EEG Alterations in Preterm Infants With Thyroid Dysfunction
NCT ID: NCT03493113
Last Updated: 2018-04-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
87 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-10-31
Study Completion Date
2017-10-31
Brief Summary
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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.
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Detailed Description
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1. Definition of THOP The determination of thyroid hormones (TH) are assay-specific and related to the infants' gestational age (GA) and moment of determination. Immediately after birth, there will be a surge of TH, subsequently followed by a decrease to basal levels. Therefore, it is difficult to obtain reference values.
The investigators plan to set out specific reference values for the preterm patient population, based on the TH laboratory results of cord blood, performed in the clinical laboratory of UZ Leuven and available over the last 4 years. The results will be linked to the gestational age. Dependent whether the data distribution is normal or not, the investigators are planning to use standard deviations or percentiles to classify patients.
2. EEG findings In this retrospective study, quantitative EEG- sleep behavior at (near) term age (GA 36-44 weeks) in preterm infants born \<28 weeks GA, will be analyzed (n = 87).
EEGs were taken in the framework of the Resilience study and hereby, parental informed consent was already obtained.
TH function is assessed in preterm infants ≤ 34 weeks as part of the clinical care protocol. No additional blood samples were taken.
Quantitative EEG measures will be compared between the preterm infants with THOP (circulating thyroxine levels\< P10) and without THOP. Logisitic regression will be performed to determine the effect of thyroid function as well as other clinical and demographic variables, on functional brain development at term equivalent age. These results will also be linked to long-term neurodevelopment outcome.
In a subgroup of these preterm patients (n=42) sequential EEGs, recorded during their stay at the neonatal intensive care unit, are available. These EEGs will be analyzed in a fully automatic way to assess functional EEG- brain maturation.
In this way, the investigators want to investigate whether deviations of normal preterm EEG-brain maturation can be discerned in preterm neonates with THOP and without THOP.
In preterm infants with GA \< 32 weeks, developmental follow up data are available at the corrected age of 9 months and 2 years (Follow up Convention). The investigators will use these results and link them to the EEG findings and THOP data.
The investigators plan to set out specific reference values for the preterm patient population, based on the TH laboratory results of cord blood, performed in the clinical laboratory of UZ Leuven and available over the last 4 years. The results will be linked to the gestational age. Dependent whether the data distribution is normal or not, the investigators are planning to use standard deviations or percentiles to classify patients.
2. EEG findings In this retrospective study, quantitative EEG- sleep behavior at (near) term age (GA 36-44 weeks) in preterm infants born \<28 weeks GA, will be analyzed (n = 87).
EEGs were taken in the framework of the Resilience study and hereby, parental informed consent was already obtained.
TH function is assessed in preterm infants ≤ 34 weeks as part of the clinical care protocol. No additional blood samples were taken.
Quantitative EEG measures will be compared between the preterm infants with THOP (circulating thyroxine levels\< P10) and without THOP. Logisitic regression will be performed to determine the effect of thyroid function as well as other clinical and demographic variables, on functional brain development at term equivalent age. These results will also be linked to long-term neurodevelopment outcome.
In a subgroup of these preterm patients (n=42) sequential EEGs, recorded during their stay at the neonatal intensive care unit, are available. These EEGs will be analyzed in a fully automatic way to assess functional EEG- brain maturation.
In this way, the investigators want to investigate whether deviations of normal preterm EEG-brain maturation can be discerned in preterm neonates with THOP and without THOP.
In preterm infants with GA \< 32 weeks, developmental follow up data are available at the corrected age of 9 months and 2 years (Follow up Convention). The investigators will use these results and link them to the EEG findings and THOP data.
Conditions
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Transient Hypothyroxinemia of Prematurity
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Interventions
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EEG
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* 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
* serial EEG recordings available
* thyroid function test on the first day of life and at the end of the first week of life available
Exclusion Criteria
* Presence of congenital abnormalities
Minimum Eligible Age
24 Weeks
Maximum Eligible Age
27 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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KU Leuven
OTHER
Sponsor Role
collaborator
Universitaire Ziekenhuizen KU Leuven
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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UZ Leuven, Department of Neonatology
Leuven, Vlaams-Brabant, Belgium
Site Status
Countries
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Belgium
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Other Identifiers
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S61028
Identifier Type: -
Identifier Source: org_study_id
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