Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life

Completed

Conditions studied: Infant Development

In brief

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), antibiotic exposure, GERD medication exposure.

Key facts

Study ID

NCT03236194

Run by

Milton S. Hershey Medical Center

People needed

100

Starts

2017-07-17

Expected to finish

2019-01-30

Last updated by the study team

2019-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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