Infant, Premature, Nutrition, Enteral
Conditions
Keywords
Premature Infant, Nutrition, Enteral
Brief summary
The primary purpose of this study is to determine nutrition outcomes and risks to gastrointestinal integrity and function of aspirating for routine gastric contents prior to each feeding in very low birth weight premature infants.
Detailed description
The participants in the study will be randomly assigned (like the flip of a coin) to either have the leftover food in their stomach removed before each feeding, or not have the leftover food removed before each feeding. In addition, when a blood drawn is performed as regular care an extra amount with be taken. A test to determine how much of the hormones gastrin and motilin are contained in the blood will be performed. Stool samples will be collected. Participation could last up to approximately 6 to 8 weeks of age.
Interventions
PROCEDURENo aspiration of gastric contents
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
PROCEDURERoutine 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.
Sponsors
National Institute of Nursing Research (NINR)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No
Inclusion criteria
* born at 32 weeks of less of gestational age * birth weight \</= to 1250 grams * receiving some enteral feedings by 72 hours of age * receiving parenteral feedings by 24 hours of age
Exclusion criteria
* Congenital or chromosomal abnormalities * complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enteral Intake on Day of Life 7 | Day of life 7 | The volume in mL/kg of feeds provided to infant on day of life 7 |
| Enteral Intake on Day of Life 14 | Day of life 14 | The volume in mL/kg of feeds provided to infant on day of life 7 |
| Enteral Intake on Day of Life 21 | Day of life 21 | The volume in mL/kg of feeds provided to infants on day of life 21 |
| Enteral Intake on Day of Life 28 | Day of life 28 | The volume in mL/kg of feeds provided to the infant on day of life 28 |
| Enteral Intake at Day of Life 35 | Day of life 35 | The volume in mL/kg of feeds provided to infants on day of life 35 |
| Enteral Intake on Day of Life 42 | Day of life 42 | The volume in mL/kg of feeds provided to infants on day of life 42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | baseline to approximately 3 months | Days infant remains in hospital |
| Episodes of Late Onset Sepsis | 4 to 42 days | Episodes of presumed or culture positive sepsis at \> 3 days of life |
| Episodes of Necrotizing Enterocolitis | Baseline to 42 days | Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater) |
| Episodes of Ventilator Associated Pneumonia | baseline to 42 days | Episodes of ventilator associated pneumonia |
| Episodes of Aspiration Pneumonia | baseline to 42 days | Episodes of aspiration pneumonia on radiograph |
| Episodes of a Positive Tracheal Culture | Baseline to 42 days | Episodes of a tracheal culture positive for bacteria |
| Episodes of 2 or More Positive Tracheal Aspirate Cultures | Baseline to 42 days | Episodes of 2 or more tracheal cultures positive for bacteria |
| Episodes of Bronchopulmonary Dysplasia | Baseline to approximately 3 months | Episodes of bronchopulmonary dysplasia |
| Highest Tracheal Pepsin Level | Baseline to 42 days | The highest level of pepsin obtained from endotracheal tube secretions |
| Days of Invasive Ventilation | Baseline to approximately 3 months | Number of days infants required invasive ventilation |
| Number of Infants Who Died | Baseline to 42 days | Number of infants who died during the 6 weeks study. |
| Days to Reach Full Feeds | baseline to approximately 42 days | Full feeds is defined as 120 milliliters per kilogram per day |
| Episodes of Abdominal Distension | Baseline to 42 days | Episodes of increased abdominal girth by 2cm or greater |
| Emesis | baseline to 42 days | Number of emesis episodes |
| Weight | 42 days | Weight at 6 weeks of age. Note infants were born weighing \< 1500 grams |
| Head Circumference | 42 days | Head circumference at 42 days |
| Length | 42 days | Length at 42 days |
| Presence of Blood in Stools | baseline to 42 days | Proportion of guaiac positive stools. |
| Level of Fecal Calprotectin | 42 days | Level of calprotectin in stools |
| Serum Gastrin Level | baseline to 21 days | level of gastrin at 3 weeks |
| Serum Motilin Level | baseline to 21 days | Serum motilin level at 21 days |
