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EEG Alterations in Preterm Infants With Thyroid Dysfunction (EEG-THOP)

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ClinicalTrials.gov Identifier: NCT03493113
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment
Transient Hypothyroxinemia of Prematurity Diagnostic Test: EEG

Detailed Description:
  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.


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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Transient Hypothyroxinemia of Prematurity: Electrophysiological Changes in the Preterm Infants' Brain, a Retrospective Study
Actual Study Start Date : October 2011
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017



Primary Outcome Measures :
  1. Differences in EEG measures in preterm infants with thyroid dysfunction [ Time Frame: November 2011 - November 2017 ]
    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.


Secondary Outcome Measures :
  1. Neurodevelopmental disturbances due to THOP and predicted by EEG alterations [ Time Frame: November 2011 - November 2019 ]
    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). We will use these results and link them to the EEG findings and THOP data.



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Ages Eligible for Study:   24 Weeks to 27 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants who had EEG recordings in the framework of the Resilience study and gestational age < 28 weeks.
Criteria

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

Exclusion Criteria:

  • Presence of congenital abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493113


Locations
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Belgium
UZ Leuven, Department of Neonatology
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven

Publications of Results:

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03493113     History of Changes
Other Study ID Numbers: S61028
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitaire Ziekenhuizen Leuven:
EEG

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications