and Neurodevelopment in Kids (PINK) Study). TSH data were obtained from routine newborn screening. Neurodevelopment was assessed at 18 months using the Bayley Scales of Infant and Toddler Development, third edition (Bayley-III). Weight, height and head circumference were measured at 18 months. In total, 1467 children were included in the analysis. Comparing the highest with the lowest TSH quartile, the mean differences (MD) in the Bayley-III scores ranged from -2·0 (95 % CI -4·7, 0·7) to -2·2 (95 % CI -5·8, 1·3) points in DOMInO and 1·0 (95 % CI -1·6, 3·6) to 2·0 (95 % CI -0·4, 4·4) points in PINK in the cognitive, language and motor scales; the MD in the anthropometric z scores ranged from -0·01 (95 % CI -0·5, 0·5) to -0·5 (95 % CI -0·9, -0·1) in both studies. A 1 mIU/l increase in TSH was associated with -0·3 (95 % CI -0·9, 0·2) point and 0·2 (95 % CI -0·3, 0·7) point changes in the mean cognitive score in the DOMInO and PINK, respectively. A null association between TSH and growth was also observed in both studies. Longitudinal studies that utilise newborn TSH data and examine neurodevelopmental outcomes at later ages are warranted, as neurodevelopmental assessments in older children are more predictive of later achievement.

Accounting for multiple births in randomised trials: a systematic review.

OBJECTIVES: Multiple births are an important subgroup to consider in trials aimed at reducing preterm birth or its consequences. Including multiples results in a unique mixture of independent and clustered data, which has implications for the design, analysis and reporting of the trial. We aimed to determine how multiple births were taken into account in the design and analysis of recent trials involving preterm infants, and whether key information relevant to multiple births was reported. DESIGN: We conducted a systematic review of multicentre randomised trials involving preterm infants published between 2008 and 2013. Information relevant to multiple births was extracted. RESULTS: Of the 56 trials included in the review, 6 (11%) excluded multiples and 24 (43%) failed to indicate whether multiples were included. Among the 26 trials that reported multiples were included, only one (4%) accounted for clustering in the sample size calculations and eight (31%) took the clustering into account in the analysis of the primary outcome. Of the 20 trials that randomised infants, 12 (60%) failed to report how infants from the same birth were randomised. CONCLUSIONS: Information on multiple births is often poorly reported in trials involving preterm infants, and clustering due to multiple births is rarely taken into account. Since ignoring clustering could result in inappropriate recommendations for clinical practice, clustering should be taken into account in the design and analysis of future neonatal and perinatal trials including infants from a multiple birth.