Pulmonary Hypertension of NewbornPhase 2CDH-PPHN-N3NCT04031508
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
A Phase 2 study testing lipid injectable emulsion with Fish oil in people with Pulmonary Hypertension of Newborn and Diaphragm Defect, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with persistent pulmonary hypertension of the newborn (PPHN) compared with… Read more about this study
- Who is it for?
- Ages 1 hour to 15 days
- Conditions the study is for
- Pulmonary Hypertension of Newborn, Diaphragm Defect
- What is being tested?
- lipid injectable emulsion with Fish oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 12 Aug 2019to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Plan to administrate TPN for at least 7 days
- Clinical, gasometric, and echocardiographic diagnosis of congenital diaphragmatic hernia.
- Gestational age >=34 weeks.
- Written informed consent signed by both parents after an explanation of the objectives, procedures and possible risks and benefits of the research, along with the signature of two witnesses
Who cannot join
- Diagnosis of complex congenital cardiopathy
- Cyanotic congenital cardiology defect
- Insufficiency of the tricuspid valve
- Immunosuppressive disease. HIV has been associated with PPHN and human herpesvirus with vascular remodeling, perivascular macrophages, and lung fibrosis
- Clinical entities that preclude the total parenteral nutrition for one day or longer.
- Presence of profuse and persistent haemorrhage at any level
Show all 10Show fewer
- Elimination criteria
- Parents who withdraw their consent.
- Starting a drug at doses for nonclotting treatment such as heparin, enoxaparin.
- Development of profuse and persistent haemorrhage at any level after receiving vitamin K treatment.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unit of Medical Research in Nutrition
Mexico City, Mexico City, 06720
About this study
Official title: Effect of a Parenteral Emulsion With LC-PUFA Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension Associated With Congenital Diaphragmatic Hernia
The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with persistent pulmonary hypertension of the newborn (PPHN) compared with those who receive an emulsion containing soy oil and medium-chain triglycerides (MCT) without n-3 LC-PUFA.
Read the detailed description
Background. Persistent pulmonary hypertension of the newborn (PPHN), is a syndrome characterized by difficulty to provide normal pulmonary vasodilatation at birth or after birth, which may be related to right ventricular dysfunction, congenital diaphragmatic hernia, sepsis, and meconium aspiration. This condition is understudied. PPHN causes pulmonary vascular resistance (PVR) that decreases left pulmonary artery flow (LPA), meaning that blood cannot be oxygenated in the lungs, leading to low oxygen delivery to all organs. Expensive medication along with ventilator support may help, but the latter and PPHN increase the production of the inflammatory mediators such as pro-inflammatory cytokines and markers of oxidative stress, which cause cell toxicity. To treat the hernia, infants undergo corrective surgery, which further increases the production of inflammatory markers and worsens oxidative stress. As a result, the pain of the surgery also worsens the hypoxemia and respiratory insufficiency in the newborn. PPHN is associated with chronic lung disease (CLD). To date, there is no effective treatment for neonates with PPHN, and around one-third of patients may not respond to current management, leading to the death of up to 33% of infants in developed countries. In Mexico, the mortality rate from PPHN may reach 80%, which is an unacceptable outcome at a high cost. Therefore, the prevention or reduction of the severity of PPHN is actively sought.
Previous reports have shown that the n-3 long-chain polyunsaturated fatty acids (LC-PUFA), such as docosahexaenoic acid (DHA) improves the nutritional status and clinical outcomes in septic newborn reduce systemic inflammation and organ dysfunction in newborns who underwent cardiovascular surgery with a shorter stay in the neonatal intensive care unit. In addition, those babies received lower amounts of analgesics. Other authors have shown that n-3 LC-PUFA reduces oxidative stress. In experimental models of PPHN, the EPA and DHA from Omegaven (fish oil) increased pulmonary artery flow and decrease pulmonary vascular resistance. In the current project, it is hypothesized that n-3 LC-PUFA improves clinical outcomes such as decreasing pulmonary vascular pressure and markers of inflammation and oxidative stress in neonates with PPHN. This hypothesis has not been evaluated.
Objective. The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 LC-PUFA in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with PPHN compared with those who receive an emulsion containing soy and medium-chain triglycerides (MCT) without n-3 LC-PUFA.
Methodology. A double-blind clinical trial will be carried out on Mexican newborns diagnosed with PPHN. The control group will receive intravenous nutrition support including a lipid emulsion based on soy oil plus MCT (control group) and the intervention group will receive a lipid emulsion based on soy oil, MCT, olive oil, and fish oil (n-3 LC-PUFA group); both groups will receive a dose of lipid (3 g/kg/d maximum), through total parenteral nutrition (TPN) for at least 7 days.
