Premature Birth of NewbornNCT02477423
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
A study testing Ampicillin and Gentamicins in people with Premature Birth of Newborn and Enterocolitis, Necrotizing, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Premature Birth of Newborn, Enterocolitis, Necrotizing
- What is being tested?
- Ampicillin and Gentamicins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center - Comer Children's Hospital
Chicago, Illinois, 60637
About this study
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.
- Being tested
- Ampicillin, Gentamicins, Placebo
- Keywords
- Microbiome, Antibiotics
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpicillinDrug
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.
GentamicinsDrug
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.
PlaceboDrug
Normal saline will be given as placebo for those in the placebo comparator group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ampicillin; Drug: Gentamicins |
| 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (5)
Chronic Lung Disease of Infancy (CLD)
Premature infants who require > 21% FiO2 for at least 28 days and/or at 36 weeks corrected gestation
Measured: 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).
Measured: 4-12 weeks
Retinopathy of Prematurity (ROP)
Cases of ROP as diagnosed by the pediatric ophthalmologist
Measured: 4-12 weeks
Intraventricular Hemorrhage (IVH)
Cases of IVH present on any head ultrasound obtained during patient's hospitalization
Measured: 4-12 weeks
Death
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477423
- Sponsor's protocol ID
- IRB15-0053
- Status last verified
- Sep 2020
- First submitted
- 16 Jun 2015
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
- ClinicalTrials.gov ID
- NCT02477423
- Acronym / sponsor ID
- IRB15-0053
- Keywords
- Microbiome, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized & Blinded - Receiving Antibiotics | Active comparator | Drug: Ampicillin, Drug: GentamicinsThe 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 | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmpicillinAmpicillin 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 | Randomized & Blinded - Receiving Antibiotics |
| GentamicinsGentamicin 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 | Randomized & Blinded - Receiving Antibiotics |
| PlaceboNormal saline will be given as placebo for those in the placebo comparator group. | Drug | Randomized & Blinded - Receiving Placebo |
Primary outcome
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.
5 secondary outcomes
Chronic Lung Disease of Infancy (CLD)
Time frame: 4-12 weeks
Necrotizing Enterocolitis (NEC)
Time frame: 4-12 weeks
Retinopathy of Prematurity (ROP)
Time frame: 4-12 weeks
Intraventricular Hemorrhage (IVH)
Time frame: 4-12 weeks
Death
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ampicillin and Gentamicins in people with Premature Birth of Newborn and Enterocolitis, Necrotizing, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richness of the Preterm Infant Microbiome (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.