Trial Outcomes & Findings for Aspiration of Residual Gastric Contents (NCT NCT01863043)
NCT ID: NCT01863043
Last Updated: 2023-06-28
Results Overview
The volume in mL/kg of feeds provided to infant on day of life 7
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
Day of life 7
Results posted on
2023-06-28
Participant Flow
Recruitment occurred between 10/17/2013 and 10/8/2016 in a Level 4 neonatal intensive care unit
No participants were excluded before assignment to groups
Participant milestones
| Measure |
Routine Aspiration of Gastric Contents
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
|
Overall Study
COMPLETED
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Routine Aspiration of Gastric Contents
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Overall Study
Death
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Adverse Event
|
7
|
8
|
|
Overall Study
exclusion criteria found after enrollment
|
0
|
1
|
Baseline Characteristics
Aspiration of Residual Gastric Contents
Baseline characteristics by cohort
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=72 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 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
|
27.1 weeks
STANDARD_DEVIATION 2.4 • n=5 Participants
|
27 weeks
STANDARD_DEVIATION 1.2 • n=7 Participants
|
27.03 weeks
STANDARD_DEVIATION 2.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
72 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
22 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
77 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of life 7The volume in mL/kg of feeds provided to infant on day of life 7
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake on Day of Life 7
|
27.5 mL/kg per day
Interval 21.8 to 29.5
|
22.6 mL/kg per day
Interval 18.6 to 26.5
|
PRIMARY outcome
Timeframe: Day of life 14The volume in mL/kg of feeds provided to infant on day of life 7
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake on Day of Life 14
|
83.2 mL/kg per day
Interval 72.9 to 93.8
|
94.7 mL/kg per day
Interval 84.3 to 105.2
|
PRIMARY outcome
Timeframe: Day of life 21The volume in mL/kg of feeds provided to infants on day of life 21
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake on Day of Life 21
|
109.2 mL/kg per day
Interval 98.5 to 120.0
|
117.7 mL/kg per day
Interval 106.9 to 128.5
|
PRIMARY outcome
Timeframe: Day of life 28The volume in mL/kg of feeds provided to the infant on day of life 28
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake on Day of Life 28
|
119.4 mL/kg per day
Interval 109.5 to 129.6
|
129.6 mL/kg per day
Interval 119.7 to 139.6
|
PRIMARY outcome
Timeframe: Day of life 35The volume in mL/kg of feeds provided to infants on day of life 35
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake at Day of Life 35
|
123.9 mL/kg per day
Interval 115.2 to 132.6
|
137.2 mL/kg per day
Interval 128.6 to 145.8
|
PRIMARY outcome
Timeframe: Day of life 42The volume in mL/kg of feeds provided to infants on day of life 42
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Enteral Intake on Day of Life 42
|
128.4 mL/kg per day
Interval 119.9 to 136.9
|
141.6 mL/kg per day
Interval 133.2 to 150.0
|
SECONDARY outcome
Timeframe: baseline to approximately 42 daysFull feeds is defined as 120 milliliters per kilogram per day
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Days to Reach Full Feeds
|
18.1 days
Interval 16.3 to 20.0
|
15.9 days
Interval 14.1 to 17.8
|
SECONDARY outcome
Timeframe: Baseline to 42 daysThe number of hours participants required parenteral nutriton
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Hours Receiving Parenteral Nutrition
|
358.8 hours
Interval 312.2 to 405.4
|
356.8 hours
Interval 310.6 to 403.1
|
SECONDARY outcome
Timeframe: Baseline to 42 daysThe number of hours participants required central line access
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Hours of Central Line Access
|
402.6 Hours
Interval 352.4 to 452.5
|
398.6 Hours
Interval 350.3 to 447.0
|
SECONDARY outcome
Timeframe: baseline to 42 daysHighest level during the first 42 days
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Highest Alkaline Phosphatase Level
|
451 Units/Liter
Interval 371.0 to 664.0
|
495.5 Units/Liter
Interval 393.0 to 650.5
|
SECONDARY outcome
Timeframe: Baseline to 42 daysOccurrence of cholestatsis defined as a direct bilirubin level \> 2 mg/dL
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Occurrence of Cholestasis
|
0.040 Events
Interval 0.017 to 0.092
|
0.057 Events
Interval 0.025 to 0.131
|
SECONDARY outcome
Timeframe: Baseline to 42 days. highest value reportedLevel of direct bilirubin on routine weekly or biweekly laboratory testing
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Level of Direct Bilirubin
|
0.690 mg/dl
Interval 0.568 to 0.819
|
0.671 mg/dl
Interval 0.542 to 0.799
|
SECONDARY outcome
Timeframe: baseline to approximately 3 monthsDays infant remains in hospital
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Length of Hospital Stay
|
86.4 days
Interval 80.7 to 92.1
|
79.1 days
Interval 73.17 to 84.5
|
SECONDARY outcome
Timeframe: 4 to 42 daysEpisodes of presumed or culture positive sepsis at \> 3 days of life
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Late Onset Sepsis
|
1.38 number of episodes
Interval 0.97 to 1.94
|
0.97 number of episodes
Interval 0.67 to 1.4
|
SECONDARY outcome
Timeframe: Baseline to 42 daysEpisodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Necrotizing Enterocolitis
|
0.026 number of episodes
Interval 0.006 to 0.109
|
0.008 number of episodes
Interval 0.003 to 0.046
|
SECONDARY outcome
Timeframe: baseline to 42 daysEpisodes of ventilator associated pneumonia
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Ventilator Associated Pneumonia
|
0 episodes
|
