Status:
COMPLETED
Effects of Infant Diets on Estrogen Activity and Development
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Hormone
Eligibility:
All Genders
Up to 1 years
Brief Summary
This study, conducted at the Children's Hospital of Boston and the Brigham and Women's Hospital in Boston, will examine the natural history of infant development in the first year of life and how diff...
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:
- 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:
- Breastmilk Category:
- 0-48 hours old (Age-Interval: 1) - Breastmilk exclusively;
- 49 hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Breastmilk exclusively;
- Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - Breastmilk exclusively OR Breastmilk and Cow-based formula.
- Restriction: Babies in the Breastmilk category are not allowed to have had any SOY foods including SOY formula and solid foods containing SOY in their lifetime.
- Cow-Based Formula Category:
- 0-48 hours old (Age-Interval: 1) - Cow-based formula exclusively;
- 49 hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Cow-based formula exclusively;
- Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - Cow-based formula exclusively.
- Exception: If a baby was Breastfed in the nursery, the baby must have gone home on Cow-based formula and have been on Cow-based formula exclusively ever since. Such a child cannot participate in the SEAD study until s/he has been exclusively Cow-based formula fed for at last 2 weeks.
- Restriction: Babies in the Cow-based formula category are not allowed to have had any SOY foods including SOY formula and solid foods containing SOY in their lifetime.
- Soy Formula Category:
- 0-48 hours old (Age-Interval: 1) - Soy formula exclusively;
- 49 hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Soy formula exclusively;
- Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - 2/3 of lifetime on Soy formula exclusively \& continuously, and including the two weeks up to the exam.
- Exception: If a baby was fed something other than Soy formula in the nursery, the baby must have gone home on Soy and been on Soy exclusively ever since. Such a child cannot participate in the SEAD study until s/he has been exclusively Soy-fed for at least 2 weeks.
- Birth weight between 2501 - 4499 grams.
- Age 0-12 months for girls and age 0-6 months for boys.
- EXCLUSION CRITERIA:
- Chromosomal anomalies.
- Major malformations.
- Non-palpable testis (males only).
- Presence of an endocrinopathy (i.e., ambiguous genitalia, congenital hypothyroidism).
Exclusion
Key Trial Info
Start Date :
August 26 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 22 2012
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00340652
Start Date
August 26 2003
End Date
August 22 2012
Last Update
December 17 2019
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Childrens Hospital, Boston
Boston, Massachusetts, United States, 02115