Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change on systolic pressure of pulmonary artery |
Measured by echocardiography in millimeters of mercury (mm/Hg) |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. |
|
Primary |
Preductal partial pressure of carbon (PaCO2) |
Good response if the carbon in blood is <60-70 mmHg measured by gasometry in arterial blood |
Before surgery (baseline), 24 hour, 48 hour, 72 hour and day 7 post-surgery. |
|
Primary |
Change in Preductal and postductal oxygen saturation (SatO2) |
It is a measure of oxygenation in hemoglobin. It is preductal if the measurement id on hand, and postductal if it is on foot, determined by an pulse oximeter in percentage |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. |
|
Primary |
Inspired fraction of oxygen (FiO2) |
Oxygen concentration supplied by ventilation support in percentage |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. |
|
Primary |
Growth velocity and Nutritional status |
Measurement of body weight in grams, length, and head circumference in centimeters (if clinical condition allows it) to obtain grams/kg/d, cm/week, Z score, and eutrophic or undernutrition outcome using the Fenton's standard reference of growth and/or World Health Organization as appropriate for preterm or term infants, respectively. |
Before surgery (baseline), day 7, day 14 and day 21 post-surgery. |
|
Primary |
Pain manifestation |
Pain will be measured with the COMFORT scale computed by eight sections with scores from 1 to 5 each. |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. |
|
Secondary |
Concentration of plasma cytokines as inflammatory markers |
Determination of pro and anti-inflammatory cytokines interleukin (IL)-1beta, tumoral necrosis factor-alpha, IL-6, IL-8, IL-10, IL-12 (p70) (pg/milliliter) in plasma by luminex-based immunoassay. |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery. |
|
Secondary |
Concentration of inflammatory derived-lipid mediators |
Determination lipid mediators such as eicosanoids and resolvin(s) in ng/ml by liquid chromatography coupled to mass spectrometry. |
Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery. |
|
Secondary |
Concentration of total free thiols |
This will be measured in urine by ELISA in pg/milliliter |
At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. |
|
Secondary |
Concentration of nitrotyrosine |
This will be measured in urine by ELISA in micromol per liter (uM) |
At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. |
|
Secondary |
Concentration of the nuclear factor erythroid 2-related factor 2 (Nrf2) |
This will be measured in urine by ELISA in pg/milliliter |
At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. |
|
Secondary |
Concentration of Ratio of F2-isoprostanes (F2-isop) and F2-isofurans (F2-isof) |
This ratio will be measured in urine in nmol/liter by Liquid chromatography coupled to mass spectrometry. |
At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. |
|
Secondary |
Chronic Lung Disease |
It will be evaluated with the need of supplementary Oxygen and/or medication to improve lung function |
At hospital discharge or 56 day-old, at 6 months and one year of age |
|