0 episodes
|
SECONDARY outcome
Timeframe: baseline to 42 daysEpisodes of aspiration pneumonia on radiograph
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Aspiration Pneumonia
|
0 episodes
Interval 0.0 to 0.0
|
0 episodes
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to 42 daysEpisodes of a tracheal culture positive for bacteria
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of a Positive Tracheal Culture
|
0.055 Episodes
Interval 0.029 to 0.107
|
0.088 Episodes
Interval 0.058 to 0.152
|
SECONDARY outcome
Timeframe: Baseline to 42 daysEpisodes of 2 or more tracheal cultures positive for bacteria
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of 2 or More Positive Tracheal Aspirate Cultures
|
0.015 episodes
Interval 0.007 to 0.033
|
0.024 episodes
Interval 0.012 to 0.047
|
SECONDARY outcome
Timeframe: Baseline to approximately 3 monthsEpisodes of bronchopulmonary dysplasia
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Bronchopulmonary Dysplasia
|
0.512 Episodes
Interval 0.305 to 0.85
|
0.680 Episodes
Interval 0.414 to 1.12
|
SECONDARY outcome
Timeframe: Baseline to 42 daysThe highest level of pepsin obtained from endotracheal tube secretions
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Highest Tracheal Pepsin Level
|
1 ng/ml
Interval 0.2 to 5.71
|
0.9 ng/ml
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline to approximately 3 monthsNumber of days infants required invasive ventilation
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Days of Invasive Ventilation
|
14.3 days
Interval 11.2 to 17.4
|
13.3 days
Interval 10.3 to 16.5
|
SECONDARY outcome
Timeframe: Baseline to 42 daysNumber of infants who died during the 6 weeks study.
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Number of Infants Who Died
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: baseline to 42 daysnumber of abdominal radiographs performed
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Number of Abdominal Radiographs
|
4.34 number of episodes
Interval 3.66 to 5.34
|
3.81 number of episodes
Interval 3.24 to 4.64
|
SECONDARY outcome
Timeframe: Baseline to 42 daysEpisodes of increased abdominal girth by 2cm or greater
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Episodes of Abdominal Distension
|
1.79 episodes
Interval 1.27 to 2.53
|
0.590 episodes
Interval 0.344 to 1.012
|
SECONDARY outcome
Timeframe: baseline to 42 daysNumber of emesis episodes
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Emesis
|
2.46 episodes
Interval 1.7 to 3.56
|
5.01 episodes
Interval 3.87 to 6.5
|
SECONDARY outcome
Timeframe: 42 daysWeight at 6 weeks of age. Note infants were born weighing \< 1500 grams
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Weight
|
1129.7 grams
Interval 1111.0 to 1148.0
|
1145 grams
Interval 1126.0 to 1164.0
|
SECONDARY outcome
Timeframe: 42 daysHead circumference at 42 days
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Head Circumference
|
25.94 centimeters
Interval 25.71 to 26.17
|
25.85 centimeters
Interval 25.62 to 26.08
|
SECONDARY outcome
Timeframe: 42 daysLength at 42 days
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Length
|
36.41 centimeters
Interval 36.08 to 36.74
|
36.78 centimeters
Interval 36.44 to 37.11
|
SECONDARY outcome
Timeframe: baseline to 42 daysProportion of guaiac positive stools.
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=74 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Presence of Blood in Stools
|
0.247 proportion
Interval 0.203 to 0.29
|
0.254 proportion
Interval 0.21 to 0.298
|
SECONDARY outcome
Timeframe: 42 daysLevel of calprotectin in stools
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=61 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=63 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Level of Fecal Calprotectin
|
557.8 μg/g
Interval 454.4 to 661.1
|
456.1 μg/g
Interval 353.7 to 558.5
|
SECONDARY outcome
Timeframe: baseline to 21 dayslevel of gastrin at 3 weeks
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=54 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=53 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Serum Gastrin Level
|
80.50 pg/mL
Interval 62.59 to 98.41
|
92.29 pg/mL
Interval 74.21 to 110.37
|
SECONDARY outcome
Timeframe: baseline to 21 daysSerum motilin level at 21 days
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=50 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=55 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Serum Motilin Level
|
228.5 pg/mL
Interval 191.8 to 265.1
|
225.8 pg/mL
Interval 180.6 to 262.1
|
SECONDARY outcome
Timeframe: 42 daysLevel of fecal S100A12
Outcome measures
| Measure |
Routine Aspiration of Gastric Contents
n=61 Participants
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=63 Participants
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Fecal S100A12
|
195.2 ng/g
Interval 119.2 to 271.0
|
144.4 ng/g
Interval 68.9 to 220.0
|
Adverse Events
Routine Aspiration of Gastric Contents
Serious events: 7 serious events
Other events: 0 other events
Deaths: 6 deaths
No Aspiration of Gastric Contents
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Routine Aspiration of Gastric Contents
n=74 participants at risk
Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
Routine aspiration of gastric contents: Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
|
No Aspiration of Gastric Contents
n=69 participants at risk
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
No aspiration of gastric contents: Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
|
|---|---|---|
|
Gastrointestinal disorders
necrotizing enterocolits or spontaneous intestinal perforation
|
9.5%
7/74 • Number of events 7 • 42 days
|
11.6%
8/69 • Number of events 8 • 42 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place