Chicago, Illinois 60637


Purpose:

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.


Criteria:

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.


NCT ID:

NCT02477423


Primary Contact:

Nicole Grady, MD
Phone: 773-702-6210
Email: nicole.grady@uchospitals.edu


Backup Contact:

Email: eclaud@peds.bsd.uchicago.edu
Erika Claud, MD
Phone: 773-702-6210


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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