Effect of a Parenteral Emulsion With Omega3 on PPHN

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Hour - 15 Days
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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.
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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04031508
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Coordinación de Investigación en Salud, Mexico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mariela Bernabe-Garcia, PhD
Principal Investigator Affiliation Instituto Mexicano del Seguro Social
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Mexico
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension of Newborn, Diaphragm Defect
Study Website: View Trial Website
Additional Details

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 be performed.

Arms & Interventions

Arms

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

Interventions

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.

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International Sites

Unit of Medical Research in Nutrition, Mexico, Ciudad De Mexico, Mexico

Status

Recruiting

Address

Unit of Medical Research in Nutrition

Mexico, Ciudad De Mexico, 06720

Site Contact

Mariela Bernabe-Garcia, PhD

marielabernabe1@gmail.com

+525556276944

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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