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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR014019-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine aspiration of gastric contents | Active Comparator | 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 | Experimental | Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No aspiration of gastric contents | Procedure | Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enteral Intake on Day of Life 7 | The volume in mL/kg of feeds provided to infant on day of life 7 | Day of life 7 |
| Enteral Intake on Day of Life 14 | The volume in mL/kg of feeds provided to infant on day of life 7 | Day of life 14 |
| Enteral Intake on Day of Life 21 | The volume in mL/kg of feeds provided to infants on day of life 21 | Day of life 21 |
| Enteral Intake on Day of Life 28 | The volume in mL/kg of feeds provided to the infant on day of life 28 | Day of life 28 |
| Enteral Intake at Day of Life 35 | The volume in mL/kg of feeds provided to infants on day of life 35 | Day of life 35 |
| Enteral Intake on Day of Life 42 | The volume in mL/kg of feeds provided to infants on day of life 42 | Day of life 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Days to Reach Full Feeds | Full feeds is defined as 120 milliliters per kilogram per day | baseline to approximately 42 days |
| Hours Receiving Parenteral Nutrition | The number of hours participants required parenteral nutriton |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie A Parker, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida | Gainesville | Florida | 32504 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31757473 | Derived | Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Aspiration and Evaluation of Gastric Residuals on Intestinal Inflammation, Bleeding, and Gastrointestinal Peptide Level. J Pediatr. 2020 Feb;217:165-171.e2. doi: 10.1016/j.jpeds.2019.10.036. Epub 2019 Nov 19. | |
| 31034045 | Derived | Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Gastric Residual Evaluation on Enteral Intake in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):534-543. doi: 10.1001/jamapediatrics.2019.0800. |
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No participants were excluded before assignment to groups
Recruitment occurred between 10/17/2013 and 10/8/2016 in a Level 4 neonatal intensive care unit
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enteral Intake on Day of Life 7 | The volume in mL/kg of feeds provided to infant on day of life 7 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 7 |
|
42 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| necrotizing enterocolits or spontaneous intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Parker | University of Florida | 352 215 9360 | parkela@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol, statistical analysis and ICF | Mar 4, 2016 | Dec 22, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Routine aspiration of gastric contents | Procedure | Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. |
|
| Baseline to 42 days |
| Hours of Central Line Access | The number of hours participants required central line access | Baseline to 42 days |
| Highest Alkaline Phosphatase Level | Highest level during the first 42 days | baseline to 42 days |
| Occurrence of Cholestasis | Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL | Baseline to 42 days |
| Level of Direct Bilirubin | Level of direct bilirubin on routine weekly or biweekly laboratory testing | Baseline to 42 days. highest value reported |
| Length of Hospital Stay | Days infant remains in hospital | baseline to approximately 3 months |
| Episodes of Late Onset Sepsis | Episodes of presumed or culture positive sepsis at > 3 days of life | 4 to 42 days |
| Episodes of Necrotizing Enterocolitis | Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater) | Baseline to 42 days |
| Episodes of Ventilator Associated Pneumonia | Episodes of ventilator associated pneumonia | baseline to 42 days |
| Episodes of Aspiration Pneumonia | Episodes of aspiration pneumonia on radiograph | baseline to 42 days |
| Episodes of a Positive Tracheal Culture | Episodes of a tracheal culture positive for bacteria | Baseline to 42 days |
| Episodes of 2 or More Positive Tracheal Aspirate Cultures | Episodes of 2 or more tracheal cultures positive for bacteria | Baseline to 42 days |
| Episodes of Bronchopulmonary Dysplasia | Episodes of bronchopulmonary dysplasia | Baseline to approximately 3 months |
| Highest Tracheal Pepsin Level | The highest level of pepsin obtained from endotracheal tube secretions | Baseline to 42 days |
| Days of Invasive Ventilation | Number of days infants required invasive ventilation | Baseline to approximately 3 months |
| Number of Infants Who Died | Number of infants who died during the 6 weeks study. | Baseline to 42 days |
| Number of Abdominal Radiographs | number of abdominal radiographs performed | baseline to 42 days |
| Episodes of Abdominal Distension | Episodes of increased abdominal girth by 2cm or greater | Baseline to 42 days |
| Emesis | Number of emesis episodes | baseline to 42 days |
| Weight | Weight at 6 weeks of age. Note infants were born weighing < 1500 grams | 42 days |
| Head Circumference | Head circumference at 42 days | 42 days |
| Length | Length at 42 days | 42 days |
| Presence of Blood in Stools | Proportion of guaiac positive stools. | baseline to 42 days |
| Level of Fecal Calprotectin | Level of calprotectin in stools | 42 days |
| Serum Gastrin Level | level of gastrin at 3 weeks | baseline to 21 days |
| Serum Motilin Level | Serum motilin level at 21 days | baseline to 21 days |
| Fecal S100A12 | Level of fecal S100A12 | 42 days |
| Adverse Event |
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| exclusion criteria found after enrollment |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Gestational age at birth | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Enteral Intake on Day of Life 14 | The volume in mL/kg of feeds provided to infant on day of life 7 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 14 |
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|
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| Primary | Enteral Intake on Day of Life 21 | The volume in mL/kg of feeds provided to infants on day of life 21 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 21 |
|
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|
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| Primary | Enteral Intake on Day of Life 28 | The volume in mL/kg of feeds provided to the infant on day of life 28 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 28 |
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|
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| Primary | Enteral Intake at Day of Life 35 | The volume in mL/kg of feeds provided to infants on day of life 35 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 35 |
|
|
|
