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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
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The disease, disorder, syndrome, illness, or injury that is being studied.
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 with 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 death up to 33% of the 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 the 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 in Mexican newborns diagnosed
with PPHN. 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 and a maximum of 21 days.
The effect of n-3 LC-PUFA will be evaluated on:
1. Clinical outcomes, nutritional status, perception of pain. 2. Markers of inflammation. 3. 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
Experimental: Omega 3
The experimental group will receive a parenteral emulsion containing soy oil, MCT, olive oil and n-3 LCPUFA in fish oil
Sham Comparator: Control group
The Control group will receive a parenteral emulsion containing soy oil and MCT
Combination Product: - lipid injectable emulsion with Fish oil
TPN will start at 2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 4.0 g/kg/d for at least 14 days.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Unit of Medical Research in Nutrition
Mexico, Ciudad De Mexico, 06720
Mariela Bernabe-Garcia, PhD