Abstract
Physiologically based pharmacokinetic (PBPK) models are developed from compound‐independent information to describe important anatomical and physiological characteristics of an individual or population of interest. Modeling pediatric populations is challenging because of the rapid changes that occur during growth, particularly in the first few weeks and months after birth. Neonates who are born premature pose several unique challenges in PBPK model development. To provide appropriate descriptions for body weight (BW) and height (Ht) for age and appropriate incremental gains in PBPK models of the developing preterm and full term neonate, anthropometric measurements collected longitudinally from 1,063 preterm and 158 full term neonates were combined with 2,872 cross‐sectional measurements obtained from the NHANES 2007–2010 survey. Age‐specific polynomial growth equations for BW and Ht were created for male and female neonates with corresponding gestational birth ages of 25, 28, 31, 34, and 40 weeks. Model‐predicted weights at birth were within 20% of published fetal/neonatal reference standards. In comparison to full term neonates, postnatal gains in BW and Ht were slower in preterm subgroups, particularly in those born at earlier gestational ages. Catch up growth for BW in neonates born at 25, 28, 31, and 34 weeks gestational age was complete by 13, 8, 6, and 2 months of life (males) and by 10, 6, 5, and 2 months of life (females), respectively. The polynomial growth equations reported in this paper represent extrauterine growth in full term and preterm neonates and differ from the intrauterine growth standards that were developed for the healthy unborn fetus.
Highlights
Growth trajectories for body weight (BW) and Ht were extracted from published curves using GetData Graph Digitizer to obtain mean weight-for-age and mean height-for-age values that were reported from birth until a BW of 2000 g was reached
The compiled data sets include longitudinal measurements that were obtained from 1,063 preterm infants who were distributed among the four preterm subgroups as follows: 25 week GA (n 5 161), 28 week GA (n 5 311), 31 week GA (n 5 266), and 34 week GA (n 5 325)
With the exception of the data set by Bertino et al (2006), which reported BW data collected in Italy, all Growth period
Summary
Pharmacokinetic differences that may occur between different routes of exposure, dose levels, species, and subpopula-. | 917 assessment for neonates, infants, and children but the predictive accuracy and reliability of prospective model simulations is dependent on the ability of the model to describe accurately time-dependent changes in physiology and other variables that influence a chemical’s absorption and disposition This includes body size, tissue composition, maturation of developing organs, such as kidney and liver, and the overall impact on renal and nonrenal elimination mechanisms. McLean, 1969), the growth charts that are currently available represent cross-sectional or longitudinal intrauterine growth of healthy unborn fetuses or cross-sectional data collected at birth or during fetal or neonatal autopsy (Archie, Collins, & Lebel, 2006; Phillips, Billson, & Forbes, 2009) Both approaches are useful for intrauterine growth monitoring and evaluating nutritional status of the developing fetus but they do not capture postnatal growth patterns of infants who are born preterm (Rao & Tompkins, 2007) and how an individual may change with postnatal age and maturation triggered by birth. Such models should be informative in developing predictive models for outcomes related to pharmacokinetics and the comparison of internal concentrations to chemical toxicity and drug efficacy in the preterm neonate as well as the impact of birth as a potential biological trigger for initiating maturation
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