ESPE2015 Free Communications Thyroid (6 abstracts)
Effects of Initial Levothyroxine Dose on Growth and Neurodevelopmental Outcomes During the First Year of Life in Children with Congenital Hypothyroidism
Andrea Esposito a , Gianluca D’Onofrio a , Alessandra Cassio b , Andrea Corrias c , Roberto Gastaldi d , Maria Cristina Vigone e , Malgorzata Gabriela Wasniewska f , Giovanna Weber e & Mariacarolina Salerno a
aPediatric Endocrinology Unit, Department of Transaltional Medical Sciences, University of Naples Federico II, Naples, Italy; bPediatric Department, Sant’Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; cDivision of Pediatric Endocrinology, Department of Pediatrics and Public Health, Regina Margherita Children’s Hospital, University of Turin, Turin, Italy; dDepartment of Pediatrics, Istituto Giannina Gaslini, Genoa, Italy; eDepartment of Pediatrics, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Milan, Italy; fDepartment of Pediatrics, University of Messina, Messina, Italy
Background: An important issue in the management of congenital hypothyroidism (CH) is the best initial dose of levothyroxine (L-T4) in order to achieve optimal neurocognitive outcomes. Both European and American guidelines suggest an initial dose of 10–15 μg/kg per die but trials on long-term effects of different doses within this range are lacking.
Objective and hypotheses: This was a multicenter randomized trial to evaluate the effects of the initial dose of L-T4 on growth and neurodevelopmental outcomes in children with CH.
Method: Seventy-two children with CH diagnosed by neonatal screening were enrolled in the study. They were randomly assigned to receive an initial L-T4 dose of 10–12.5 μg/kg per die (group A) or 12.6–15 μg/kg per die (group B). All patients underwent clinical examination and FT4 and TSH measurement after 7–10 days of treatment and at the age of 1.5, 3, 6, 9 and 12 months. At the age of 12 months they underwent Griffiths Mental Development Scales to evaluate cognitive development. Four patients were lost to the follow-up and two patients have not yet reached 12 months of age; therefore only 66 children (32 from group A and 34 from group B) concluded the first year of study.
Results: No significant differences were detected in auxological parameters between the two groups (Table 1).
The intelligent quotient (IQ) at 12 months of age was similar in the two groups (104.79±13.18 vs 104.77±12.81). IQ correlated with age at diagnosis (r=−0.03, P=0.02) and FT4 levels after 7–10 days of L-T4 therapy (r=0.33, P=0.01).
| 3 months | 6 months | 9 months | 12 months | |
| Weight SDS | ||||
| Group A | 0.50±1.25 | 0.28±1.36 | 0.13±1.37 | 0.16±1.29 |
| Group B | 0.66±0.87 | 0.66±0.98 | 0.55±1.17 | 0.38±1.09 |
| Length SDS | ||||
| Group A | 0.32±1.07 | 0.31±1.01 | 0.22±1.08 | 0.08±1.03 |
| Group B | 0.34±1.11 | 0.47±1.16 | 0.30±1.23 | 0.20±1.17 |
Conclusion: Different initial doses of L-T4 within the range of 10–15 μg/kg per die provide similar outcomes in growth and neurocognitive development in CH patients.
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