Trial Outcomes & Findings for Antibiotic "Dysbiosis" in Preterm Infants (NCT NCT02784821)
NCT ID: NCT02784821
Last Updated: 2024-06-05
Results Overview
Enrolled subjects' medical record will be reviewed to determine the number of patients with the composite outcome and the association between antibiotic administration and the components of the composite outcome
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
Until discharge from the NICU, up to 1 year
Results posted on
2024-06-05
Participant Flow
The study protocol was approved by the University of Florida IRB in September 2016. Enrollment occurred between January 2017 and January 2019. The study was paused for a full IRB review secondary to adverse outcomes and resumed when the incident of adverse outcomes was similar to the national standard. Actual enrollment was 98 infants.
98 infants were enrolled in the study and were included in the arms of the study to receive intervention.
Participant milestones
| Measure |
Group B: Antibiotics Not Indicated
Infant not receiving antibiotics secondary to asymptomatic and delivered to mom's without high perinatal infectious risk factors.
|
Group A: Antibiotics Indicated
Infants delivered to high infectious risk mothers or infants with symptoms out of proportion to what is expected for gestational age.
|
Group CI/Randomized to Antibiotics
Infants in Group CI/antibiotics were randomized to antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
Group CII/Randomized to no Antibiotics
Group CII/no antibiotics.
Infant in group CII were randomized to no antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
32
|
28
|
27
|
|
Overall Study
COMPLETED
|
11
|
27
|
24
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
4
|
5
|
Reasons for withdrawal
| Measure |
Group B: Antibiotics Not Indicated
Infant not receiving antibiotics secondary to asymptomatic and delivered to mom's without high perinatal infectious risk factors.
|
Group A: Antibiotics Indicated
Infants delivered to high infectious risk mothers or infants with symptoms out of proportion to what is expected for gestational age.
|
Group CI/Randomized to Antibiotics
Infants in Group CI/antibiotics were randomized to antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
Group CII/Randomized to no Antibiotics
Group CII/no antibiotics.
Infant in group CII were randomized to no antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
5
|
4
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime and as part of standard of care blood tests such as complete blood cell counts, blood cultures, and C-reactive proteins will be performed.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome and inflammatory mediators will be evaluated using gastric aspirate.
Breast milk: Microbiome, and inflammatory mediators will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome, metabolome, and inflammatory mediators will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics - Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics. Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Gestational age
|
28.2 gestation age in weeks
STANDARD_DEVIATION 2.9 • n=32 Participants
|
32.1 gestation age in weeks
STANDARD_DEVIATION 1 • n=11 Participants
|
29.2 gestation age in weeks
STANDARD_DEVIATION 2.5 • n=28 Participants
|
28.8 gestation age in weeks
STANDARD_DEVIATION 2.8 • n=27 Participants
|
29.1 gestation age in weeks
STANDARD_DEVIATION 2.8 • n=98 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=32 Participants
|
7 Participants
n=11 Participants
|
15 Participants
n=28 Participants
|
10 Participants
n=27 Participants
|
48 Participants
n=98 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=32 Participants
|
4 Participants
n=11 Participants
|
13 Participants
n=28 Participants
|
17 Participants
n=27 Participants
|
50 Participants
n=98 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
11 participants
n=11 Participants
|
28 participants
n=28 Participants
|
27 participants
n=27 Participants
|
98 participants
n=98 Participants
|
|
cesarean delivery
|
19 Participants
n=32 Participants
|
3 Participants
n=11 Participants
|
17 Participants
n=28 Participants
|
19 Participants
n=27 Participants
|
58 Participants
n=98 Participants
|
|
singleton
|
24 Participants
n=32 Participants
|
10 Participants
n=11 Participants
|
20 Participants
n=28 Participants
|
21 Participants
n=27 Participants
|
75 Participants
n=98 Participants
|
|
birth weight
|
1138 grams
STANDARD_DEVIATION 446 • n=32 Participants
|
1900 grams
STANDARD_DEVIATION 417 • n=11 Participants
|
1234 grams
STANDARD_DEVIATION 424 • n=28 Participants
|
1098 grams
STANDARD_DEVIATION 384 • n=27 Participants
|
1240 grams
STANDARD_DEVIATION 479 • n=98 Participants
|
PRIMARY outcome
Timeframe: Until discharge from the NICU, up to 1 yearEnrolled subjects' medical record will be reviewed to determine the number of patients with the composite outcome and the association between antibiotic administration and the components of the composite outcome
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Number of Events of Composite Morbidities and Mortality, Including Necrotizing Enterocolitis (NEC), Late Onset Sepsis (LOS), Bronchopulmonary Dysplasia (BPD) and Death
|
19 adverse events composite outcome
|
1 adverse events composite outcome
|
9 adverse events composite outcome
|
14 adverse events composite outcome
|
SECONDARY outcome
Timeframe: Until discharge from the NICU, up to 1 yearPopulation: x2 test
Enrolled subjects' medical record will be reviewed to determine the number of patients who developed bacteremia after the first week of life (late onset sepsis) and the association between antibiotic administration and the development of late onset sepsis.
