EEG Alterations in Preterm Infants With Thyroid Dysfunction

NCT03493113 | Completed

• 1 other identifier: S61028
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate differences in electroencephalography (EEG) evolution between preterm infants with and without transient hypothyroxinemia of prematurity (THOP) in order to find differences in the interburst interval and the background pattern and in the maturation of the sleep-wake cycle.

Conditions

Transient Hypothyroxinemia of Prematurity

Keywords

EEG

Outcome Measures

Primary Outcomes (1)

• Differences in EEG measures in preterm infants with thyroid dysfunction

  Quantitative EEG measures will be compared between the preterm infants with THOP (circulating T4 level\< P10) and without THOP. In a subgroup of these preterm patients (n=42) sequential EEGs, recorded during their stay at the NICU, are available. These EEGs will be analyzed in a fully automatic way to assess functional EEG- brain maturation.

  November 2011 - November 2017

Secondary Outcomes (1)

• Neurodevelopmental disturbances due to THOP and predicted by EEG alterations

  November 2011 - November 2019

Interventions

EEG DIAGNOSTIC_TEST

Eligibility Criteria

• Age: 24 Weeks - 27 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants who had EEG recordings in the framework of the Resilience study and gestational age \< 28 weeks.

You may qualify if:

• gestational age \< 28 weeks
• serial EEG recordings available
• thyroid function test on the first day of life and at the end of the first week of life available

You may not qualify if:

• Presence of congenital abnormalities

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven, Department of Neonatology

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (19)

• La Gamma EF, Paneth N. Clinical importance of hypothyroxinemia in the preterm infant and a discussion of treatment concerns. Curr Opin Pediatr. 2012 Apr;24(2):172-80. doi: 10.1097/MOP.0b013e32835067cc.

  PMID: 22273635 RESULT

• 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 Mar 28;334(13):821-7. doi: 10.1056/NEJM199603283341303.

  PMID: 8596548 RESULT

• Leviton A, Paneth N, Reuss ML, Susser M, Allred EN, Dammann O, Kuban K, Van Marter LJ, Pagano M. Hypothyroxinemia of prematurity and the risk of cerebral white matter damage. J Pediatr. 1999 Jun;134(6):706-11. doi: 10.1016/s0022-3476(99)70285-4.

  PMID: 10356138 RESULT

• Auso E, Lavado-Autric R, Cuevas E, Del Rey FE, Morreale De Escobar G, Berbel P. A moderate and transient deficiency of maternal thyroid function at the beginning of fetal neocorticogenesis alters neuronal migration. Endocrinology. 2004 Sep;145(9):4037-47. doi: 10.1210/en.2004-0274. Epub 2004 Apr 15.

  PMID: 15087434 RESULT

• Santisteban P, Bernal J. Thyroid development and effect on the nervous system. Rev Endocr Metab Disord. 2005 Aug;6(3):217-28. doi: 10.1007/s11154-005-3053-9. No abstract available.

  PMID: 16151626 RESULT

• Fisher DA. Thyroid system immaturities in very low birth weight premature infants. Semin Perinatol. 2008 Dec;32(6):387-97. doi: 10.1053/j.semperi.2008.09.003.

  PMID: 19007675 RESULT

• Shellhaas RA, Burns JW, Barks JD, Chervin RD. Quantitative sleep stage analyses as a window to neonatal neurologic function. Neurology. 2014 Feb 4;82(5):390-5. doi: 10.1212/WNL.0000000000000085. Epub 2014 Jan 2.

  PMID: 24384644 RESULT

• Scher MS, Loparo KA. Neonatal EEG/sleep state analyses: a complex phenotype of developmental neural plasticity. Dev Neurosci. 2009;31(4):259-75. doi: 10.1159/000216537. Epub 2009 Jan 2.

  PMID: 19546563 RESULT

• Koolen N, Dereymaeker A, Rasanen O, Jansen K, Vervisch J, Matic V, Naulaers G, De Vos M, Van Huffel S, Vanhatalo S. Early development of synchrony in cortical activations in the human. Neuroscience. 2016 May 13;322:298-307. doi: 10.1016/j.neuroscience.2016.02.017. Epub 2016 Feb 11.

