Related Experiment Video
Updated: May 14, 2026

Breast Milk Enhances Growth of Enteroids: An Ex Vivo Model of Cell Proliferation
Published on: February 15, 2018
Evaluation of growth and early infant feeding: a challenge for scientists, industry and regulatory bodies
Ferdinand Haschke1, Philipp Steenhout, Dominik Grathwohl
1Nestle Nutrition Institute, Vevey, Switzerland. ferdinand.haschke@nestle.com
Insights
Infant formula trials require growth studies for safety and efficacy. Using the WHO growth standard is crucial, especially for at-risk populations, to accurately assess infant development.
Area of Science:
- Pediatrics
- Nutrition Science
- Clinical Trials
Background:
- Growth studies are essential for evaluating infant formula safety and efficacy.
- Randomized clinical trials following healthy infants up to 4-6 months are standard practice.
- Breastfed reference groups are necessary as formula-fed infant growth can differ.
Purpose of the Study:
- To highlight the necessity of growth studies for infant formula evaluation.
- To discuss the appropriate use and limitations of the World Health Organization (WHO) growth standard.
- To emphasize the importance of using the WHO standard in trials involving at-risk infant populations.
Main Methods:
- Review of existing meta-analyses and growth references.
- Comparison of infant growth data between formula-fed and breastfed groups.
- Consideration of specific populations, such as infants of overweight mothers.
Main Results:
- The WHO growth standard, based on breastfed infants, shows higher weight-for-age than other references up to 6 months.
- Meta-analyses suggest breastfed reference groups and infants on low-protein formula may show lower weight and BMI compared to the WHO standard.
- Infants of overweight/obese mothers or those at risk for malnutrition require careful monitoring.
Conclusions:
- The WHO growth standard is a key reference for infant formula trials.
- Understanding the limitations of the WHO standard is vital for accurate interpretation of growth data.
- The WHO standard is recommended for documenting the safety of infant formulas, particularly in at-risk populations.
Abstract:
Growth studies are necessary to prove safety and efficacy of new or renovated infant formulas. Healthy infants need to be followed in randomized clinical trials until 4-6 months of age. Breastfed reference groups should be included in such studies, because growth of formula-fed infants may deviate from breastfed infants. The WHO growth standard describes growth of exclusively or predominantly breastfed infants and is frequently used as reference. However, the limitations of the standard must be known because weight-for-age until 6 months is higher than in all international growth references. Meta-analyses indicate that both weight and BMI of breastfed reference groups in clinical trials and of infants fed a low protein formula are somehow lower than the WHO standard. Infants of overweight and obese mothers or at risk for malnutrition are considered as at-risk populations. Any infant formula trial in those populations should use the WHO standard to document safety.
Related Concept Videos
Development of Human Microbiota
Development of the Oral Microbiota
Regulation of Food Intake
Drug Regulation
Microbial Growth Measurement: Indirect Methods
Designing Growth Media for Bioreactors

