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NCT00340665 · ClinicalTrials.gov registry record
Study of Infant Diets on Estrogen Activity and Development
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 239
- Enrollment target
NCT00340665 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 239 participants.
The verdict
NCT00340665 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 239 participants
- Enrollment target
Study 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 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: 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 subs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2003-05-05 |
| Est. Completion | 2012-08-22 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00340665
The ClinicalTrials.gov registry entry for NCT00340665 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00340665 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00340665 about?
NCT00340665 is a clinical study titled "Study of Infant Diets on Estrogen Activity and Development". 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...
What is the current status of trial NCT00340665?
This trial is currently completed. The enrollment target is 239 participants. The study started on 2003-05-05. Estimated completion is 2012-08-22.
Who is sponsoring clinical trial NCT00340665?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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