Trial Outcomes & Findings for Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination (NCT NCT03728608)
NCT ID: NCT03728608
Last Updated: 2025-02-03
Results Overview
prepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
151 participants
Primary outcome timeframe
24 hours
Results posted on
2025-02-03
Participant Flow
Participant milestones
| Measure |
Group 1--Short Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
75
|
|
Overall Study
COMPLETED
|
58
|
62
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optimal Feeding Tube Dwell Time in VLBW Infants to Reduce Feeding Tube Contamination
Baseline characteristics by cohort
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
76 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.8 weeks gestation
STANDARD_DEVIATION 2.19 • n=5 Participants
|
27.3 weeks gestation
STANDARD_DEVIATION 2.2 • n=7 Participants
|
27.5 weeks gestation
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
75 participants
n=7 Participants
|
151 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursprepared solution of sectioned feeding tubes will be plated on Agar. After 24 hrs of incubation, unique colony types will be counted.
Outcome measures
| Measure |
Group 1--Short Dwell
n=58 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=62 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Amount of Contamination
|
357,000,000 Colony forming units
Standard Deviation 136,000,000
|
4,820,000,000 Colony forming units
Standard Deviation 1,860,000,000
|
SECONDARY outcome
Timeframe: 4 weeksThe samples will be analyzed for inflammatory markers using S100A12. Values will be log10 transformed
Outcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Gastrointestinal Inflammation - S100A12
|
0.87 log10 mg/dL
Interval 0.72 to 1.01
|
0.98 log10 mg/dL
Interval 0.94 to 1.12
|
SECONDARY outcome
Timeframe: 4 weeksThe samples will be analyzed for inflammatory markers using calprotectin immunoassays. Levels will be log10 transformed
Outcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Gastrointestinal Inflammation - Calprotectin
|
2.6 log10 mg/dL
Interval 2.5 to 2.7
|
2.6 log10 mg/dL
Interval 2.5 to 2.7
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Hours of Parenteral Nutrition
|
195.5 hours
Interval 165.5 to 230.8
|
196.4 hours
Interval 163.1 to 236.6
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Days With a Central Venous Line
|
236.7 days
Interval 191.0 to 293.2
|
248.3 days
Interval 193.3 to 318.8
|
SECONDARY outcome
Timeframe: birth until discharge from the neonatal intensive care unitOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Length of Neonatal Intensive Care Stay
|
75.6 days
Interval 70.0 to 81.7
|
75.8 days
Interval 69.1 to 83.1
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Days to Reach Full Feeds
|
9.3 days
Interval 8.5 to 10.1
|
9.4 days
Interval 8.4 to 10.5
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Number of Infants With Necrotizing Enterocolitis
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Number of Infants With Late Onset Sepsis
|
19 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Episodes of Abdominal Distension
|
21 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
Group 1--Short Dwell
n=76 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 Participants
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Number of Infants With a Direct Bilirubin > 2 mg/dL
|
5 Participants
|
5 Participants
|
Adverse Events
Group 1--Short Dwell
Serious events: 21 serious events
Other events: 0 other events
Deaths: 7 deaths
Group 2--Long Dwell
Serious events: 22 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Group 1--Short Dwell
n=76 participants at risk
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 0-48 hours for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 48 hours: Feeding tube dwell time of 48 hours for first 4 weeks of life.
|
Group 2--Long Dwell
n=75 participants at risk
Premature VLBW (very low birth weight) male and female infants will be randomly assigned to have their feeding tubes removed at 7 days for the first 4 weeks of life.The feeding tube lumen, interluminal liquid and hub will be analyzed for level of contamination.
Feeding tube dwell time of 7 day: Feeding tube dwell time of 7 days for first 4 weeks of life.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal surgery
|
2.6%
2/76 • 4 weeks
|
2.7%
2/75 • 4 weeks
|
|
Gastrointestinal disorders
necrotizing enterocolitits
|
5.3%
4/76 • 4 weeks
|
8.0%
6/75 • 4 weeks
|
|
Infections and infestations
Late onset sepsis
|
25.0%
19/76 • 4 weeks
|
28.0%
21/75 • 4 weeks
|
|
Gastrointestinal disorders
abdominal distension
|
27.6%
21/76 • 4 weeks
|
29.3%
22/75 • 4 weeks
|
|
Gastrointestinal disorders
direct bilirubin greater than 2 mg/dl
|
6.6%
5/76 • 4 weeks
|
6.7%
5/75 • 4 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place