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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized & Blinded - Receiving Antibiotics | Active Comparator | 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. |
|
| Randomized & Blinded - Receiving Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ampicillin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Richness of the Preterm Infant Microbiome | 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. | 2 weeks |
| Shannon Diversity of the Preterm Infant Microbiome | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Lung Disease of Infancy (CLD) | Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation | 4-12 weeks |
| Necrotizing Enterocolitis (NEC) | 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). |
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Inclusion Criteria for antibiotic randomization:
Infant must be born between the gestational ages of 28 0/7 weeks and 34 6/7 weeks
-AND-
Infant must be born at investigator's home institution.
-AND-
Infant must be considered to have a low risk of infection by one of the following criteria:
Exclusion Criteria for antibiotic randomization:
Signs of clinical illness within the first 3 hours of life:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center - Comer Children's Hospital | Chicago | Illinois | 60637 | United States |
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Patients in the study were enrolled from The University of Chicago Comer Children's Hospital, a level IV NICU in Chicago, Illinois, as well as Northshore University HealthSystem Evanston Hospital, a level III NICU in Evanston, Illinois from 2015-2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2018 | Jun 15, 2020 |
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| Gentamicins | Drug | 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. |
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| Placebo | Drug | Normal saline will be given as placebo for those in the placebo comparator group. |
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| 4-12 weeks |
| Retinopathy of Prematurity (ROP) | Cases of ROP as diagnosed by the pediatric ophthalmologist | 4-12 weeks |
| Intraventricular Hemorrhage (IVH) | Cases of IVH present on any head ultrasound obtained during patient's hospitalization | 4-12 weeks |
| Death | 18 months |
| FG001 | 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. Placebo: Normal saline will be given as placebo for those in the placebo comparator group. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. Gentamicin: 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. |
| BG001 | 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. Placebo: Normal saline will be given as placebo for those in the placebo comparator group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Richness of the Preterm Infant Microbiome | 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. | Posted | Mean | Standard Deviation | 16S rRNA gene amplicon sequence variants | 2 weeks |
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| Primary | Shannon Diversity of the Preterm Infant Microbiome | 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. | Posted | Mean | Standard Deviation | Shannon diversity | 2 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Chronic Lung Disease of Infancy (CLD) | Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation | Posted | Count of Participants | Participants | 4-12 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Necrotizing Enterocolitis (NEC) | 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). | Posted | Count of Participants | Participants | 4-12 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Retinopathy of Prematurity (ROP) | Cases of ROP as diagnosed by the pediatric ophthalmologist | Posted | Count of Participants | Participants | 4-12 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Intraventricular Hemorrhage (IVH) | Cases of IVH present on any head ultrasound obtained during patient's hospitalization | Posted | Count of Participants | Participants | 4-12 weeks |
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| Secondary | Death | Posted | Count of Participants | Participants | 18 months |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. Gentamicin: 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | 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. Placebo: Normal saline will be given as placebo for those in the placebo comparator group. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina S. Kim | Neonatology, Department of Pediatrics, University of Chicago | 773-702-6210 | christinakim13@gmail.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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