| Fecal S100A12 | 42 days | Level of fecal S100A12 |
| Number of Abdominal Radiographs | baseline to 42 days | number of abdominal radiographs performed |
| Hours Receiving Parenteral Nutrition | Baseline to 42 days | The number of hours participants required parenteral nutriton |
| Hours of Central Line Access | Baseline to 42 days | The number of hours participants required central line access |
| Highest Alkaline Phosphatase Level | baseline to 42 days | Highest level during the first 42 days |
| Occurrence of Cholestasis | Baseline to 42 days | Occurrence of cholestatsis defined as a direct bilirubin level \> 2 mg/dL |
| Level of Direct Bilirubin | Baseline to 42 days. highest value reported | Level of direct bilirubin on routine weekly or biweekly laboratory testing |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between 10/17/2013 and 10/8/2016 in a Level 4 neonatal intensive care unit
Pre-assignment details
No participants were excluded before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| 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. | 72 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 8 |
| Overall Study | Death | 6 | 1 |
| Overall Study | exclusion criteria found after enrollment | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Routine Aspiration of Gastric Contents | No Aspiration of Gastric Contents | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 72 Participants | 146 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 27.1 weeks STANDARD_DEVIATION 2.4 | 27 weeks STANDARD_DEVIATION 1.2 | 27.03 weeks STANDARD_DEVIATION 2.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 42 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 49 Participants | 28 Participants | 77 Participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Male | 37 Participants | 35 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 74 | 1 / 69 |
| other Total, other adverse events | 0 / 74 | 0 / 69 |
| serious Total, serious adverse events | 7 / 74 | 8 / 69 |
Outcome results
Primary
Enteral Intake at Day of Life 35
The volume in mL/kg of feeds provided to infants on day of life 35
Time frame: Day of life 35
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake at Day of Life 35 | 123.9 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake at Day of Life 35 | 137.2 mL/kg per day |
p-value: 0.03Mixed Models Analysis
Primary
Enteral Intake on Day of Life 14
The volume in mL/kg of feeds provided to infant on day of life 7
Time frame: Day of life 14
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake on Day of Life 14 | 83.2 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake on Day of Life 14 | 94.7 mL/kg per day |
p-value: 0.12Mixed Models Analysis
Primary
Enteral Intake on Day of Life 21
The volume in mL/kg of feeds provided to infants on day of life 21
Time frame: Day of life 21
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake on Day of Life 21 | 109.2 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake on Day of Life 21 | 117.7 mL/kg per day |
p-value: 0.28Mixed Models Analysis
Primary
Enteral Intake on Day of Life 28
The volume in mL/kg of feeds provided to the infant on day of life 28
Time frame: Day of life 28
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake on Day of Life 28 | 119.4 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake on Day of Life 28 | 129.6 mL/kg per day |
p-value: 0.15Mixed Models Analysis
Primary
Enteral Intake on Day of Life 42
The volume in mL/kg of feeds provided to infants on day of life 42
Time frame: Day of life 42
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake on Day of Life 42 | 128.4 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake on Day of Life 42 | 141.6 mL/kg per day |
p-value: 0.03Mixed Models Analysis
Primary
Enteral Intake on Day of Life 7
The volume in mL/kg of feeds provided to infant on day of life 7
Time frame: Day of life 7
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Enteral Intake on Day of Life 7 | 27.5 mL/kg per day |
| No Aspiration of Gastric Contents | Enteral Intake on Day of Life 7 | 22.6 mL/kg per day |
p-value: 0.27Mixed Models Analysis
Secondary
Days of Invasive Ventilation
Number of days infants required invasive ventilation
Time frame: Baseline to approximately 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Days of Invasive Ventilation | 14.3 days |
