A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
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ClinicalTrials.gov Identifier: NCT02477423 |
Recruitment Status :
Completed
First Posted : June 22, 2015
Results First Posted : September 3, 2020
Last Update Posted : October 8, 2020
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Condition or disease | Intervention/treatment | Phase |
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Premature Birth of Newborn Enterocolitis, Necrotizing | Drug: Ampicillin Drug: Gentamicins Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome |
Study Start Date : | July 2015 |
Actual Primary Completion Date : | June 2019 |
Actual Study Completion Date : | June 2019 |
Arm | Intervention/treatment |
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Active Comparator: Randomized & Blinded - Receiving Antibiotics
The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive routine ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.
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Drug: Ampicillin
Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization. Drug: Gentamicins Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization. |
Placebo Comparator: Randomized & Blinded - Receiving Placebo
The infants within this arm of the study meet the inclusion criteria as being low risk. They will be randomized to receive placebo (saline) in place of ampicillin and gentamicin for the initial 48 hours of their life as a routine rule-out sepsis. Stool samples will be collected throughout hospitalization and at 18 months of life.
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Drug: Placebo
Normal saline will be given as placebo for those in the placebo comparator group. |
- Richness of the Preterm Infant Microbiome [ Time Frame: 2 weeks ]Number of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) detected in each sample. A higher richness means that a higher number of species of archaea and bacteria was detected in a sample.
- Shannon Diversity of the Preterm Infant Microbiome [ Time Frame: 2 weeks ]Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.
- Chronic Lung Disease of Infancy (CLD) [ Time Frame: 4-12 weeks ]Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation
- Necrotizing Enterocolitis (NEC) [ Time Frame: 4-12 weeks ]Any patient showing signs/symptoms of this acute neonatal gastrointestinal disease, including abdominal distension, bloody stools, systemic illness, and radiographic changes (pneumatosis intestinalis, portal venous gas, free intraperitoneal gas).
- Retinopathy of Prematurity (ROP) [ Time Frame: 4-12 weeks ]Cases of ROP as diagnosed by the pediatric ophthalmologist
- Intraventricular Hemorrhage (IVH) [ Time Frame: 4-12 weeks ]Cases of IVH present on any head ultrasound obtained during patient's hospitalization
- Death [ Time Frame: 18 months ]

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Ages Eligible for Study: | up to 6 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for antibiotic randomization:
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Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks
-AND-
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Infant must be born at investigator's home institution.
-AND-
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Infant must be considered to have a low risk of infection by one of the following criteria:
- 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-
- 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:
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Signs of clinical illness within the first 3 hours of life:
- 5-minute Apgar <5
- Requiring vasoactive drugs
- Seizures
- Significant respiratory distress requiring supplemental oxygen >40%
- Immature:Total (I:T) Ratio of >0.2 on initial complete blood count (CBC)
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477423
United States, Illinois | |
University of Chicago Medical Center - Comer Children's Hospital | |
Chicago, Illinois, United States, 60637 |
Documents provided by University of Chicago:
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT02477423 |
Other Study ID Numbers: |
IRB15-0053 |
First Posted: | June 22, 2015 Key Record Dates |
Results First Posted: | September 3, 2020 |
Last Update Posted: | October 8, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Microbiome Antibiotics |
Enterocolitis Enterocolitis, Necrotizing Premature Birth Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Obstetric Labor, Premature Obstetric Labor Complications |
Pregnancy Complications Gentamicins Ampicillin Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |