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Antibiotic Stewardship and Protection of the Developing Preterm Infant Microbiome

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Birth of Newborn; Enterocolitis, Necrotizing

Intervention: Ampicillin (Drug); Gentamicins (Drug); Placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Chicago

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

Summary

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.

Clinical Details

Official title: Antibiotic Stewardship and Protection of the Developing Preterm Infant Microbiome

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Development of the preterm infant microbiome

Secondary outcome:

Clinical outcome - Chronic Lung Disease (CLD)

Clinical outcome - Retinopathy of Prematurity (ROP)

Clinical outcome - Intraventricular Hemorrhage (IVH)

Clinical outcome - Necrotizing enterocolitis

Clinical outcome - Death

Length of hospital stay

Number of days from birth to initiation of feeds will be determined from the medical record

Type of feeds (formula compared to breastmilk) during hospitalization.

The number of times that feeds are held/discontinued due to feeding intolerance will be determined from the medical record.

The total number of days the infant is on antibiotics will be determined from the medical record at the time of discharge.

Eligibility

Minimum age: N/A. Maximum age: 6 Hours. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: June 2015
Last updated: June 19, 2015

Page last updated: August 23, 2015

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