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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
146
Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual 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.
Neonatal intensive care unit at Shands children's hospital at the Univeristy of Florida
Gainesville, Florida, United States
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
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
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
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
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
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
Days to Reach Full Feeds
Full feeds is defined as 120 milliliters per kilogram per day
Time frame: baseline to approximately 42 days
Hours Receiving Parenteral Nutrition
The number of hours participants required parenteral nutriton
Time frame: Baseline to 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hours of Central Line Access
The number of hours participants required central line access
Time frame: Baseline to 42 days
Highest Alkaline Phosphatase Level
Highest level during the first 42 days
Time frame: baseline to 42 days
Occurrence of Cholestasis
Occurrence of cholestatsis defined as a direct bilirubin level \> 2 mg/dL
Time frame: Baseline to 42 days
Level of Direct Bilirubin
Level of direct bilirubin on routine weekly or biweekly laboratory testing
Time frame: Baseline to 42 days. highest value reported
Length of Hospital Stay
Days infant remains in hospital
Time frame: baseline to approximately 3 months
Episodes of Late Onset Sepsis
Episodes of presumed or culture positive sepsis at \> 3 days of life
Time frame: 4 to 42 days
Episodes of Necrotizing Enterocolitis
Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater)
Time frame: Baseline to 42 days
Episodes of Ventilator Associated Pneumonia
Episodes of ventilator associated pneumonia
Time frame: baseline to 42 days
Episodes of Aspiration Pneumonia
Episodes of aspiration pneumonia on radiograph
Time frame: baseline to 42 days
Episodes of a Positive Tracheal Culture
Episodes of a tracheal culture positive for bacteria
Time frame: Baseline to 42 days
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
Episodes of Bronchopulmonary Dysplasia
Episodes of bronchopulmonary dysplasia
Time frame: Baseline to approximately 3 months
Highest Tracheal Pepsin Level
The highest level of pepsin obtained from endotracheal tube secretions
Time frame: Baseline to 42 days
Days of Invasive Ventilation
Number of days infants required invasive ventilation
Time frame: Baseline to approximately 3 months
Number of Infants Who Died
Number of infants who died during the 6 weeks study.
Time frame: Baseline to 42 days
Number of Abdominal Radiographs
number of abdominal radiographs performed
Time frame: baseline to 42 days
Episodes of Abdominal Distension
Episodes of increased abdominal girth by 2cm or greater
Time frame: Baseline to 42 days
Emesis
Number of emesis episodes
Time frame: baseline to 42 days
Weight
Weight at 6 weeks of age. Note infants were born weighing \< 1500 grams
Time frame: 42 days
Head Circumference
Head circumference at 42 days
Time frame: 42 days
Length
Length at 42 days
Time frame: 42 days
Presence of Blood in Stools
Proportion of guaiac positive stools.
Time frame: baseline to 42 days
Level of Fecal Calprotectin
Level of calprotectin in stools
Time frame: 42 days
Serum Gastrin Level
level of gastrin at 3 weeks
Time frame: baseline to 21 days
Serum Motilin Level
Serum motilin level at 21 days
Time frame: baseline to 21 days
Fecal S100A12
Level of fecal S100A12
Time frame: 42 days