|
| Primary | Enteral Intake on Day of Life 42 | The volume in mL/kg of feeds provided to infants on day of life 42 | Posted | Least Squares Mean | 95% Confidence Interval | mL/kg per day | Day of life 42 |
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|
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| Secondary | Days to Reach Full Feeds | Full feeds is defined as 120 milliliters per kilogram per day | Posted | Least Squares Mean | 95% Confidence Interval | days | baseline to approximately 42 days |
|
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|
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| Secondary | Hours Receiving Parenteral Nutrition | The number of hours participants required parenteral nutriton | Posted | Least Squares Mean | 95% Confidence Interval | hours | Baseline to 42 days |
|
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| Secondary | Hours of Central Line Access | The number of hours participants required central line access | Posted | Least Squares Mean | 95% Confidence Interval | Hours | Baseline to 42 days |
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| Secondary | Highest Alkaline Phosphatase Level | Highest level during the first 42 days | Posted | Median | Inter-Quartile Range | Units/Liter | baseline to 42 days |
|
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| Secondary | Occurrence of Cholestasis | Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL | Posted | Least Squares Mean | 95% Confidence Interval | Events | Baseline to 42 days |
|
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| Secondary | Level of Direct Bilirubin | Level of direct bilirubin on routine weekly or biweekly laboratory testing | Posted | Least Squares Mean | 95% Confidence Interval | mg/dl | Baseline to 42 days. highest value reported |
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| Secondary | Length of Hospital Stay | Days infant remains in hospital | Posted | Least Squares Mean | 95% Confidence Interval | days | baseline to approximately 3 months |
|
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| Secondary | Episodes of Late Onset Sepsis | Episodes of presumed or culture positive sepsis at > 3 days of life | Posted | Least Squares Mean | 95% Confidence Interval | number of episodes | 4 to 42 days |
|
|
|
|
| Secondary | Episodes of Necrotizing Enterocolitis | Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater) | Posted | Least Squares Mean | 95% Confidence Interval | number of episodes | Baseline to 42 days |
|
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| Secondary | Episodes of Ventilator Associated Pneumonia | Episodes of ventilator associated pneumonia | Posted | Number | episodes | baseline to 42 days |
|
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| Secondary | Episodes of Aspiration Pneumonia | Episodes of aspiration pneumonia on radiograph | Posted | Median | Inter-Quartile Range | episodes | baseline to 42 days |
|
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| Secondary | Episodes of a Positive Tracheal Culture | Episodes of a tracheal culture positive for bacteria | Posted | Least Squares Mean | 95% Confidence Interval | Episodes | Baseline to 42 days |
|
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| Secondary | Episodes of 2 or More Positive Tracheal Aspirate Cultures | Episodes of 2 or more tracheal cultures positive for bacteria | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 42 days |
|
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| Secondary | Episodes of Bronchopulmonary Dysplasia | Episodes of bronchopulmonary dysplasia | Posted | Least Squares Mean | 95% Confidence Interval | Episodes | Baseline to approximately 3 months |
|
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| Secondary | Highest Tracheal Pepsin Level | The highest level of pepsin obtained from endotracheal tube secretions | Posted | Median | Inter-Quartile Range | ng/ml | Baseline to 42 days |
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| Secondary | Days of Invasive Ventilation | Number of days infants required invasive ventilation | Posted | Least Squares Mean | 95% Confidence Interval | days | Baseline to approximately 3 months |
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| Secondary | Number of Infants Who Died | Number of infants who died during the 6 weeks study. | Posted | Number | participants | Baseline to 42 days |
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| Secondary | Number of Abdominal Radiographs | number of abdominal radiographs performed | Posted | Least Squares Mean | 95% Confidence Interval | number of episodes | baseline to 42 days |
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| Secondary | Episodes of Abdominal Distension | Episodes of increased abdominal girth by 2cm or greater | Posted | Least Squares Mean | 95% Confidence Interval | episodes | Baseline to 42 days |
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| Secondary | Emesis | Number of emesis episodes | Posted | Least Squares Mean | 95% Confidence Interval | episodes | baseline to 42 days |
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| Secondary | Weight | Weight at 6 weeks of age. Note infants were born weighing < 1500 grams | Posted | Least Squares Mean | 95% Confidence Interval | grams | 42 days |
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| Secondary | Head Circumference | Head circumference at 42 days | Posted | Least Squares Mean | 95% Confidence Interval | centimeters | 42 days |
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| Secondary | Length | Length at 42 days | Posted | Least Squares Mean | 95% Confidence Interval | centimeters | 42 days |
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| Secondary | Presence of Blood in Stools | Proportion of guaiac positive stools. | Posted | Least Squares Mean | 95% Confidence Interval | proportion | baseline to 42 days |
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| Secondary | Level of Fecal Calprotectin | Level of calprotectin in stools | Posted | Least Squares Mean | 95% Confidence Interval | μg/g | 42 days |
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| Secondary | Serum Gastrin Level | level of gastrin at 3 weeks | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | baseline to 21 days |
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| Secondary | Serum Motilin Level | Serum motilin level at 21 days | Posted | Least Squares Mean | 95% Confidence Interval | pg/mL | baseline to 21 days |
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| Secondary | Fecal S100A12 | Level of fecal S100A12 | Posted | Least Squares Mean | 95% Confidence Interval | ng/g | 42 days |
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| 6 |
| 74 |
| 7 |
| 74 |
| 0 |
| 74 |
| EG001 | 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. | 1 | 69 | 8 | 69 | 0 | 69 |
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| D000091642 | Urogenital Diseases |