Trial Outcomes & Findings for Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis (NCT NCT07254559)
NCT ID: NCT07254559
Last Updated: 2026-02-17
Results Overview
Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither.
COMPLETED
144 participants
From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months old
2026-02-17
Participant Flow
Participant milestones
| Measure |
Study Cohort
Infants admitted to the NICU with very low birthweight (\<1500g).
|
|---|---|
|
Overall Study
STARTED
|
144
|
|
Overall Study
COMPLETED
|
144
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Baseline characteristics by cohort
| Measure |
Study Cohort
n=144 Participants
Infants admitted to the NICU with very low birthweight (\<1500g).
|
|---|---|
|
Age, Categorical
<=18 years
|
144 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
|
Age, Continuous
|
0 years
STANDARD_DEVIATION 0 • n=25 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=25 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=25 Participants
|
|
Gestational age
|
145 days
STANDARD_DEVIATION 22.504 • n=25 Participants
|
|
Birthweight
|
947 grams
STANDARD_DEVIATION 307.468 • n=25 Participants
|
PRIMARY outcome
Timeframe: From 3 days of age until NICU discharge, which can occur at up to 1 year of age, and on average at 3 months oldPopulation: We analyzed data on all VLBW infants admitted to the NICU in 2024.
Late-onset sepsis is defined as a positive blood culture treated with at least 5 days of antibiotics. Necrotizing enterocolitis was defined using Bell's staging criteria to include stage 2 or higher. The outcome was a binary indicator of whether either of these diagnoses was made or neither.
Outcome measures
| Measure |
Study Cohort
n=144 Participants
Infants admitted to the NICU with very low birthweight (\<1500g).
|
|---|---|
|
Number of Participants With Sepsis or Necrotizing Enterocolitis
Participants with Sepsis and/or NEC
|
20 Participants
|
|
Number of Participants With Sepsis or Necrotizing Enterocolitis
Participants without Sepsis and/or NEC
|
124 Participants
|
Adverse Events
Study Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brynne Sullivan
University of Virginia School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place