Transient Hypothyroxinemia of Prematurity Clinical Trial
Official title:
Transient Hypothyroxinemia of Prematurity: Electrophysiological Changes in the Preterm Infants' Brain, a Retrospective Study
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.
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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