Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340665
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2006-06-19
Brief Title:
Study of Infant Diets on Estrogen Activity and Development
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Estrogen Activity Development SEAD SEAD2 Physical Exam and Ballard Markers Sead 3 Biochemistry
Status:
COMPLETED
Status Verified Date:
2012-08-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 affect estrogen activity in babies During pregnancy babies are exposed to the female hormone estrogen from their mother Estrogen plays a key role in the development of breasts and milk production as well as the development of the uterus The effects of these hormones can be seen when babies are examined Between 6 and 12 months of age the effects are reduced Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects
This study has two parts Part 1 studies the physical development of babies fed different ways Part 2 studies how hormone levels in babies differ depending on what they are being fed Babies may participate in one or both parts Part 1 includes babies 0 to 6 months of age part 2 includes babies 0 to 12 months of age In each part of the study parents may choose to have their babies evaluated from one to four times
Full-term infants age 37 to 41 weeks gestational age from birth to 12 months of age who weigh from 2501 to 4499 grams about 55 to 10 pounds at birth and who have no chromosomal abnormalities major malformations or endocrine problems may be eligible for this study Male infants must have palpable testes Infants being fed a diet of breast milk soy milk or cow s milk will be included Study procedures include the following
Part 1
Feeding history the parent provides information about the baby s dietary intake since birth
Length weight and head circumference the baby s measurements are taken
Physical examination the baby s physical maturity is assessed by examination of the skin breasts and external sex organs
Breast secretions the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life If the substance appears a specimen will be collected
Vaginal cells for baby girls the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining
Part 2
Feeding history and length weight and head circumference measurements as described above
Urine a urine sample is collected in a cotton diaper or a urine collection bag
aliva a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk
Hair a lock of hair 12-inch wide and 1 to 2 inches long is taken from 12-month old babies
Blood some infants have a small blood sample collected by a heel-stick
This study will serve as a basis for a later study about how infant formulas affect infant growth
This study has two parts Part 1 studies the physical development of babies fed different ways Part 2 studies how hormone levels in babies differ depending on what they are being fed Babies may participate in one or both parts Part 1 includes babies 0 to 6 months of age part 2 includes babies 0 to 12 months of age In each part of the study parents may choose to have their babies evaluated from one to four times
Full-term infants age 37 to 41 weeks gestational age from birth to 12 months of age who weigh from 2501 to 4499 grams about 55 to 10 pounds at birth and who have no chromosomal abnormalities major malformations or endocrine problems may be eligible for this study Male infants must have palpable testes Infants being fed a diet of breast milk soy milk or cow s milk will be included Study procedures include the following
Part 1
Feeding history the parent provides information about the baby s dietary intake since birth
Length weight and head circumference the baby s measurements are taken
Physical examination the baby s physical maturity is assessed by examination of the skin breasts and external sex organs
Breast secretions the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life If the substance appears a specimen will be collected
Vaginal cells for baby girls the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining
Part 2
Feeding history and length weight and head circumference measurements as described above
Urine a urine sample is collected in a cotton diaper or a urine collection bag
aliva a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk
Hair a lock of hair 12-inch wide and 1 to 2 inches long is taken from 12-month old babies
Blood some infants have a small blood sample collected by a heel-stick
This study will serve as a basis for a later study about how infant formulas affect infant growth
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 infant formula contains large amounts of isoflavones diadzein and genistein that can occupy estrogen receptors and act as estrogens in the laboratory A food substance with estrogen activity might prolong the effect of maternal hormones or interfere with hormonal homeostasis the child Two cross-sectional pilot study SEAD 2 and SEAD 3 will be undertaken in order to establish the methods for a future multi-center study designed to assess the potential effects of soy formula on estrogen activity in infants Another cross-sectional pilot study SEAD 1 will be undertaken to evaluate anatomical evidence detected by ultrasound and will be conducted at The Childrens Hospital in Boston Details of the SEAD 1 study will not be presented in this protocol In the first pilot study SEAD 2 84 examinations of full-term infants ages 0-6 months and on one of three feeding regimens soy formula breast milk or cows milk formula will be conducted This study will establish a protocol for examining and sampling methods to be used for a later trial investigating whether exposure to soy estrogen compared to breast milk and non-soy formulas prolongs anatomical evidence of estrogen exposure and response In addition to the physical examination vaginal cells will be collected for cytology analysis Breast nipple secretions if present will also be collected and analyzed for protein and sugar levels In the second pilot study SEAD 3 372 evaluations on full-term infants will be conducted in parallel with the first study SEAD 3 will assess the hormonal and biochemical status of full-term infants age 0-12 months This study will establish a protocol for sampling methods to be used for collecting urine saliva serum and hair samples Endogenous hormone levels such as testosterone estradiol and isoflavone levels genestein and diadzein will be measured in serum and the results will be compared against the non-serum tests urine saliva and hair The purpose of these two pilot studies is twofold The first is to develop and finalize recruitment and collections procedures in preparation for a larger comprehensive trial of biological response in children to soy formula with and without the estrogenic isoflavones The second is to study the natural history of estrogen activity in infants on a variety of feeding regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-E-N184 | None | None | None |