| No Aspiration of Gastric Contents | Days of Invasive Ventilation | 13.3 days |
p-value: 0.97Accelerated failure time regression mode
Secondary
Days to Reach Full Feeds
Full feeds is defined as 120 milliliters per kilogram per day
Time frame: baseline to approximately 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Days to Reach Full Feeds | 18.1 days |
| No Aspiration of Gastric Contents | Days to Reach Full Feeds | 15.9 days |
p-value: 0.59Accelerated failure time regression mode
Secondary
Emesis
Number of emesis episodes
Time frame: baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Emesis | 2.46 episodes |
| No Aspiration of Gastric Contents | Emesis | 5.01 episodes |
p-value: 0.002Mixed Models Analysis
Secondary
Episodes of 2 or More Positive Tracheal Aspirate Cultures
Episodes of 2 or more tracheal cultures positive for bacteria
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of 2 or More Positive Tracheal Aspirate Cultures | 0.015 episodes |
| No Aspiration of Gastric Contents | Episodes of 2 or More Positive Tracheal Aspirate Cultures | 0.024 episodes |
p-value: 0.17Mixed Models Analysis
Secondary
Episodes of Abdominal Distension
Episodes of increased abdominal girth by 2cm or greater
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Abdominal Distension | 1.79 episodes |
| No Aspiration of Gastric Contents | Episodes of Abdominal Distension | 0.590 episodes |
p-value: 0.001Mixed Models Analysis
Secondary
Episodes of a Positive Tracheal Culture
Episodes of a tracheal culture positive for bacteria
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of a Positive Tracheal Culture | 0.055 Episodes |
| No Aspiration of Gastric Contents | Episodes of a Positive Tracheal Culture | 0.088 Episodes |
p-value: 0.17Mixed Models Analysis
Secondary
Episodes of Aspiration Pneumonia
Episodes of aspiration pneumonia on radiograph
Time frame: baseline to 42 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Aspiration Pneumonia | 0 episodes |
| No Aspiration of Gastric Contents | Episodes of Aspiration Pneumonia | 0 episodes |
p-value: 0.27Wilcoxon (Mann-Whitney)
Secondary
Episodes of Bronchopulmonary Dysplasia
Episodes of bronchopulmonary dysplasia
Time frame: Baseline to approximately 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Bronchopulmonary Dysplasia | 0.512 Episodes |
| No Aspiration of Gastric Contents | Episodes of Bronchopulmonary Dysplasia | 0.680 Episodes |
p-value: 0.43Mixed Models Analysis
Secondary
Episodes of Late Onset Sepsis
Episodes of presumed or culture positive sepsis at \> 3 days of life
Time frame: 4 to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Late Onset Sepsis | 1.38 number of episodes |
| No Aspiration of Gastric Contents | Episodes of Late Onset Sepsis | 0.97 number of episodes |
p-value: 0.08Mixed Models Analysis
Secondary
Episodes of Necrotizing Enterocolitis
Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Necrotizing Enterocolitis | 0.026 number of episodes |
| No Aspiration of Gastric Contents | Episodes of Necrotizing Enterocolitis | 0.008 number of episodes |
p-value: 0.25Mixed Models Analysis
Secondary
Episodes of Ventilator Associated Pneumonia
Episodes of ventilator associated pneumonia
Time frame: baseline to 42 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Episodes of Ventilator Associated Pneumonia | 0 episodes |
| No Aspiration of Gastric Contents | Episodes of Ventilator Associated Pneumonia | 0 episodes |
Secondary
Fecal S100A12
Level of fecal S100A12
Time frame: 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Fecal S100A12 | 195.2 ng/g |
| No Aspiration of Gastric Contents | Fecal S100A12 | 144.4 ng/g |
p-value: 0.195Regression, Linear
Secondary
Head Circumference
Head circumference at 42 days
Time frame: 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Head Circumference | 25.94 centimeters |
| No Aspiration of Gastric Contents | Head Circumference | 25.85 centimeters |
p-value: 0.56Mixed Models Analysis
Secondary
Highest Alkaline Phosphatase Level
Highest level during the first 42 days
Time frame: baseline to 42 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Highest Alkaline Phosphatase Level | 451 Units/Liter |
| No Aspiration of Gastric Contents | Highest Alkaline Phosphatase Level | 495.5 Units/Liter |
p-value: 0.95Wilcoxon (Mann-Whitney)
Secondary
Highest Tracheal Pepsin Level
The highest level of pepsin obtained from endotracheal tube secretions
