Phase 1 trial of 4 thyroid hormone regimens for transient hypothyroxinemia in neonates of <28 weeks' gestation

Pediatrics

Volumn 124, Issue 2, 2009, Pages

  La Gamma, Edmund F ^a   Van Wassenaer, Aleid G ^b   Ares, Susana ^c   Golombek, Sergio G ^a   Kok, Joke H ^b   Quero, Jose ^c   Hong, Ting ^d,e   Rahbar, Mohammad H ^e   Morreale De Escobar, Gabriella ^f   Fisher, Delbert A ^g   Paneth, Nigel ^d,e  

^a WESTCHESTER MEDICAL CENTER   (United States)

^b EMMA CHILDREN S HOSPITAL   (Netherlands)

^c HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^d INSTITUTO DE INVESTIGACIONES BIOMÉDICAS ALBERTO SOLS   (Spain)

^e MICHIGAN STATE UNIVERSITY   (United States)

^f UNIVERSITY OF TEXAS   (United States)

^g QUEST DIAGNOSTICS NICHOLS INSTITUTE   (United States)

Author keywords

Cerebral palsy; Controlled trial; Euthyroid sick syndrome; Extremely low birth weight neonate; Hypothyroxinemia; Monodeiodinase; Nonthyroidal illness; Prematurity; Randomized; Thyroid hormone; Thyroxine; Transient hypothyroxinemia; Triiodothyronine

Indexed keywords

ALBUMIN; HYDROCORTISONE; IODINE; LIOTHYRONINE; PLACEBO; POTASSIUM IODIDE; THYROGLOBULIN; THYROTROPIN; THYROXINE;

ARTICLE; ARTIFICIAL VENTILATION; CLINICAL TRIAL; CONGENITAL HYPOTHYROIDISM; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE INCREASE; FEMALE; FREE LIOTHYRONINE INDEX; FREE THYROXINE INDEX; HUMAN; MAJOR CLINICAL STUDY; MALE; NECROTIZING ENTEROCOLITIS; NEWBORN; PHASE 1 CLINICAL TRIAL; PREMATURITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RETROLENTAL FIBROPLASIA;

ADMINISTRATION, ORAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; HYDROCORTISONE; INFANT, EXTREMELY LOW BIRTH WEIGHT; INFANT, NEWBORN; INFANT, PREMATURE, DISEASES; INFUSIONS, INTRAVENOUS; IODINE; MALE; SURVIVAL RATE; THYROID FUNCTION TESTS; THYROTROPIN; THYROXINE; TRIIODOTHYRONINE;

EID: 67749088228     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2008-2837     Document Type: Article

References (59)

