Trial · NCT02477423
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
NCT02477423, Not applicable, Completed, University of Chicago; results first posted 2020-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome. Trials, record NCT02477423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477423
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
- NCT number
- NCT02477423
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 27 participants, actual
- Lead sponsor
- University of Chicago
- Conditions
- Premature Birth of Newborn, Enterocolitis, Necrotizing
- Interventions
- Ampicillin, Gentamicins, Placebo
- First posted
- 2015-06-22
- Last updated
- 2020-10-08
- Results first posted
- 2020-09-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Richness of the Preterm Infant Microbiome | 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. |
| Primary | Shannon Diversity of the Preterm Infant Microbiome | 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. |
| Secondary | Chronic Lung Disease of Infancy (CLD) | 4-12 weeks | Premature infants who require \> 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation |
| Secondary | Necrotizing Enterocolitis (NEC) | 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). |
| Secondary | Retinopathy of Prematurity (ROP) | 4-12 weeks | Cases of ROP as diagnosed by the pediatric ophthalmologist |
| Secondary | Intraventricular Hemorrhage (IVH) | 4-12 weeks | Cases of IVH present on any head ultrasound obtained during patient's hospitalization |
| Secondary | Death | 18 months |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Richness of the Preterm Infant Microbiome | 2 weeks | 16S rRNA gene amplicon sequence variants | MEAN | |
| PRIMARY | Shannon Diversity of the Preterm Infant Microbiome | 2 weeks | Shannon diversity | MEAN | |
| SECONDARY | Chronic Lung Disease of Infancy (CLD) | 4-12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Necrotizing Enterocolitis (NEC) | 4-12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Retinopathy of Prematurity (ROP) | 4-12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intraventricular Hemorrhage (IVH) | 4-12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death | 18 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Richness of the Preterm Infant Microbiome | Randomized & Blinded - Receiving Antibiotics | 12.8 | Standard Deviation 5.3 | 16S rRNA gene amplicon sequence variants | |
| Richness of the Preterm Infant Microbiome | Randomized & Blinded - Receiving Placebo | 11 | Standard Deviation 6.9 | 16S rRNA gene amplicon sequence variants | |
| Shannon Diversity of the Preterm Infant Microbiome | Randomized & Blinded - Receiving Antibiotics | 5 | Standard Deviation 3.6 | Shannon diversity | |
| Shannon Diversity of the Preterm Infant Microbiome | Randomized & Blinded - Receiving Placebo | 3.8 | Standard Deviation 3.3 | Shannon diversity | |
| Chronic Lung Disease of Infancy (CLD) | Randomized & Blinded - Receiving Antibiotics | 0 | Participants | ||
| Chronic Lung Disease of Infancy (CLD) | Randomized & Blinded - Receiving Placebo | 0 | Participants | ||
| Necrotizing Enterocolitis (NEC) | Randomized & Blinded - Receiving Antibiotics | 0 | Participants | ||
| Necrotizing Enterocolitis (NEC) | Randomized & Blinded - Receiving Placebo | 0 | Participants | ||
| Retinopathy of Prematurity (ROP) | Randomized & Blinded - Receiving Antibiotics | 0 | Participants | ||
| Retinopathy of Prematurity (ROP) | Randomized & Blinded - Receiving Placebo | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Randomized & Blinded - Receiving Antibiotics | 12 | |
| Overall Study | STARTED | Randomized & Blinded - Receiving Placebo | 15 | |
| Overall Study | COMPLETED | Randomized & Blinded - Receiving Antibiotics | 11 | |
| Overall Study | COMPLETED | Randomized & Blinded - Receiving Placebo | 11 | |
| Overall Study | NOT COMPLETED | Randomized & Blinded - Receiving Antibiotics | 1 | |
| Overall Study | NOT COMPLETED | Randomized & Blinded - Receiving Placebo | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized & Blinded - Receiving Antibiotics | 0 | 12 |
| Total, all-cause mortality | Randomized & Blinded - Receiving Placebo | 0 | 15 |
| Total, other adverse events | Randomized & Blinded - Receiving Antibiotics | 0 | 12 |
| Total, other adverse events | Randomized & Blinded - Receiving Placebo | 0 | 15 |
| Total, serious adverse events | Randomized & Blinded - Receiving Antibiotics | 0 | 12 |
| Total, serious adverse events | Randomized & Blinded - Receiving Placebo | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: Necrotizing Enterocolitis (NEC) | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: Retinopathy of Prematurity (ROP) | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: Intraventricular Hemorrhage (IVH) | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: Death | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: Chronic Lung Disease of Infancy (CLD) | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: deaths from any cause | Trial comparisons |
| Randomized & Blinded - Receiving Antibiotics vs Randomized & Blinded - Receiving Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02477423
GET https://conductscience.org/api/trials/v1/NCT02477423/registered