Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
Days to Reach Full Feeds |
Full feeds is defined as 120 milliliters per kilogram per day |
baseline to approximately 42 days |
|
Secondary |
Hours Receiving Parenteral Nutrition |
The number of hours participants required parenteral nutriton |
Baseline to 42 days |
|
Secondary |
Hours of Central Line Access |
The number of hours participants required central line access |
Baseline to 42 days |
|
Secondary |
Highest Alkaline Phosphatase Level |
Highest level during the first 42 days |
baseline to 42 days |
|
Secondary |
Occurrence of Cholestasis |
Occurrence of cholestatsis defined as a direct bilirubin level > 2 mg/dL |
Baseline to 42 days |
|
Secondary |
Level of Direct Bilirubin |
Level of direct bilirubin on routine weekly or biweekly laboratory testing |
Baseline to 42 days. highest value reported |
|
Secondary |
Length of Hospital Stay |
Days infant remains in hospital |
baseline to approximately 3 months |
|
Secondary |
Episodes of Late Onset Sepsis |
Episodes of presumed or culture positive sepsis at > 3 days of life |
4 to 42 days |
|
Secondary |
Episodes of Necrotizing Enterocolitis |
Episodes of radiologic evidence of necrotizing enterocolitis (Stage 2 or greater) |
Baseline to 42 days |
|
Secondary |
Episodes of Ventilator Associated Pneumonia |
Episodes of ventilator associated pneumonia |
baseline to 42 days |
|
Secondary |
Episodes of Aspiration Pneumonia |
Episodes of aspiration pneumonia on radiograph |
baseline to 42 days |
|
Secondary |
Episodes of a Positive Tracheal Culture |
Episodes of a tracheal culture positive for bacteria |
Baseline to 42 days |
|
Secondary |
Episodes of 2 or More Positive Tracheal Aspirate Cultures |
Episodes of 2 or more tracheal cultures positive for bacteria |
Baseline to 42 days |
|
Secondary |
Episodes of Bronchopulmonary Dysplasia |
Episodes of bronchopulmonary dysplasia |
Baseline to approximately 3 months |
|
Secondary |
Highest Tracheal Pepsin Level |
The highest level of pepsin obtained from endotracheal tube secretions |
Baseline to 42 days |
|
Secondary |
Days of Invasive Ventilation |
Number of days infants required invasive ventilation |
Baseline to approximately 3 months |
|
Secondary |
Number of Infants Who Died |
Number of infants who died during the 6 weeks study. |
Baseline to 42 days |
|
Secondary |
Number of Abdominal Radiographs |
number of abdominal radiographs performed |
baseline to 42 days |
|
Secondary |
Episodes of Abdominal Distension |
Episodes of increased abdominal girth by 2cm or greater |
Baseline to 42 days |
|
Secondary |
Emesis |
Number of emesis episodes |
baseline to 42 days |
|
Secondary |
Weight |
Weight at 6 weeks of age. Note infants were born weighing < 1500 grams |
42 days |
|
Secondary |
Head Circumference |
Head circumference at 42 days |
42 days |
|
Secondary |
Length |
Length at 42 days |
42 days |
|
Secondary |
Presence of Blood in Stools |
Proportion of guaiac positive stools. |
baseline to 42 days |
|
Secondary |
Level of Fecal Calprotectin |
Level of calprotectin in stools |
42 days |
|
Secondary |
Serum Gastrin Level |
level of gastrin at 3 weeks |
baseline to 21 days |
|
Secondary |
Serum Motilin Level |
Serum motilin level at 21 days |
baseline to 21 days |
|
Secondary |
Fecal S100A12 |
Level of fecal S100A12 |
42 days |
|