Trial · NCT04031508
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
NCT04031508, Phase 2, Active not recruiting, Coordinación de Investigación en Salud, Mexico
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH. Trials, record NCT04031508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04031508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
- NCT number
- NCT04031508
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Conditions
- Pulmonary Hypertension of Newborn, Diaphragm Defect
- Interventions
- lipid injectable emulsion with Fish oil
- First posted
- 2019-07-24
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04031508
GET https://conductscience.org/api/trials/v1/NCT04031508/registered