Trial Outcomes & Findings for Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes (NCT NCT01106209)
NCT ID: NCT01106209
Last Updated: 2025-03-18
Results Overview
The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.
Recruitment status
TERMINATED
Target enrollment
14 participants
Primary outcome timeframe
60 days
Results posted on
2025-03-18
Participant Flow
No infants required surgery during the first year of life, therefore no participants were evaluated in the surgical cohort
Participant milestones
| Measure |
Prematurely Born Infants in the NICU
Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤1500 grams or \<30 weeks gestational age at birth
|
Healthy Term Infants
Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery
|
Infants Having Surgery at <1 Year Old
Infants who require surgery within their first year of life for NEC
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
3
|
0
|
|
Overall Study
COMPLETED
|
11
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes
Baseline characteristics by cohort
| Measure |
Prematurely Born Infants in the NICU
n=11 Participants
Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤1500 grams or \<30 weeks gestational age at birth
|
Healthy Term Infants
n=3 Participants
Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery
|
Subset: Enrolled Preterm Infants Having Surgery at <1 Year Old
Enrolled preterm infants who require surgery within their first year of life
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
1 Day
n=5 Participants
|
1 Day
n=7 Participants
|
—
|
1 Day
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
—
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: No study participants required surgery during the first year of life.
The objective is to characterize the time to maturation of NET formation capability in polymorphonuclear leukocytes(PMNs)isolated from newborn infants.
Outcome measures
| Measure |
Prematurely Born Infants in the NICU
n=11 Participants
Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤1500 grams or \<30 weeks gestational age at birth
|
Healthy Term Infants
n=3 Participants
Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery
|
Infants Having Surgery at <1 Year Old
Infants admitted to the PCMC same-day surgery unit in preparation for elective surgery within the first year of life
|
|---|---|---|---|
|
Time to Maturation of Neutrophil Extracellular Trap(NET) Formation
|
14 Days
Interval 3.0 to 17.0
|
5 Days
Interval 4.0 to 14.0
|
—
|
Adverse Events
Prematurely Born Infants in the NICU
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Healthy Term Infants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infants Having Surgery at <1 Year Old
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place