Aspiration of Residual Gastric Contents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

Conditions
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Infant, Premature, Nutrition, Enteral

Intervention / Treatment
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* Procedure: No aspiration of gastric contents
* Procedure: Routine aspiration of gastric contents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine aspiration of gastric contents<br>Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. | Procedure: Routine aspiration of gastric contents<br>* Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.<br>|
| Experimental: No aspiration of gastric contents<br>Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents. | Procedure: No aspiration of gastric contents<br>* Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infant, Nutrition, Enteral