Aspiration of Residual Gastric Contents
- Conditions
- Nutrition, EnteralInfant, Premature
- Interventions
- Procedure: No aspiration of gastric contentsProcedure: Routine aspiration of gastric contents
- Registration Number
- NCT01863043
- Lead Sponsor
- University of Florida
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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
- Congenital or chromosomal abnormalities
- complex congenital heart diseases and congenital anatomic gastrointestinal abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No aspiration of 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. Routine aspiration of gastric contents 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.
- Primary Outcome Measures
Name Time Method 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
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 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 28 Day of life 28 The volume in mL/kg of feeds provided to the infant on day of life 28
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
- Secondary Outcome Measures
Name Time Method Episodes of Aspiration Pneumonia baseline to 42 days Episodes of aspiration pneumonia on radiograph
Episodes of Abdominal Distension Baseline to 42 days Episodes of increased abdominal girth by 2cm or greater
Head Circumference 42 days Head circumference at 42 days
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
Length of Hospital Stay baseline to approximately 3 months Days infant remains in hospital
Number of Abdominal Radiographs baseline to 42 days number of abdominal radiographs performed
Days to Reach Full Feeds baseline to approximately 42 days Full feeds is defined as 120 milliliters per kilogram per day
Highest Alkaline Phosphatase Level baseline to 42 days Highest level during the first 42 days
Level of Direct Bilirubin Baseline to 42 days. highest value reported Level of direct bilirubin on routine weekly or biweekly laboratory testing
Days of Invasive Ventilation Baseline to approximately 3 months Number of days infants required invasive ventilation
Weight 42 days Weight at 6 weeks of age. Note infants were born weighing \< 1500 grams
Occurrence of Cholestasis Baseline to 42 days Occurrence of cholestatsis defined as a direct bilirubin level \> 2 mg/dL
Episodes of Necrotizing Enterocolitis Baseline to 42 days Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Episodes of Bronchopulmonary Dysplasia Baseline to approximately 3 months Episodes of bronchopulmonary dysplasia
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
Fecal S100A12 42 days Level of fecal S100A12
Episodes of Late Onset Sepsis 4 to 42 days Episodes of presumed or culture positive sepsis at \> 3 days of life
Episodes of Ventilator Associated Pneumonia baseline to 42 days Episodes of ventilator associated pneumonia
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
Highest Tracheal Pepsin Level Baseline to 42 days The highest level of pepsin obtained from endotracheal tube secretions
Number of Infants Who Died Baseline to 42 days Number of infants who died during the 6 weeks study.
Emesis baseline to 42 days Number of emesis episodes
Serum Motilin Level baseline to 21 days Serum motilin level at 21 days
Length 42 days Length at 42 days
Trial Locations
- Locations (1)
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
🇺🇸Gainesville, Florida, United States