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

Study acronym: CDH-PPHN-N3
StatusEnrolling by Invitation
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jul 2025 to Nov 2026v11
  2. Primary completion date: Jul 2024 to Jul 2025
    • Study completion date: Dec 2024 to Dec 2026
    v10
  3. Trial status: Active, Not Recruiting to Enrolling by Invitation
    • Enrollment target: 30 to 40
    v9
  4. Primary endpoints revised (6)v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 30
    • Study description shortened, about 6 words
    • Site details revised
  5. Primary endpoints revised (6)v7 Show 4 more changesShow less
    • Study completion date: Jul 2024 to Dec 2024
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 2 words
    • Study title expanded, about 4 words
Show 5 earlier versionsHide 5 earlier versions
  1. Primary endpoints: 9 to 6
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 6
    • Study description shortened, about 13 words
    v6
  2. Phase: Not applicable to Phase 2v5 Show 6 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Primary and study completion dates: Jul 2022 to Jul 2024
    • Interventions: Parenteral emulsion (Dietary Supplement) to lipid injectable emulsion with Fish oil (Combination Product)
    • Eligibility criteria shortened, about 6 words
    • Site details revised
    • Collaborators expanded, about 8 words
  3. Phase: Phase 2 to Not applicablev4
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2019 to Aug 12, 2019
    • Secondary endpoints revised (7)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04031508
Lead Sponsor Coordinación de Investigación en Salud, Mexico
Collaborators: University of Southampton, Universidad Nacional Autonoma de Mexico
Conditions
(from sponsor)		 Pulmonary Hypertension of Newborn, Diaphragm Defect
Related terms Hernia, Diaphragmatic
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov