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Surfactant for Respiratory Distress in Late Preterm and Early Term Infants

This study is looking at ways to help infants born a little early (late preterm) or on time (early term) who have breathing problems, called Respiratory Distress Syndrome. Researchers want to see if giving a medicine called surfactant through a less invasive method, using a special device called a supraglottic airway, along with continuous positive airway pressure (CPAP), is better than CPAP alone. Surfactant helps the lungs work better. The study aims to enroll 422 infants. To join, infants must be between 33 and 38 weeks gestation, less than 6 hours old, have significant breathing difficulties, and need non-invasive breathing support. The main goal is to compare how well these treatments reduce health problems for infants from birth up to 6 months of age.

Study design
This is an interventional study comparing two treatment approaches for respiratory distress syndrome in infants. It plans to enroll 422 participants.
What's involved
Infants in the study will either receive a single dose of surfactant through a supraglottic airway device and continue on CPAP, or they will only continue on CPAP. They will be monitored from birth through hospital discharge, up to 6 months of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of birth through study completion at birth-hospital discharge, up to 6 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07176117

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

Enrolling by Invitation
NAAges 33–38InterventionalTreatment
Sharp HealthCare
~422 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)Continuous Positive Airway Pressure (CPAP)

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in Ranked Composite of Morbidities
Measured over From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Conditions

Respiratory Distress Syndrome (Neonatal)
Surfactant

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Respiratory Distress Syndrome

NCT07176117

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sharp Chula Vista Medical Center

    Chula Vista, Californiano site contact published

  • Sharp Grossmont Hospital

    La Mesa, Californiano site contact published

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anup Katheria, MD · PRINCIPAL_INVESTIGATOR · Sharp HealthCare

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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

What this trial measures

  • Difference in Ranked Composite of MorbiditiesFrom 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.