Study of Infant Diets on Estrogen Activity and Development
|ClinicalTrials.gov Identifier: NCT00340665|
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : March 6, 2018
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 5.5 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:
- 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.
- 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, 1/2-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.
|Condition or disease|
|Infant Formula Estrogen Activity|
|Study Type :||Observational|
|Estimated Enrollment :||456 participants|
|Official Title:||Study of Estrogen Activity & Development (SEAD) SEAD2: Physical Exam and Ballard Markers; Sead 3: Biochemistry|
|Study Start Date :||May 5, 2003|
|Estimated Study Completion Date :||August 22, 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00340665
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-6056|
|Childrens Hospital, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Walter Rogan, M.D.||National Institute of Environmental Health Sciences (NIEHS)|