Trial · NCT04031508
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change on systolic pressure of pulmonary artery | Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. | Measured by echocardiography in millimeters of mercury (mm/Hg) |
| Primary | Preductal partial pressure of carbon (PaCO2) | Before surgery (baseline), 24 hour, 48 hour, 72 hour and day 7 post-surgery. | Good response if the carbon in blood is \<60-70 mmHg measured by gasometry in arterial blood |
| Primary | Change in Preductal and postductal oxygen saturation (SatO2) | Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. | 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 |
| Primary | Inspired fraction of oxygen (FiO2) | Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. | Oxygen concentration supplied by ventilation support in percentage |
| Primary | Growth velocity and Nutritional status | Before surgery (baseline), day 7, day 14 and day 21 post-surgery. | 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. |
| Primary | Pain manifestation | Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery. | Pain will be measured with the COMFORT scale computed by eight sections with scores from 1 to 5 each. |
| Secondary | Concentration of plasma cytokines as inflammatory markers | Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery. | 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. |
| Secondary | Concentration of inflammatory derived-lipid mediators | Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery. | Determination lipid mediators such as eicosanoids and resolvin(s) in ng/ml by liquid chromatography coupled to mass spectrometry. |
| Secondary | Concentration of total free thiols | At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. | This will be measured in urine by ELISA in pg/milliliter |
| Secondary | Concentration of nitrotyrosine | At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. | This will be measured in urine by ELISA in micromol per liter (uM) |
| Secondary | Concentration of the nuclear factor erythroid 2-related factor 2 (Nrf2) | At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. | This will be measured in urine by ELISA in pg/milliliter |
| Secondary | Concentration of Ratio of F2-isoprostanes (F2-isop) and F2-isofurans (F2-isof) | At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery. | This ratio will be measured in urine in nmol/liter by Liquid chromatography coupled to mass spectrometry. |
| Secondary | Chronic Lung Disease | At hospital discharge or 56 day-old, at 6 months and one year of age | It will be evaluated with the need of supplementary Oxygen and/or medication to improve lung function |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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