The effect of n-3 LC-PUFA will be evaluated on:
- Clinical outcomes, nutritional status, the manifestation of pain
- Markers of inflammation
- Oxidative stress markers
To compare the groups, the Exact Fisher´s, Student's t, or U-Mann-Whitney tests will be applied as appropriate. To adjust the effect of n-3 LC-PUFA for confounders such as fatty acid background and medication, Repeated Measures ANOVA and binary logistic regression will be performed.
- Being tested
- lipid injectable emulsion with Fish oil
- Keywords
- PPHN, Diaphragmatic Hernia, omega 3, DHA and EPA
- Medical subject headings
- Hernia, Diaphragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid injectable emulsion with Fish oilCombination product
Also called SMOFLIPID
TPN will start at 1.5-2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 3.0 g/kg/d for at least 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 | Experimental | The experimental group will receive a parenteral emulsion containing soy oil, MCT, olive oil and n-3 LCPUFA in fish oil Receives: Combination Product: lipid injectable emulsion with Fish oil |
| Control group | Sham comparator | The Control group will receive a parenteral emulsion containing soy oil and MCT Receives: Combination Product: lipid injectable emulsion with Fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on systolic pressure of pulmonary artery
Measured by echocardiography in millimeters of mercury (mm/Hg)
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.
Preductal partial pressure of carbon (PaCO2)
Good response if the carbon in blood is <60-70 mmHg measured by gasometry in arterial blood
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour and day 7 post-surgery.
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
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.
Inspired fraction of oxygen (FiO2)
Oxygen concentration supplied by ventilation support in percentage
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.
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.
Measured: Before surgery (baseline), day 7, day 14 and day 21 post-surgery.
Pain manifestation
Pain will be measured with the COMFORT scale computed by eight sections with scores from 1 to 5 each.
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.
Secondary outcomes (7)
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.
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.
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.
Measured: Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.
Concentration of total free thiols
This will be measured in urine by ELISA in pg/milliliter
Measured: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Concentration of nitrotyrosine
This will be measured in urine by ELISA in micromol per liter (uM)
Measured: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Concentration of the nuclear factor erythroid 2-related factor 2 (Nrf2)
This will be measured in urine by ELISA in pg/milliliter
Measured: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
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.
Measured: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Chronic Lung Disease
It will be evaluated with the need of supplementary Oxygen and/or medication to improve lung function
Measured: At hospital discharge or 56 day-old, at 6 months and one year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start12 Aug 2019
- Primary completion1 Sep 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Use of a parenteral emulsion that is used as routine nutrition for newborns but not evaluated for persistent pulmonary hypertension.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- University of Southampton, Universidad Nacional Autonoma de Mexico, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
- Responsible party
- Principal investigator, Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico
- Investigators
- Mariela Bernabe-Garcia, Ph.D., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031508
- Sponsor's protocol ID
- R-2019-785-044
- Acronym
- CDH-PPHN-N3
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Parenteral Emulsion With LC-PUFA Omega 3 on Clinical Outcomes, Inflammatory and Oxidative Stress Markers in Neonates With Persistent Pulmonary Hypertension Associated With Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT04031508
- Acronym / sponsor ID
- CDH-PPHN-N3 / R-2019-785-044
- Keywords
- PPHN, Diaphragmatic Hernia, omega 3, DHA and EPA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- University of Southampton, Universidad Nacional Autonoma de Mexico, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 long-chain polyunsaturated fatty acids (LC-PUFA) in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with persistent pulmonary hypertension of the newborn (PPHN) compared with those who receive an emulsion containing soy oil and medium-chain triglycerides (MCT) without n-3 LC-PUFA.
Detailed description
Background. Persistent pulmonary hypertension of the newborn (PPHN), is a syndrome characterized by difficulty to provide normal pulmonary vasodilatation at birth or after birth, which may be related to right ventricular dysfunction, congenital diaphragmatic hernia, sepsis, and meconium aspiration. This condition is understudied. PPHN causes pulmonary vascular resistance (PVR) that decreases left pulmonary artery flow (LPA), meaning that blood cannot be oxygenated in the lungs, leading to low oxygen delivery to all organs. Expensive medication along with ventilator support may help, but the latter and PPHN increase the production of the inflammatory mediators such as pro-inflammatory cytokines and markers of oxidative stress, which cause cell toxicity. To treat the hernia, infants undergo corrective surgery, which further increases the production of inflammatory markers and worsens oxidative stress. As a result, the pain of the surgery also worsens the hypoxemia and respiratory insufficiency in the newborn. PPHN is associated with chronic lung disease (CLD). To date, there is no effective treatment for neonates with PPHN, and around one-third of patients may not respond to current management, leading to the death of up to 33% of infants in developed countries. In Mexico, the mortality rate from PPHN may reach 80%, which is an unacceptable outcome at a high cost. Therefore, the prevention or reduction of the severity of PPHN is actively sought.
