Who is sponsoring NCT04199364?

NCT04199364 is sponsored by Virgilio Paolo Carnielli.

What drugs are being tested in NCT04199364?

Interventions in NCT04199364: Poractant Alfa 80 mg/mL Intratracheal Suspension.

What condition does NCT04199364 study?

NCT04199364 studies Respiratory Distress Syndrome.

Is NCT04199364 still recruiting?

NCT04199364 is currently status unknown. Last updated 19 April 2021.

Last reviewed 2021-04-19 · How we verify

NCT04199364

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Medium vs Low Oxygen Threshold for the Surfactant Administration

Status unknown Phase 4 Last updated 19 April 2021

What this trial tests

Phase 4 trial testing Poractant Alfa 80 mg/mL Intratracheal Suspension in Respiratory Distress Syndrome in 200 participants. Status unknown.

Timeline

1 June 2021

Primary endpoint
1 July 2024

30 April 2025

Quick facts

Lead sponsor	Virgilio Paolo Carnielli
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 June 2021
Primary completion	1 July 2024
Estimated completion	30 April 2025

Drugs / interventions tested

Poractant Alfa 80 mg/mL Intratracheal Suspension — full drug profile →

Conditions studied

Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →

Sponsor

Virgilio Paolo Carnielli — full company profile →

Who can join

Adults 24 Weeks to 32 Weeks, any sex, with Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT07437391 — Effect of L-Carnitine Supplementation in Preterm Neonates · NA · recruiting
NCT06807983 — LUng and Cardiac Ultrasound for REspiratory Distress in ElDerly · NA · recruiting
NCT07154134 — Endocan and Copeptin Serum Levels in Preterm Neonates With Respiratory Distress Syndrome · recruiting
NCT06684379 — Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of A · Phase 1, PHASE2 · recruiting
NCT06430554 — Personalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability · recruiting

Other Virgilio Paolo Carnielli trials

Trials by the same sponsor.

NCT04073173 — Stress Assessment With and Without Analgesia During Surfactant Therapy in Preterm Infants. · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04199364 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Virgilio Paolo Carnielli
Last refreshed: 19 April 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04199364.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing