Status:
RECRUITING
Early Life Feeding Exposure and Infant Immune and Health Status.
Lead Sponsor:
University of Idaho
Conditions:
Maternal Behavior
Maternal Obesity
Eligibility:
FEMALE
18+ years
Brief Summary
Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but ...
Detailed Description
The immune system of newborns is immature and undergoes rapid development during the first few months of life. Inflammation is a natural response to infection or tissue injury, but excessive or prolon...
Eligibility Criteria
Inclusion
- Mother at least 18 years of age
- Mother is in third trimester (week 27 of gestation) or biological infant is 5 weeks of age or younger
- Mother plans to continue to provide your infant breastmilk (by breastfeeding or by pumping) for at least 18 weeks (4.5 months) from your delivery date or mother plans to continue to provide formula exclusively to infant for at least 18 weeks of life.
- Mother lives within a 45-mile radius of Study Site, or is willing to deliver samples for visits 2, 4, and 6.
- Mother willing to meet at (designated sample collection site) for visits 3 and 5 for sample collection and visit activities.
- Mother willing to consent and comply with all aspects of the study protocol and methods, save the optional activities and optional sample collections.
- Mother and infant are considered healthy by Principle Investigator.
- For Formula Fed Group: Mother-Infant dyad is able to match to a Breastfed dyad using maternal BMI and infant sex.
Exclusion
- Mother or Infant have participated or are currently participating in an interventional drug or device (non-observational) research study before.
- Mother reports that they, or the infant, have had an adverse effect during a venous blood collection.
- Infant was born less than 36 weeks of gestation.
- Infant or mother have health conditions that increase the risk of study procedures.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05986539
Start Date
January 12 2024
End Date
April 30 2025
Last Update
July 26 2024
Active Locations (1)
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1
University of Idaho
Moscow, Idaho, United States, 83844