Severity parameters for asphyxia or hypoxic-ischemic encephalopathy do not explain inter-individual variability in the pharmacokinetics of phenobarbital in newborns treated with therapeutic hypothermia
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F22%3A10444940" target="_blank" >RIV/00064165:_____/22:10444940 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/22:10444940
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=grepJEbewk" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=grepJEbewk</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.23736/S2724-5276.20.05740-0" target="_blank" >10.23736/S2724-5276.20.05740-0</a>
Alternative languages
Result language
angličtina
Original language name
Severity parameters for asphyxia or hypoxic-ischemic encephalopathy do not explain inter-individual variability in the pharmacokinetics of phenobarbital in newborns treated with therapeutic hypothermia
Original language description
BACKGROUND: The current study uses a population modeling approach to evaluate and quantify the impact of severity of asphyxia and hypoxic-ischemic encephalopathy (HIE) on the pharmacokinetics of phenobarbital in asphyxiated newborns treated with therapeutic hypothermia. METHODS: Included newborns received phenobarbital (the TOBY trial protocol). 120 plasma samples were available from 50 newborns, median (IQR) weight 3.3 (2.8-3.5) kg and gestational age 39 (39-40) weeks. NONMEM(R) version 7.2 was used for the data analysis. Age, body weight, sex, concomitant medications, kidney and liver function markers, as well as severity parameters of asphyxia and HIE were tested as potential covariates of pharmacokinetics of phenobarbital. Severe asphyxia was defined as pH of arterial umbilical cord blood <=7.1 and Apgar 5 <=5, and severe HIE was defined as time to normalization of amplitude-integrated electroencephalography (aEEG) >24 h. RESULTS: Weight was found to be the only statistically significant covariate for the volume of distribution. At weight of 1 kg volume of distribution was 0.91 L and for every additional kg it increased in 0.91 L. Clearance was 0.00563 L/h. No covariates were statistically significant for the clearance of phenobarbital. CONCLUSIONS: Phenobarbital dose adjustments are not indicated in the studied population, irrespective of the severity of asphyxia or HIE.
Czech name
—
Czech description
—
Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
—
OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
—
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Minerva Pediatrics
ISSN
2724-5276
e-ISSN
2724-5780
Volume of the periodical
74
Issue of the periodical within the volume
2
Country of publishing house
IT - ITALY
Number of pages
9
Pages from-to
107-115
UT code for WoS article
000795673900002
EID of the result in the Scopus database
2-s2.0-85129997611