  PMID: 26876605 RESULT

• Shellhaas RA, Burns JW, Hassan F, Carlson MD, Barks JDE, Chervin RD. Neonatal Sleep-Wake Analyses Predict 18-month Neurodevelopmental Outcomes. Sleep. 2017 Nov 1;40(11):zsx144. doi: 10.1093/sleep/zsx144.

  PMID: 28958087 RESULT

• Scher MS, Steppe DA, Banks DL. Prediction of lower developmental performances of healthy neonates by neonatal EEG-sleep measures. Pediatr Neurol. 1996 Feb;14(2):137-44. doi: 10.1016/0887-8994(96)00013-6.

  PMID: 8703226 RESULT

• Niemarkt HJ, Jennekens W, Maartens IA, Wassenberg T, van Aken M, Katgert T, Kramer BW, Gavilanes AW, Zimmermann LJ, Bambang Oetomo S, Andriessen P. Multi-channel amplitude-integrated EEG characteristics in preterm infants with a normal neurodevelopment at two years of corrected age. Early Hum Dev. 2012 Apr;88(4):209-16. doi: 10.1016/j.earlhumdev.2011.08.008. Epub 2011 Sep 15.

  PMID: 21924567 RESULT

• Niemarkt HJ, Jennekens W, Pasman JW, Katgert T, Van Pul C, Gavilanes AW, Kramer BW, Zimmermann LJ, Bambang Oetomo S, Andriessen P. Maturational changes in automated EEG spectral power analysis in preterm infants. Pediatr Res. 2011 Nov;70(5):529-34. doi: 10.1203/PDR.0b013e31822d748b.

  PMID: 21772227 RESULT

• Khedr EM, El Toony LF, Tarkhan MN, Abdella G. Peripheral and central nervous system alterations in hypothyroidism: electrophysiological findings. Neuropsychobiology. 2000 Jan;41(2):88-94. doi: 10.1159/000026638.

  PMID: 10644929 RESULT

• Fisher DA, Odell WD. Acute release of thyrotropin in the newborn. J Clin Invest. 1969 Sep;48(9):1670-7. doi: 10.1172/JCI106132.

  PMID: 5822577 RESULT

• Williams FL, Simpson J, Delahunty C, Ogston SA, Bongers-Schokking JJ, Murphy N, van Toor H, Wu SY, Visser TJ, Hume R; Collaboration from the Scottish Preterm Thyroid Group. Developmental trends in cord and postpartum serum thyroid hormones in preterm infants. J Clin Endocrinol Metab. 2004 Nov;89(11):5314-20. doi: 10.1210/jc.2004-0869.

  PMID: 15531476 RESULT

• Dereymaeker A, Pillay K, Vervisch J, Van Huffel S, Naulaers G, Jansen K, De Vos M. An Automated Quiet Sleep Detection Approach in Preterm Infants as a Gateway to Assess Brain Maturation. Int J Neural Syst. 2017 Sep;27(6):1750023. doi: 10.1142/S012906571750023X. Epub 2017 Feb 24.

  PMID: 28460602 RESULT

• Stevenson NJ, Oberdorfer L, Koolen N, O'Toole JM, Werther T, Klebermass-Schrehof K, Vanhatalo S. Functional maturation in preterm infants measured by serial recording of cortical activity. Sci Rep. 2017 Oct 11;7(1):12969. doi: 10.1038/s41598-017-13537-3.

  PMID: 29021546 RESULT

• Dereymaeker A, Koolen N, Jansen K, Vervisch J, Ortibus E, De Vos M, Van Huffel S, Naulaers G. The suppression curve as a quantitative approach for measuring brain maturation in preterm infants. Clin Neurophysiol. 2016 Aug;127(8):2760-2765. doi: 10.1016/j.clinph.2016.05.362. Epub 2016 Jun 8.

  PMID: 27417049 RESULT

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: April 10, 2018
• Study Start: October 1, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 10, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)