title: Prediction of Human Glomerular Filtration Rate from Preterm Neonates to Adults: Evaluation of Predictive Performance of Several Empirical Models.
abstract: The objective of this study was to evaluate the predictive performance of several allometric empirical models (body weight dependent, age dependent, fixed exponent 0.75, a data-dependent single exponent, and maturation models) to predict glomerular filtration rate (GFR) in preterm and term neonates, infants, children, and adults without any renal disease. In this analysis, the models were developed from GFR data obtained from inulin clearance (preterm neonates to adults; n = 93) and the predictive performance of these models were evaluated in 335 subjects (preterm neonates to adults). The primary end point was the prediction of GFR from the empirical allometric models and the comparison of the predicted GFR with measured GFR. A prediction error within ±30% was considered acceptable. Overall, the predictive performance of the four models (BDE, ADE, and two maturation models) for the prediction of mean GFR was good across all age groups but the prediction of GFR in individual healthy subjects especially in neonates and infants was erratic and may be clinically unacceptable.
authors.affiliation: Division of Hematology Clinical Review Branch, Office of Blood Review & Research (OBRR), Center for Biologic Evaluation and Research, Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993-0002, USA. Iftekhar.mahmood@fda.hhs.gov.
authors.forename: Iftekhar
authors.initials: I
authors.lastname: Mahmood
authors.affiliation: Division of Hematology Clinical Review Branch, Office of Blood Review & Research (OBRR), Center for Biologic Evaluation and Research, Food & Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993-0002, USA.
authors.forename: Carl-Michael
authors.initials: CM
authors.lastname: Staschen
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D036262:Empirical Research; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology*; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D011237:Predictive Value of Tests
keywords: GFR; allometry; pediatrics