Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH

NCT04031508 | Enrolling By Invitation Phase 2

• 1 other identifier: R-2019-785-044
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 those who receive an emulsion containing soy oil and medium-chain triglycerides (MCT) without n-3 LC-PUFA.

Conditions

Pulmonary Hypertension of Newborn; Diaphragm Defect

Keywords

PPHN; Diaphragmatic Hernia; omega 3; DHA and EPA

Outcome Measures

Primary Outcomes (6)

• Change on systolic pressure of pulmonary artery

  Measured by echocardiography in millimeters of mercury (mm/Hg)

  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

  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

  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

  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.

  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.

  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

  Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.

• Concentration of inflammatory derived-lipid mediators

  Before surgery (baseline), 24 hour, 48 hour, 72 hour, and day 7 post-surgery.

• 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.

• 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.

• 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.

Study Arms (2)

Omega 3

EXPERIMENTAL

The experimental group will receive a parenteral emulsion containing soy oil, MCT, olive oil and n-3 LCPUFA in fish oil

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

Combination Product: lipid injectable emulsion with Fish oil

Interventions

lipid injectable emulsion with Fish oil COMBINATION_PRODUCT

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.

Also known as: SMOFLIPID

Control group; Omega 3

Eligibility Criteria

• Age: 1 Hour - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• University of Southampton: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Unit of Medical Research in Nutrition

Mexico City, Mexico City, 06720, Mexico

Location

Related Links

• experimental model report in DOI: 10.1097/CCM.0b013e31821204fb

MeSH Terms

Conditions

Hernia, Diaphragmatic

Interventions

Fish Oils; SMOFlipid

Condition Hierarchy (Ancestors)

Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Mariela Bernabe-Garcia, Ph.D.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The attendant gastroenterologist has a randomized allocation and will indicate the type of emulsion during the recruitment. Each emulsion will be designed as a code A or B. The code for each patient is stored into an opaque envelop, which is opened once the parents have given their written informed consent.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time researcher

Model Details: Use of a parenteral emulsion that is used as routine nutrition for newborns but not evaluated for persistent pulmonary hypertension.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 24, 2019
• Study Start: August 12, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)