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Status:

COMPLETED

Study of Infant Diets on Estrogen Activity and Development

Lead Sponsor:

National Institute of Environmental Health Sciences (NIEHS)

Conditions:

Infant Formula

Estrogen Activity

Eligibility:

All Genders

Up to 1 years

Brief Summary

This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different infant diets may aff...

Detailed Description

Term newborns have anatomic and sonographic evidence of in utero estrogen exposure. Over the first six months to a year of life, as the influence of maternal hormone wanes, these findings recede. Soy ...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • SEAD 2 and 3
  • Full term infants defined as age 37-41 weeks gestational age at birth. Ultrasound evidence or reliable reporting of last menstrual period (LMP) by infant's mother.
  • Can be categorized into one of the feeding definitions.
  • Birth weight between 2501-4499 grams.
  • Age 0-6 months for SEAD 2, age 0-12 months for SEAD 3
  • For SEAD 3, for 12-months age interval, subjects must not have had first haircut.
  • EXCLUSION CRITERIA:
  • SEAD 2 and 3
  • Chromosomal aberrations
  • Major malformation
  • SEAD 2: Non-palpable testis (males only)
  • Presence of an endocrinopathy (i.e., ambiguous genitalia, congenital hypothyroidism)
  • This is a natural history study and children must be healthy in order to participate in this study. Therefore, children will be excluded from the study if they are known to have chromosomal aberrations, or any major malformations or an endocrinopathy. Testicular development is an important endpoint in this study and therefore males will be excluded from SEAD 2 if the testes are not palpable.

Exclusion

    Key Trial Info

    Start Date :

    May 5 2003

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    August 22 2012

    Estimated Enrollment :

    239 Patients enrolled

    Trial Details

    Trial ID

    NCT00340665

    Start Date

    May 5 2003

    End Date

    August 22 2012

    Last Update

    November 21 2019

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104-6056

    2

    Childrens Hospital, Philadelphia

    Philadelphia, Pennsylvania, United States, 19104