Pilot Studies of Estrogen-Related Physical Findings in Infants
2008

Study of Estrogen Effects in Infants on Soy Formula

Sample size: 72 publication Evidence: moderate

Author Information

Author(s): Judy C. Bernbaum, David M. Umbach, N. Beth Ragan, Jeanne L. Ballard, Janet I. Archer, Holly Schmidt-Davis, Walter J. Rogan

Primary Institution: Children’s Hospital of Philadelphia

Hypothesis

Does soy formula prolong the physiologic estrogenization of newborns?

Conclusion

The study found that examination of infants for plausible effects of estrogens is valid and repeatable.

Supporting Evidence

  • Breast tissue was maximal at birth and decreased with age.
  • Vaginal wall cells showed maximal estrogen effect at birth and then reverted.
  • Soy-fed girls tended to show higher vaginal maturation index at 6 months.

Takeaway

This study looked at how soy formula might affect baby boys and girls by checking their breast and genital development.

Methodology

The study involved physical examinations of infants to assess breast and genital development, measuring breast adipose tissue, breast buds, and testicular volume.

Potential Biases

Examiners were not blinded to feeding regimen, which could introduce bias.

Limitations

The study was small and primarily cross-sectional, limiting the ability to make reliable inferences about feeding regimens.

Participant Demographics

72 children, 4% Asian or Pacific Islander, 70% black not of Hispanic origin, 26% white not of Hispanic origin.

Statistical Information

P-Value

p<0.0001

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.1289/ehp.10409

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