Systematic Search of Height and Weight Changes of Exclusively Breastfed Infants Until 1 Year of age: A Contribution

Martje Van Neste1,2, Julia Macente3, Nina Nauwelaerts3,4

  • 1Clinical pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.

Clinical Pharmacokinetics
|November 7, 2025
PubMed

Insights

Physiologically based pharmacokinetic (PBPK) models need updated infant data. This study provides new sex-specific height and weight equations for breastfed infants, improving drug exposure predictions during lactation.

Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Pediatric Pharmacology
  • Computational Biology

Background:

  • Physiologically based pharmacokinetic (PBPK) modeling predicts drug exposure in specific populations like infants.
  • Current PBPK platforms lack physiological data influenced by infant feeding types (human milk vs. formula).
  • Accurate infant PBPK models are crucial for assessing drug safety during lactation.

Purpose of the Study:

  • To develop novel, sex-specific height and weight equations for exclusively breastfed infants.
  • To incorporate these equations into PBPK platforms for improved infant modeling.
  • To compare new equations with existing PBPK software data and validate against external datasets.

Main Methods:

  • Systematic literature search to compile physiological data from 223 articles on exclusively breastfed infants.
  • Extracted and analyzed sex-specific height and weight data from 35 and 43 articles, respectively.
  • Developed mathematical equations for height and weight trajectories and compared them with existing PBPK models and Flemish data.

Main Results:

  • Compiled and analyzed sex-specific height and weight data for exclusively breastfed infants.
  • Generated novel mathematical equations describing infant height and weight trajectories.
  • Found that current PBPK software equations often overestimate height and weight for breastfed infants from 6 months onwards compared to the new equations.

Conclusions:

  • The developed equations provide a more accurate representation of exclusively breastfed infants' growth.
  • Incorporating these novel equations into PBPK platforms can enhance the accuracy of drug exposure predictions.
  • Further research into other physiological parameters (e.g., body composition) in breastfed infants is warranted for comprehensive PBPK modeling.

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