Time frame: Baseline to 42 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Highest Tracheal Pepsin Level | 1 ng/ml |
| No Aspiration of Gastric Contents | Highest Tracheal Pepsin Level | 0.9 ng/ml |
p-value: 0.694Wilcoxon (Mann-Whitney)
Secondary
Hours of Central Line Access
The number of hours participants required central line access
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Hours of Central Line Access | 402.6 Hours |
| No Aspiration of Gastric Contents | Hours of Central Line Access | 398.6 Hours |
p-value: 0.95Accelerated failure time regression mode
Secondary
Hours Receiving Parenteral Nutrition
The number of hours participants required parenteral nutriton
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Hours Receiving Parenteral Nutrition | 358.8 hours |
| No Aspiration of Gastric Contents | Hours Receiving Parenteral Nutrition | 356.8 hours |
p-value: 0.64Accelerated failure time regression mode
Secondary
Length
Length at 42 days
Time frame: 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Length | 36.41 centimeters |
| No Aspiration of Gastric Contents | Length | 36.78 centimeters |
p-value: 0.59Mixed Models Analysis
Secondary
Length of Hospital Stay
Days infant remains in hospital
Time frame: baseline to approximately 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Length of Hospital Stay | 86.4 days |
| No Aspiration of Gastric Contents | Length of Hospital Stay | 79.1 days |
p-value: 0.01Accelerated failure time regression mode
Secondary
Level of Direct Bilirubin
Level of direct bilirubin on routine weekly or biweekly laboratory testing
Time frame: Baseline to 42 days. highest value reported
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Level of Direct Bilirubin | 0.690 mg/dl |
| No Aspiration of Gastric Contents | Level of Direct Bilirubin | 0.671 mg/dl |
p-value: 0.98Mixed Models Analysis
Secondary
Level of Fecal Calprotectin
Level of calprotectin in stools
Time frame: 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Level of Fecal Calprotectin | 557.8 μg/g |
| No Aspiration of Gastric Contents | Level of Fecal Calprotectin | 456.1 μg/g |
p-value: 0.694Regression, Linear
Secondary
Number of Abdominal Radiographs
number of abdominal radiographs performed
Time frame: baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Number of Abdominal Radiographs | 4.34 number of episodes |
| No Aspiration of Gastric Contents | Number of Abdominal Radiographs | 3.81 number of episodes |
p-value: 0.25Mixed Models Analysis
Secondary
Number of Infants Who Died
Number of infants who died during the 6 weeks study.
Time frame: Baseline to 42 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Number of Infants Who Died | 6 participants |
| No Aspiration of Gastric Contents | Number of Infants Who Died | 1 participants |
p-value: 0.6Mixed Models Analysis
Secondary
Occurrence of Cholestasis
Occurrence of cholestatsis defined as a direct bilirubin level \> 2 mg/dL
Time frame: Baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Occurrence of Cholestasis | 0.040 Events |
| No Aspiration of Gastric Contents | Occurrence of Cholestasis | 0.057 Events |
p-value: 0.23Accelerated failure time regression mode
Secondary
Presence of Blood in Stools
Proportion of guaiac positive stools.
Time frame: baseline to 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Presence of Blood in Stools | 0.247 proportion |
| No Aspiration of Gastric Contents | Presence of Blood in Stools | 0.254 proportion |
p-value: 0.888Mixed Models Analysis
Secondary
Serum Gastrin Level
level of gastrin at 3 weeks
Time frame: baseline to 21 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Serum Gastrin Level | 80.50 pg/mL |
| No Aspiration of Gastric Contents | Serum Gastrin Level | 92.29 pg/mL |
p-value: 0.248general linear mixed model
Secondary
Serum Motilin Level
Serum motilin level at 21 days
Time frame: baseline to 21 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Serum Motilin Level | 228.5 pg/mL |
| No Aspiration of Gastric Contents | Serum Motilin Level | 225.8 pg/mL |
p-value: 0.694general linear mixed model
Secondary
Weight
Weight at 6 weeks of age. Note infants were born weighing \< 1500 grams
Time frame: 42 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Routine Aspiration of Gastric Contents | Weight | 1129.7 grams |
| No Aspiration of Gastric Contents | Weight | 1145 grams |
p-value: 0.03Mixed Models Analysis