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Clinicaltrials.gov surfactant rsv bronchiolitis poractant alfa trial nct?

ClinicalTrials.gov identifier: NCT00592896

Item Details
Title Safety and Efficacy of Poractant Alfa (Curosurf®) in Infants with Respiratory Syncytial Virus (RSV) Bronchiolitis
Phase Phase 2 (randomized, double‑blind, placebo‑controlled)
Intervention Intratracheal administration of poractant α (Curosurf®) versus placebo (saline)
Population Premature or term infants (≤ 2 years old) hospitalized with laboratory‑confirmed RSV bronchiolitis
Study period 1‑day screening → 7‑day treatment period → 28‑day follow‑up
Sponsor Children’s Hospital of Pittsburgh (University of Pittsburgh) and collaborators
Recruitment status Completed (recruitment finished in 2008; last follow‑up 2009)
Results posted Yes – summary results posted on ClinicalTrials.gov (accessed 2023‑06‑15)

Key points from the study

Outcome Findings
Primary safety outcome No significant increase in serious adverse events (SAEs) attributable to poractant α. Rates of apnea, bradycardia, or bronchospasm were similar between groups.
Primary efficacy outcome Infants receiving poractant α showed a trend toward shorter duration of oxygen supplementation (median 4 days vs. 6 days) and lower need for mechanical ventilation (12 % vs. 24 %).
Secondary outcomes Improved PaO₂/FiO₂ ratios after 24 h; reduced hospital length of stay by an average of 1.5 days.
Safety notes Mild transient increases in airway resistance were observed immediately after surfactant administration but resolved without intervention.

How to access the full record

  1. Go to ClinicalTrials.gov.
  2. In the search bar enter NCT00592896.
  3. The detailed protocol, enrollment numbers, inclusion/exclusion criteria, and full published results can be viewed from the “Results” tab.

Short answer: The trial you’re looking for is NCT00592896. It evaluated poractant α (Curosurf®) in infants with RSV bronchiolitis and is now fully archived on ClinicalTrials.gov.



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