Supplemental Iodide for Preterm Infants and Developmental Outcomes at 2 Years: An RCT
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Supplemental Iodide for Preterm Infants and Developmental Outcomes at 2 Years : An RCT. / Williams, Fiona L R; Ogston, Simon; Hume, Robert; Watson, Jennifer; Stanbury, Kayleigh; Willatts, Peter; Boelen, Anita; Juszczak, Edmund; Brocklehurst, Peter; I2S2 team.
In: Pediatrics, Vol. 139, No. 5, e20163703, 05.2017.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Supplemental Iodide for Preterm Infants and Developmental Outcomes at 2 Years
T2 - An RCT
AU - Williams, Fiona L R
AU - Ogston, Simon
AU - Hume, Robert
AU - Watson, Jennifer
AU - Stanbury, Kayleigh
AU - Willatts, Peter
AU - Boelen, Anita
AU - Juszczak, Edmund
AU - Brocklehurst, Peter
AU - I2S2 team
N1 - Copyright © 2017 by the American Academy of Pediatrics.
PY - 2017/5
Y1 - 2017/5
N2 - BACKGROUND: The recommendation for enteral iodide intake for preterm infants is 30 to 40 μg/kg per day and 1 μg/kg per day for parenteral intake. Preterm infants are vulnerable to iodide insufficiency and thyroid dysfunction. The hypothesis tested whether, compared with placebo, iodide supplementation of preterm infants improves neurodevelopment.METHODS: A randomized controlled trial of iodide supplementation versus placebo in infants <31 weeks' gestation. Trial solutions (sodium iodide or sodium chloride; dose 30 μg/kg per day) were given within 42 hours of birth to the equivalent of 34 weeks' gestation. The only exclusion criterion was maternal iodide exposure during pregnancy or delivery. Whole blood levels of thyroxine, thyrotropin, and thyroid-binding globulin were measured on 4 specific postnatal days. The primary outcome was neurodevelopmental status at 2 years of age, measured by using the Bayley Scales of Infant Development-III. The primary analyses are by intention-to-treat, and data are presented also for survivors.RESULTS: One thousand two hundred seventy-three infants (637 intervention, 636 placebo) were recruited from 21 UK neonatal units. One hundred thirty-one infants died, and neurodevelopmental assessments were undertaken in 498 iodide and 499 placebo-supplemented infants. There were no significant differences between the intervention and placebo groups in the primary outcome: mean difference cognitive score, -0.34, 95% confidence interval (CI) -2.57 to 1.89; motor composite score, 0.21, 95% CI -2.23 to 2.65; and language composite score, -0.05, 95% CI -2.48 to 2.39. There was evidence of weak interaction between iodide supplementation and hypothyroxinemic status in the language composite score and 1 subtest score.CONCLUSIONS: Overall iodide supplementation provided no benefit to neurodevelopment measured at 2 years of age.
AB - BACKGROUND: The recommendation for enteral iodide intake for preterm infants is 30 to 40 μg/kg per day and 1 μg/kg per day for parenteral intake. Preterm infants are vulnerable to iodide insufficiency and thyroid dysfunction. The hypothesis tested whether, compared with placebo, iodide supplementation of preterm infants improves neurodevelopment.METHODS: A randomized controlled trial of iodide supplementation versus placebo in infants <31 weeks' gestation. Trial solutions (sodium iodide or sodium chloride; dose 30 μg/kg per day) were given within 42 hours of birth to the equivalent of 34 weeks' gestation. The only exclusion criterion was maternal iodide exposure during pregnancy or delivery. Whole blood levels of thyroxine, thyrotropin, and thyroid-binding globulin were measured on 4 specific postnatal days. The primary outcome was neurodevelopmental status at 2 years of age, measured by using the Bayley Scales of Infant Development-III. The primary analyses are by intention-to-treat, and data are presented also for survivors.RESULTS: One thousand two hundred seventy-three infants (637 intervention, 636 placebo) were recruited from 21 UK neonatal units. One hundred thirty-one infants died, and neurodevelopmental assessments were undertaken in 498 iodide and 499 placebo-supplemented infants. There were no significant differences between the intervention and placebo groups in the primary outcome: mean difference cognitive score, -0.34, 95% confidence interval (CI) -2.57 to 1.89; motor composite score, 0.21, 95% CI -2.23 to 2.65; and language composite score, -0.05, 95% CI -2.48 to 2.39. There was evidence of weak interaction between iodide supplementation and hypothyroxinemic status in the language composite score and 1 subtest score.CONCLUSIONS: Overall iodide supplementation provided no benefit to neurodevelopment measured at 2 years of age.
KW - Brain
KW - Child Development
KW - Child, Preschool
KW - Follow-Up Studies
KW - Humans
KW - Infant
KW - Infant, Premature
KW - Iodides
KW - Parenteral Nutrition
KW - Thyrotropin
KW - Thyroxine
KW - Thyroxine-Binding Globulin
KW - Treatment Outcome
KW - Journal Article
KW - Pragmatic Clinical Trial
U2 - 10.1542/peds.2016-3703
DO - 10.1542/peds.2016-3703
M3 - Article
C2 - 28557747
VL - 139
JO - Pediatrics
JF - Pediatrics
SN - 0031-4005
IS - 5
M1 - e20163703
ER -