Status:
COMPLETED
Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Penn State University
Conditions:
Infant Development
Eligibility:
All Genders
Brief Summary
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), anti...
Detailed Description
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1)...
Eligibility Criteria
Inclusion
- full-term infant (\> 36 0/7 weeks gestational age) without significant morbidity
- nursery/NICU/maternity stay of 7 days or less
- participant children can be (but do not have to be) twins
- English speaking mother
- care provided at an HMC affiliated clinic
- a working telephone number
Exclusion
- prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- infant birth weight \<2250 grams
- presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.
- plan for newborn to be adopted
- plan to move from Central Pennsylvania within 1 year
- have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
Key Trial Info
Start Date :
July 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03236194
Start Date
July 17 2017
End Date
January 30 2019
Last Update
March 4 2019
Active Locations (1)
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1
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033