1. March of Dimes Foundation. PeriStats. Available at: www.marchofdimes.com/ peristats. Accessed February 9, 2009
2. Centers for Disease Control and Prevention. Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment: United States, 2003. MMWR Morb Mortal Wkly Rep. 2004;53(3):57-59
3. Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the "common" neurologic disorders? Neurology. 2007;68(5):326-337
4. Lorenz JM, Wooliever DE, Jetton JR, Paneth N. A quantitative review of mortality and developmental disability in extremely premature newborns. Arch Pediatr Adolesc Med. 1998;152(5):425-435
5. Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008;358(16):1700-1711
6. Back SA, Rivkees SA. Emerging concepts in periventricular white matter injury. Semin Perinatol. 2004;28(6):405-414
7. Hack M, Flannery DJ, Schluchter M, Cartar L, Borawski E, Klein N. Outcomes in young adulthood for very-low-birth-weight infants. N Engl J Med. 2002;346(3):149-157
8. Kuban KC, Leviton A. Cerebral palsy. N Engl J Med. 1994;330(3):188-195
9. Perlman JM. Neurobehavioral deficits in premature graduates of intensive care - potential medical and neonatal environmental risk factors. Pediatrics. 2001;108(6):1339-1348
10. Sharlin DS, Tighe D, Gilbert ME, Zoeller RT. The balance between oligodendrocyte and astrocyte production in major white matter tracts is linearly related to serum total thyroxine. Endocrinology. 2008;149(5):2527-2536
11. Den Ouden AL, Kok JH, Verkerk PH, Brand R, Verloove-Vanhorick SP. The relation between neonatal thyroxine levels and neurodevelopmental outcome at age 5 and 9 years in a national cohort of very preterm and/or very low birth weight infants. Pediatr Res. 1996;39(1):142-145
12. Leviton A, Paneth N, Reuss ML, et al. Hypothyroxinemia of prematurity and the risk of cerebral white matter damage. J Pediatr. 1999;134(6):706-711
13. Lucas A, Morley R, Fewtrell MS. Low triiodothyronine concentration in preterm infants and subsequent intelligence quotient (IQ) at 8 year follow up. BMJ. 1996;312(7039):1132-1133
14. Lucas A, Rennie J, Baker BA, Morley R. Low plasma triiodothyronine concentrations and outcome in preterm infants. Arch Dis Child. 1988;63(10):1201-1206
15. Meijer WJ, Verloove-Vanhorick SP, Brand R, van den Brande JL. Transient hypothyroxinaemia associated with developmental delay in very preterm infants. Arch Dis Child. 1992;67(7):944-947
16. Osborne D. Thyroid hormone for preventing neurodevelopment impairment in preterm infants. Rev Cochrane Library. 2001;(4). Available at: http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001070/abstract. html. Accessed December 16, 2008
17. Reuss ML, Leviton A, Paneth N, Susser M. Thyroxine values from newborn screening of 919 infants born before 29 weeks' gestation. Am J Public Health. 1997;87(10):1693-1697
18. van Wassenaer AG, Kok JH, de Vijlder JJ, et al. Effects of thyroxine supplementation on neurologic development in infants born at less than 30 weeks' gestation. N Engl J Med. 1997;336(1):21-26
19. Various A. Transient Hypothyroxinemia Prematurity. Semin Perinatol. LaGamma EF, ed. December 2008;32(6):377-446
20. Fisher DA. Thyroid function and dysfunction in premature infants. Pediatr Endocrinol Rev. 2007; 4(4):317-328
21. Kok JH, Briet JM, van Wassenaer AG. Postnatal thyroid hormone replacement in very preterm infants. Semin Perinatol. 2001;25(6):417-425
22. Morreale de Escobar G, Obregon MJ, Escobar del Rey F. Is neuropsychological development related to maternal hypothyroidism or to maternal hypothyroxinemia? J Clin Endocrinol Metab. 2000;85(11):3975-3987
23. Morreale de Escobar G, Obregon MJ, Escobar del Rey F. Role of thyroid hormone during early brain development. Eur J Endocrinol. 2004;151(suppl 3):U25-U37
24. La Gamma EF, van Wassenaer AG, Golombek SG, et al. Neonatal thyroxine supplementation for transient hypothyroxinemia of prematurity: beneficial or detrimental? Treat Endocrinol. 2006; 5(6):335-346
25. Rapaport R, Rose SR, Freemark M. Hypothyroxinemia in the preterm infant: the benefits and risks of thyroxine treatment. J Pediatr. 2001;139(2):182-188
26. Anselmo J, Cao D, Karrison T, Weiss RE, Refetoff S. Fetal loss associated with excess thyroid hormone exposure. JAMA. 2004;292(6):691-695
27. Kempers MJ, van Trotsenburg AS, van Tijn DA, et al. Disturbance of the fetal thyroid hormone state has long-term consequences for treatment of thyroidal and central congenital hypothyroidism. J Clin Endocrinol Metab. 2005;90(7):4094-4100
28. Kopp P, van Sande J, Parma J, et al. Brief report: congenital hyperthyroidism caused by a mutation in the thyrotropin-receptor gene. N Engl J Med. 1995;332(3):150-154
29. Fish LH, Schwartz HL, Cavanaugh J, Steffes MW, Bantle JP, Oppenheimer JH. Replacement dose, metabolism, and bioavailability of levothyroxine in the treatment of hypothyroidism: role of triiodothyronine in pituitary feedback in humans. N Engl J Med. 1987;316(13):764-770
