Status:
ACTIVE_NOT_RECRUITING
Breast Milk: Influence of the Micro-transcriptome Profile on Atopy in Children Over Time
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
The Gerber Foundation
Conditions:
Atopy
Atopic Dermatitis Eczema
Eligibility:
All Genders
Up to 7 years
Brief Summary
This is an observational cohort study of 221 breast-feeding mother-infant dyads delivered at term. The goal of the study is to investigate whether levels of immune-related microRNAs (miRNAs) in matern...
Detailed Description
Atopy is a common condition that often emerges in infancy with atopic dermatitis (AD), wheezing, or food allergies. Atopy results from a heightened immune response to environmental allergens that appe...
Eligibility Criteria
Inclusion
- Mothers between the ages of 18 years adn 35 years
- Mothers plan to breast feed for minimum of 16 weeks (cessation of breastfeeding prior to this timepoint will not result in exclusion)
- Infants delivered at term (37 - 42 weeks)
Exclusion
- Maternal morbidities that could affect ability to breastfeed or influence the breast milk micro-transcriptome (eg. cancer, drug addiction, HIV).
- Plan for infant adoption, or family move \>150 km from the medical center within 12 months of delivery
- Presence of congenital anomaly or neonatal condition that significantly affects a newborn's ability to feed (e.g. cleft lip/palate, metabolic disease, or prolonged neonatal intensive care unit (NICU) admission \>7 days)
- Plan to seek primary pediatric care outside the academic medical center
Key Trial Info
Start Date :
January 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2027
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT04017520
Start Date
January 18 2018
End Date
December 30 2027
Last Update
January 24 2025
Active Locations (1)
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1
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033