Antibiotic Stewardship and Protection of the Developing Preterm Infant Microbiome



Status:Recruiting
Conditions:Colitis, Women's Studies, Gastrointestinal
Therapuetic Areas:Gastroenterology, Reproductive
Healthy:No
Age Range:Any
Updated:5/14/2016
Start Date:July 2015
Contact:Nicole Grady, MD
Email:nicole.grady@uchospitals.edu
Phone:773-702-6210

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The purpose of this study is to determine whether antibiotics given immediately after birth
alter the development of the developing preterm infant's microbiome, which may further alter
overall clinical outcomes.


Inclusion Criteria for antibiotic randomization:

1. Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks

-AND-

2. Infant must be born at investigator's home institution.

-AND-

3. Infant must be considered to have a low risk of infection by one of the following
criteria:

1. Delivered for maternal indications (Cesarean section or induction of labor for
maternal health, including pre-eclampsia, placental abruption, history of
intrauterine fetal demise (IUFD)/abruption, multiple gestation requiring preterm
delivery, etc) -OR-

2. Delivered due to preterm labor to a mother without the diagnosis of
chorioamnionitis/maternal fever or prolonged rupture of membranes >18 hours

Exclusion Criteria for antibiotic randomization:

1. Signs of clinical illness within the first 3 hours of life:

1. 5-minute Apgar <5

2. Requiring vasoactive drugs

3. Seizures

4. Significant respiratory distress requiring supplemental oxygen >40%

2. Immature:Total (I:T) Ratio of >0.2 on initial complete blood count (CBC)

3. Congenital anomalies, including renal anomalies requiring serum antibiotic level
monitoring

ANY infant born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks who do not
meet inclusion criteria, with parental consent, can participate in the stool analysis only
arm of the study.
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