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Number of Participants With Late Onset Sepsis
|
6 participants
|
0 participants
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: Until discharge from the NICU, up to 1 yearPopulation: x2 test
Enrolled subjects' medical record will be reviewed to determine the number of patients who developed BPD and the association between antibiotic administration and diagnosis of BPD.
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
|
12 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Until discharge from the NICU, up to 1 yearPopulation: x2 test
Enrolled subjects' medical record will be reviewed to determine the number of patients who developed NEC and the association between antibiotic administration and necrotizing enterocolitis
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Number of Participants With Necrotizing Enterocolitis (NEC)
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: until discharge from the NICU, up to one year.Population: x2 test
Enrolled subjects' medical record will be reviewed to determine the number of death prior to discharge from neonatal intensive care unit
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=32 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=11 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Number of Deaths
|
5 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Average days +/- standard deviation of hospitalization, up to 15 weekslength of stay in NICU in days.
Outcome measures
| Measure |
Group A/Antibiotics Indicated
n=11 Participants
These neonates have a clinical indication to receive antibiotics, such as maternal chorioamnionitis with fetal tachycardia. The standard of care antibiotics include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Antibiotic: Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group B/Antibiotics Not Indicated
n=32 Participants
These neonates show no signs of respiratory distress(RDS) or have no indications of maternal chorioamnionitis. Antibiotics is not indicated for this group as standard of care.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
Group CI/ Randomized to Antibiotics
n=28 Participants
This group will be randomized to receive standard of care antibiotics which include Ampicillin and Gentamicin or Cefotaxime.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
Antibiotics: Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
|
Group CII/Randomized to no Antibiotics
n=27 Participants
This group will be randomized not to receive standard of care antibiotics.
Study interventions will include the collection of samples for the following: breast milk, gastric fluid and stool samples for analysis of the microbiome.
Gastric fluid: Microbiome will be evaluated using gastric aspirate.
Breast milk: Microbiome will be evaluated using mother's breast milk.
Stool samples: Microbiome will be evaluated using infant's stool.
|
|---|---|---|---|---|
|
Length of Stay.
|
26.5 days
Standard Deviation 19.7
|
64.5 days
Standard Deviation 40.5
|
53.9 days
Standard Deviation 30
|
61.6 days
Standard Deviation 40.1
|
Adverse Events
Group A: Antibiotics Indicated
Serious events: 0 serious events
Other events: 6 other events
Deaths: 5 deaths
Group B: Antibiotics Not Indicated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group CI/Randomized to Antibiotics
Serious events: 0 serious events
Other events: 5 other events
Deaths: 4 deaths
Group CII/Randomized to no Antibiotics
Serious events: 1 serious events
Other events: 4 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Group A: Antibiotics Indicated
n=32 participants at risk
Infants delivered to high infectious risk mothers or infants with symptoms out of proportion to what is expected for gestational age.
|
Group B: Antibiotics Not Indicated
n=11 participants at risk
Infant not receiving antibiotics secondary to asymptomatic and delivered to mom's without high perinatal infectious risk factors.
|
Group CI/Randomized to Antibiotics
n=28 participants at risk
Infants in Group CI/antibiotics were randomized to antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
Group CII/Randomized to no Antibiotics
n=27 participants at risk
Group CII/no antibiotics.
Infant in group CII were randomized to no antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
|---|---|---|---|---|
|
Infections and infestations
early onset sepsis
|
0.00%
0/32 • 20 months
|
0.00%
0/11 • 20 months
|
0.00%
0/28 • 20 months
|
3.7%
1/27 • 20 months
|
Other adverse events
| Measure |
Group A: Antibiotics Indicated
n=32 participants at risk
Infants delivered to high infectious risk mothers or infants with symptoms out of proportion to what is expected for gestational age.
|
Group B: Antibiotics Not Indicated
n=11 participants at risk
Infant not receiving antibiotics secondary to asymptomatic and delivered to mom's without high perinatal infectious risk factors.
|
Group CI/Randomized to Antibiotics
n=28 participants at risk
Infants in Group CI/antibiotics were randomized to antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
Group CII/Randomized to no Antibiotics
n=27 participants at risk
Group CII/no antibiotics.
Infant in group CII were randomized to no antibiotics.
Infants were eligible for randomization if they were delivered to moms with low perinatal infectious risk factor AND they had symptoms as expected for gestation.
|
|---|---|---|---|---|
|
Infections and infestations
late onset sepsis
|
18.8%
6/32 • Number of events 6 • 20 months
|
0.00%
0/11 • 20 months
|
17.9%
5/28 • Number of events 5 • 20 months
|
14.8%
4/27 • Number of events 4 • 20 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place