Early Life Feeding Exposure and Infant Immune and Health Status.

Launched by UNIVERSITY OF IDAHO · Aug 2, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Early Life Feeding Exposure and Infant Immune and Health Status," is studying how a mother's health, particularly her inflammation levels and body weight, affects the composition of her breastmilk and the immune development of her infant. The researchers want to understand how these factors might influence an infant's risk of developing obesity and other health issues as they grow. They believe that breastfed infants may have better immune responses compared to those who are formula-fed, and they aim to uncover the connections between a mother's health and her baby's long-term health outcomes.

To participate in this study, mothers need to be at least 18 years old, in their third trimester of pregnancy or have an infant 5 weeks old or younger, and plan to breastfeed or provide formula for at least 18 weeks. Participants will undergo a series of visits where they will provide samples and complete activities related to the study. This research is important because it could help improve understanding of how early-life feeding and maternal health can protect against obesity and support healthy immune development in infants. If you meet the eligibility criteria and are interested, this study could contribute valuable information to the field of infant health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.