MedTrace Logo

Prophylactic Minimally Invasive Surfactant Evaluation

NCT06007547 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-07

No results posted yet for this study

Summary

The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?

Conditions

  • Respiratory Distress Syndrome, Newborn
  • Premature Birth

Interventions

DRUG

Poractant Alfa

Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter

Sponsors & Collaborators

  • Chiesi USA, Inc.

    collaborator INDUSTRY

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Matthew Derrick, MBBS · Northshore Univ Healthsystem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
15 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06007547 on ClinicalTrials.gov