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

Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07176117

Acronym

SPLASH

Enrollment

422

Registered

2025-09-16

Start date

2025-11-20

Completion date

2031-06-30

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome (Neonatal), Surfactant

Keywords

supraglottic airway device

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 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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

33 Weeks to 38 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in Ranked Composite of Morbidities	From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.	Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.

Secondary

Measure	Time frame	Description
Length of Hospital Stay	From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.	Length of hospital stay (LOS), days.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAnup Katheria, MD

Sharp HealthCare

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026