30. Golombek SFM, Corbi D, LaGamma EF. Stability of thyroid hormones on a continuous infusion. Presented at the 13th International Thyroid Congress; October 30-November 4, 2005; Buenos Aires, Argentina
31. Surks MI, Sievert R. Drugs and thyroid function. N Engl J Med. 1995;333(25):1688-1694
32. Bell MJ, Ternberg JL, Feigin RD, et al. Neonatal necrotizing enterocolitis: therapeutic decisions based upon clinical staging. Ann Surg. 1978;187(1):1-7
33. An international classification of retinopathy of prematurity. Pediatrics. 1984;74(1):127-133
34. Mishra R, Golombek SG, Ramirez-Tolentino SR, Das S, La Gamma EF. Low-birth-weight neonates exhibit a physiological set-point to regulate CO2: an untapped potential to minimize volutrauma-associated lung injury. Am J Perinatol. 2003;20(8):453-463
35. Brumberg H, La Gamma EF. New perspectives on nutrition enhance outcomes for premature infants. Pediatr Ann. 2003;32(9):617-625
36. La Gamma EF, Browne LE. Feeding practices for infants weighing less than 1500 g at birth and the pathogenesis of necrotizing enterocolitis. Clin Perinatol. 1994;21(2):271-306
37. Omar SA, DeCristofaro JD, Agarwal BI, La Gamma EF. Effects of prenatal steroids on water and sodium homeostasis in extremely low birth weight neonates. Pediatrics. 1999;104(3 pt 1):482-488
38. Omar SA, DeCristofaro JD, Agarwal BI, LaGamma EF. Effect of prenatal steroids on potassium balance in extremely low birth weight neonates. Pediatrics. 2000;106(3):561-567
39. Conrad SC, Chiu H, Silverman BL. Soy formula complicates management of congenital hypothyroidism. Arch Dis Child. 2004;89(1):37-40
40. Nelson J, Yoo E, Wilcox R. Accuracy issues in free thyroxine testing methods. Semin Perinatol. 2008;32(6):403-406
41. Williams FL, Simpson J, Delahunty C, et al. Developmental trends in cord and postpartum serum thyroid hormones in preterm infants. J Clin Endocrinol Metab. 2004;89(11):5314-5320
42. Williams FL, Ogston SA, van Toor H, Visser TJ, Hume R. Serum thyroid hormones in preterm infants: associations with postnatal illnesses and drug usage. J Clin Endocrinol Metab. 2005;90(11): 5954-5963
43. Simpson J, Williams FL, Delahunty C, et al. Serum thyroid hormones in preterm infants and relationships to indices of severity of intercurrent illness. J Clin Endocrinol Metab. 2005;90(3): 1271-1279
44. Mercado M, Yu VY, Francis I, Szymonowicz W, Gold H. Thyroid function in very preterm infants. Early Hum Dev. 1988;16(2-3):131-141
45. Rapoport B, DeGroot LJ. Current concepts of thyroid physiology. Semin Nucl Med. 1971;1(3): 265-286
46. Mitchell ML, Walraven C, Rojas DA, McIntosh KF, Hermos RJ. Screening very-low-birthweight infants for congenital hypothyroidism. Lancet. 1994;343(8888):60-61
47. Anderson GW, Schoonover CM, Jones SA. Control of thyroid hormone action in the developing rat brain. Thyroid. 2003;13(11):1039-1056
48. Bernal J, Guadano-Ferraz A, Morte B. Perspectives in the study of thyroid hormone action on brain development and function. Thyroid. 2003;13(11):1005-1012
49. Reuss ML, Paneth N, Pinto-Martin JA, Lorenz JM, Susser M. The relation of transient hypothyroxinemia in preterm infants to neurologic development at two years of age. N Engl J Med. 1996; 334(13):821-827
50. De Groot LJ. Dangerous dogmas in medicine: the nonthyroidal illness syndrome. J Clin Endocrinol Metab. 1999;84(1):151-164
51. Kahaly GJ, Dillmann WH. Thyroid hormone action in the heart. Endocr Rev. 2005;26(5):704-728
52. Schönberger W, Grimm W, Emmrich P, Gempp W. Reduction of mortality rate in premature infants by substitution of thyroid hormones. Eur J Pediatr. 1981;135(3):245-253
53. van Trotsenburg AS, Vulsma T, van Rozenburg-Marres SL, et al. The effect of thyroxine treatment started in the neonatal period on development and growth of two-year-old Down syndrome children: a randomized clinical trial. J Clin Endocrinol Metab. 2005;90(6):3304-3311
54. Köhler B, Schnabel D, Biebermann H, Gruters A. Transient congenital hypothyroidism and hyperthyrotropinemia: normal thyroid function and physical development at the ages of 6-14 years. J Clin Endocrinol Metab. 1996;81(4):1563-1567
55. Rovet J. Congenital hypothyroidism: treatment and outcome. Curr Opin Endocrinol Diabetes Obes. 2005;12(1):42-52
56. Tillotson SL, Fuggle PW, Smith I, Ades AE, Grant DB. Relation between biochemical severity and intelligence in early treated congenital hypothyroidism: a threshold effect. BMJ. 1994;309(6952): 440-445
57. van Wassenaer AG, Kok JH, Dekker FW, Endert E, de Vijlder JJ. Thyroxine administration to infants of less than 30 weeks gestational age decreases plasma tri- iodothyronine concentrations. Eur J Endocrinol. 1998;139(5):508-515
58. Rovet J, Simic N. The role of transient hypothyroxinemia of prematurity in development of visual abilities. Semin Perinatol. 2008;32(6):431-437
59. Amato M, Pasquier S, Carasso A, Von Muralt G. Postnatal thyroxine administration for idiopathic respiratory distress syndrome in preterm infants. Horm Res. 1988;29(1):27-30