Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants (SPLASH)

Sharp HealthCare

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome (Neonatal); Surfactant

Treatments: Procedure: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA); Procedure: Continuous Positive Airway Pressure (CPAP)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07176117

SPLASH

Details and patient eligibility

About

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 if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.

Enrollment: 422 estimated patients

Sex: All

Ages: 33 to 38 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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422 participants in 2 patient groups

Prophylactic Surfactant

Experimental group

Description:

A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure).

Treatment:

Procedure: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)

Expectant Management (CPAP)

Active Comparator group

Description:

For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).

Treatment:

Procedure: Continuous Positive Airway Pressure (CPAP)