Status:
NOT_YET_RECRUITING
Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
Chiesi USA, Inc.
Conditions:
Respiratory Distress Syndrome (Neonatal)
Surfactant
Eligibility:
All Genders
33-38 years
Phase:
NA
Brief Summary
The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see...
Eligibility Criteria
Inclusion
- Newborns 33-38+6 weeks gestation at birth
- ≤ 6 hours old
- Respiratory Distress: \[Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25\]
- Clinical decision for non-invasive respiratory support
- Written parental consent
Exclusion
- Surrogate deliveries
- Major congenital or chromosomal anomalies
- Prior intubation or receipt of surfactant
- Known or suspected hypoxic ischemic encephalopathy (HIE)
- Known or suspected neuromuscular disorder
- Unanticipated survival
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2031
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT07176117
Start Date
October 1 2025
End Date
June 30 2031
Last Update
September 16 2025
Active Locations (3)
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1
Sharp Chula Vista Medical Center
Chula Vista, California, United States, 91911
2
Sharp Grossmont Hospital
La Mesa, California, United States, 91942
3
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123