Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam

NCT07098910 | Recruiting DMC

• 5 other identifiers: 2089 CN/PSProject-ID 2018-02770 VRRS2020-0ALFGBG-9980652-4435/2024
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better. It is usually given through a procedure called INSURE, where a breathing tube is placed into the baby's trachea (via an endotracheal tube) to deliver the medicine. While effective, this method is invasive and can be uncomfortable and risky for the baby. A newer, less invasive method called SALSA uses a soft mask placed in the throat (a laryngeal mask airway) instead of an endotracheal tube to give the surfactant. This randomized controlled trial will compare SALSA to the traditional INSURE method to see if it works just as well in preventing the need for invasive breathing support within three days of treatment. The study will include preterm babies born before 34 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found to be safe and effective, it may offer a gentler, less invasive, and easier-to-perform option for treating respiratory distress syndrome in premature babies.

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

surfactant therapy; supraglottic airway device; laryngeal mask airway; preterm infant; neonate; newborn; vietnam; SALSA; RDS; respiratory distress syndrome; very low birth weight

Outcome Measures

Primary Outcomes (1)

• Failure of surfactant therapy to prevent invasive mechanical ventilation

  Categorical variable (Yes/No). Failure in terms of the need for endotracheal intubation and invasive mechanical ventilation. Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records. Analysis considerations: * If an infant deteriorates after randomization and requires intubation with mechanical ventilation before the allocated intervention can be performed, the case will be classified as failure in the intention-to-treat (ITT) analysis, but excluded from the per-protocol (PP) analysis. * If an infant improves after randomization and the allocated intervention is not required, the case will be included and not considered a failure in the ITT analysis, but excluded from the PP analysis.

  Within 72 hours after first surfactant administration

Secondary Outcomes (36)

• Early failure of surfactant therapy

  Within 1 hour after first surfactant administration

• Late failure of surfactant therapy

  Between 1 hour and 72 hours after first surfactant administration

• Time to initiation of invasive mechanical ventilation after the procedure

  Before discharge (about 6-15 weeks)

• Invasive mechanical ventilation at any time during admission

  Before discharge (about 6-15 weeks)

• Incidence of severe bradycardia

  During the procedure, an average of 5-10 minutes

Other Outcomes (13)

• Adverse events

  Before discharge (about 6-15 weeks)

• Pain or discomfort, measured by a neonatal pain scale

  During the procedure, an average of 5-10 minutes

• Duration of procedure

  During the procedure, an average of 5-10 minutes

Study Arms (2)

Surfactant therapy administered via supraglottic airway device (SALSA)

EXPERIMENTAL

Study participants will receive surfactant therapy via a preterm size supraglottic airway device (SALSA).

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

Endotracheal intubation - surfactant administration - and extubation (INSURE)

ACTIVE COMPARATOR

Study participants will receive surfactant therapy administered via brief endotracheal intubation - surfactant administration - and extubation (INSURE).

Procedure: Intubation - Surfactant administration - Extubation (INSURE)

Interventions

Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA) PROCEDURE

While the infant is spontaneously breathing on nasal CPAP, the NICU physician will place the supraglottic airway device (SAD) and assess airway adequacy via CO₂ detection, chest movement, bilateral breath sounds, gastric insufflation, oxygen saturation, and heart rate. Each placement attempt should last no more than 30 seconds, with up to two attempts allowed. Surfactant (Curosurf 200 mg/kg) will be given slowly in 1-2 ml aliquots via a CE-marked preterm-sized SAD, Neo i-gel® (sizes 0.85, 0.75, 0.65; Intersurgical Ltd). The infant should primarily breathe spontaneously with PEEP from a T-piece resuscitator and receive gentle PPV if needed. PPV is continued for 30 seconds after surfactant administration before SAD removal. A reservoir bag may be used secondarily to provide PPV. If surfactant delivery via SALSA fails, the INSURE method (Intubation-Surfactant-Extubation) will be attempted.

Also known as: Laryngeal mask airway surfactant administration, Surfactant Therapy via Laryngeal Mask Airway, Laryngeal Mask Airway for Surfactant Administration in Neonates, Supraglottic airway devices for surfactant treatment

Surfactant therapy administered via supraglottic airway device (SALSA)

Intubation - Surfactant administration - Extubation (INSURE) PROCEDURE

Study participants will receive surfactant therapy administered via brief endotracheal intubation - surfactant administration - and extubation (INSURE). Infants will be ventilated using a T-piece resuscitator with PEEP of 6 cm H20 and positive pressure ventilation (20 cm H20) for a couple of minutes (no more than 15 minutes) with adjustable FiO2. No mechanical ventilation will be used. Secondarily a reservoir-bag will be used for ventilation.

Endotracheal intubation - surfactant administration - and extubation (INSURE)

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inborn neonate (=born in the hospital), AND
• Gestational age \<34+0 weeks, AND
• Birth weight ≥750g, AND
• Age \<48 hours, AND
• Diagnosis of RDS, confirmed with a chest x-ray or lung ultrasound, except in cases where immediate treatment is necessary and imaging would cause a delay AND
• Indication for surfactant treatment: Infant on non-invasive support (CPAP/NIPPV) and FiO2 \>0.30 to maintain oxygen saturation (SpO2) between 90% and 95%

You may not qualify if:

• Severe respiratory insufficiency in need of intubation at delivery room
• Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU
• Previous surfactant administration
• Previous invasive mechanical ventilation
• Known pneumothorax
• Major malformations
• Physician not confident with study intervention
• The physician decided not to include the patient due to a preference for performing INSURE
• Excluded due to time constraints preventing completion of informed consent and trial procedures

Sponsors & Collaborators

• Karolinska Institutet: lead
• Göteborg University: collaborator
• University of Padova: collaborator
• Hanoi Obstetrics and Gynecology Hospital: collaborator

Study Sites (1)

Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital

Hanoi, 118000, Vietnam

RECRUITING

Related Publications (3)

• Zapata HA, Fort P, Roberts KD, Kaluarachchi DC, Guthrie SO. Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA): A Viable Method for Low-Income and Middle-Income Countries. Front Pediatr. 2022 Mar 16;10:853831. doi: 10.3389/fped.2022.853831. eCollection 2022.

  PMID: 35372140 BACKGROUND

• Dempsey T, Brismar TB, Svensson-Marcial A, Blennow M, Alfven T, Hook SM, Pejovic N. Radiologic evaluation of three smaller-sized supraglottic airway device prototypes for low-birth-weight neonates. Br J Anaesth. 2025 Nov;135(5):1551-1553. doi: 10.1016/j.bja.2025.05.038. Epub 2025 Jul 3. No abstract available.

  PMID: 40610284 BACKGROUND

• Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.

  PMID: 38270182 BACKGROUND

Related Links

• Feasibility study of SALSA using the same device at the same hospital in infants with birth weigh 750-1500g

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tobias Alfvén, Professor, M.D, Ph.D

  Department of Global Public Health, Karolinska Institutet, Solna, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Alfvén, Professor, M.D, Ph.D

CONTACT

+46 70 757 80 93; tobias.alfven@ki.se

Mårten Larsson, M.D

CONTACT

+46 704 24 09 72; marten.larsson.2@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The trial statistician conducting the final analysis will be masked to intervention arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Child Health

Model Details: Investigator-initiated, single-centre, two-arm parallel-group, open-label, non-inferiority RCT with a 1:1 allocation ratio per neonate. The trial entails an internal pilot-phase of the first 100 patients.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 1, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Can be available from the principal investigator on reasonable request
• Access Criteria: Can be available from the principal investigator on reasonable request

Locations

VN (1)