Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes
Sharp HealthCare
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 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.
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- ProcedureSurfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
- ProcedureContinuous Positive Airway Pressure (CPAP)
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Locations (3)
- Sharp Chula Vista Medical CenterChula Vista, California
- Sharp Grossmont HospitalLa Mesa, California
- Sharp Mary Birch Hospital for Women & NewbornsSan Diego, California