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

Penn State Health

Status: Completed

Conditions: Infant Development

Study type: Observational

Funder types: Other

Identifiers

NCT03236194

PRAMS034493EP

Details and patient eligibility

About

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.

Full 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) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.

This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.

Enrollment: 100 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. full-term infant (> 36 0/7 weeks gestational age) without significant morbidity
2. nursery/NICU/maternity stay of 7 days or less
3. participant children can be (but do not have to be) twins
4. English speaking mother
5. care provided at an HMC affiliated clinic
6. a working telephone number

Exclusion criteria

1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)
2. infant birth weight <2250 grams
3. presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
4. 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.
5. plan for newborn to be adopted
6. plan to move from Central Pennsylvania within 1 year
7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)