Who is sponsoring NCT04862377?

NCT04862377 is sponsored by Hospital Clinic of Barcelona.

What drugs are being tested in NCT04862377?

Interventions in NCT04862377: Poractant Alfa Intratracheal Suspension [Curosurf], Budesonide 0.5 MG/ML.

What condition does NCT04862377 study?

NCT04862377 studies Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant, Prematurity.

Is NCT04862377 still recruiting?

NCT04862377 is currently status unknown. Last updated 13 September 2021.

Last reviewed 2021-09-13 · How we verify

NCT04862377: BuS

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

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

Status unknown Phase 3 Last updated 13 September 2021

What this trial tests

Phase 3 trial testing Poractant Alfa Intratracheal Suspension [Curosurf] in Bronchopulmonary Dysplasia in 50 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
1 April 2024

1 April 2026

Quick facts

Lead sponsor	Hospital Clinic of Barcelona
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	50
Start date	1 October 2021
Primary completion	1 April 2024
Estimated completion	1 April 2026

Drugs / interventions tested

Poractant Alfa Intratracheal Suspension [Curosurf] — full drug profile →
Budesonide 0.5 MG/ML — full drug profile →

Conditions studied

Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
Respiratory Distress Syndrome in Premature Infant — all drugs for Respiratory Distress Syndrome in Premature Infant →
Prematurity — all drugs for Prematurity →

Sponsor

Hospital Clinic of Barcelona

Who can join

Under 48 Hours, any sex, with Bronchopulmonary Dysplasia or Respiratory Distress Syndrome in Premature Infant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Pharmacotherapy in Bronchopulmonary Dysplasia: What Is the Evidence?
Sakaria RP, Dhanireddy R. · · 2022 · cited 17× · PMID 35356441 · DOI 10.3389/fped.2022.820259

Verify or expand the search:

Other trials of Poractant Alfa Intratracheal Suspension [Curosurf]

Trials testing the same drug.

NCT04825197 — Late Surfactant After a Recruitment Maneuver in Extremely Low Gestational Age Newborns - LATE-REC-SURF Trial · Phase 2 · unknown

Other recruiting trials for Bronchopulmonary Dysplasia

Currently open trials in the same condition.

NCT06589245 — Inhaled Ciclesonide Study in Preterm Infants · Phase 1 · recruiting
NCT06512935 — Ventilator Pressure and Optimization of Compliance and Hemodynamics · NA · recruiting
NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
NCT06808997 — Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preter · recruiting
NCT06897839 — Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) · Phase 2, PHASE3 · recruiting

Other Hospital Clinic of Barcelona trials

Trials by the same sponsor.

NCT07509814 — Extended Versus Short Prehabilitation Programme for Patients With Advanced Ovarian Cancer Undergoing Major Surgery · NA · not yet recruiting
NCT07469358 — iCBT for Adolescents Obsessive-compulsive Dissorder · NA · active not recruiting
NCT07358611 — Non-invasive Mapping-Guided Atrial Fibrillation Ablation · NA · recruiting
NCT07237867 — Frequency-Dependent Effects of Percutaneous Femoral Nerve Stimulation on Quadriceps Strength in Athletes With Patellar T · NA · recruiting
NCT07163936 — Analysis of the Influence of Dialysis Fluid Composition on Vascular Calcification in Patients With Chronic Kidney Diseas · NA · not yet recruiting

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 NCT04862377 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital Clinic of Barcelona
Last refreshed: 13 September 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/NCT04862377.

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