Previous reports have shown that the n-3 long-chain polyunsaturated fatty acids (LC-PUFA), such as docosahexaenoic acid (DHA) improves the nutritional status and clinical outcomes in septic newborn reduce systemic inflammation and organ dysfunction in newborns who underwent cardiovascular surgery with a shorter stay in the neonatal intensive care unit. In addition, those babies received lower amounts of analgesics. Other authors have shown that n-3 LC-PUFA reduces oxidative stress. In experimental models of PPHN, the EPA and DHA from Omegaven (fish oil) increased pulmonary artery flow and decrease pulmonary vascular resistance. In the current project, it is hypothesized that n-3 LC-PUFA improves clinical outcomes such as decreasing pulmonary vascular pressure and markers of inflammation and oxidative stress in neonates with PPHN. This hypothesis has not been evaluated.
Objective. The purpose of this study is to evaluate the effect of a parenteral emulsion containing n-3 LC-PUFA in fish oil on clinical outcomes, markers of inflammation and oxidative stress, and pain in neonates with PPHN compared with those who receive an emulsion containing soy and medium-chain triglycerides (MCT) without n-3 LC-PUFA.
Methodology. A double-blind clinical trial will be carried out on Mexican newborns diagnosed with PPHN. The control group will receive intravenous nutrition support including a lipid emulsion based on soy oil plus MCT (control group) and the intervention group will receive a lipid emulsion based on soy oil, MCT, olive oil, and fish oil (n-3 LC-PUFA group); both groups will receive a dose of lipid (3 g/kg/d maximum), through total parenteral nutrition (TPN) for at least 7 days.
The effect of n-3 LC-PUFA will be evaluated on:
- Clinical outcomes, nutritional status, the manifestation of pain
- Markers of inflammation
- Oxidative stress markers
To compare the groups, the Exact Fisher´s, Student's t, or U-Mann-Whitney tests will be applied as appropriate. To adjust the effect of n-3 LC-PUFA for confounders such as fatty acid background and medication, Repeated Measures ANOVA and binary logistic regression will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Use of a parenteral emulsion that is used as routine nutrition for newborns but not evaluated for persistent pulmonary hypertension.
| Arm | Type | Receives |
|---|---|---|
| Omega 3 | Experimental | Combination Product: lipid injectable emulsion with Fish oilThe experimental group will receive a parenteral emulsion containing soy oil, MCT, olive oil and n-3 LCPUFA in fish oil |
| Control group | Sham comparator | Combination Product: lipid injectable emulsion with Fish oilThe Control group will receive a parenteral emulsion containing soy oil and MCT |
Who may qualify
- Ages
- 1 hour to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Plan to administrate TPN for at least 7 days
- Clinical, gasometric, and echocardiographic diagnosis of congenital diaphragmatic hernia.
- Gestational age >=34 weeks.
- Written informed consent signed by both parents after an explanation of the objectives, procedures and possible risks and benefits of the research, along with the signature of two witnesses
Key exclusion criteria (10 listed)
- Diagnosis of complex congenital cardiopathy
- Cyanotic congenital cardiology defect
- Insufficiency of the tricuspid valve
- Immunosuppressive disease. HIV has been associated with PPHN and human herpesvirus with vascular remodeling, perivascular macrophages, and lung fibrosis
- Clinical entities that preclude the total parenteral nutrition for one day or longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipid injectable emulsion with Fish oilAlso: SMOFLIPIDTPN will start at 1.5-2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 3.0 g/kg/d for at least 7 days. | Combination product | Control group, Omega 3 |
Primary outcome
Change on systolic pressure of pulmonary artery
Time frame: 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)
Preductal partial pressure of carbon (PaCO2)
Time frame: 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
Change in Preductal and postductal oxygen saturation (SatO2)
Time frame: 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
Inspired fraction of oxygen (FiO2)
Time frame: 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
Growth velocity and Nutritional status
Time frame: 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.
Pain manifestation
Time frame: 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.
7 secondary outcomes
Concentration of plasma cytokines as inflammatory markers
Time frame: Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.
Concentration of inflammatory derived-lipid mediators
Time frame: Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.
Concentration of total free thiols
Time frame: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Concentration of nitrotyrosine
Time frame: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Concentration of the nuclear factor erythroid 2-related factor 2 (Nrf2)
Time frame: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Concentration of Ratio of F2-isoprostanes (F2-isop) and F2-isofurans (F2-isof)
Time frame: At study entry, before surgery (2 baselines), and once a day until day 7 after surgery, then at 14 and 21 days-post-surgery.
Chronic Lung Disease
Time frame: At hospital discharge or 56 day-old, at 6 months and one year of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- experimental model report in DOI:10.3390/nu9070761Link provided by the sponsor.
- experimental model report in DOI: 10.1097/CCM.0b013e31821204fbLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariela Bernabe-Garcia, Ph.D. principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lipid injectable emulsion with Fish oil in people with Pulmonary Hypertension of Newborn and Diaphragm Defect, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on systolic pressure of pulmonary artery (time frame: Before surgery (baseline), 24 hour, 48 hour, 72 hour, day 7, day 14 and day 21 post-surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.