Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome

NCT06606444 | Completed

• 2 other identifiers: 2090 CN/PS2018-02770
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market. The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth. The main objectives of the study are to:

• Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
• Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
• Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
• Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews. Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Successful LMA placement, with signs of adequate airway, allowing two attempts.

  Categorical variable (Yes/No) A successful placement attempt is defined as insertion of the LMA into the infant's mouth with signs of adequate airway, as per judgement of the physician performing the procedure. Factors that will be considered are carbon dioxide (CO2)-detection, chest movement, pulmonary auscultation of bilateral breath sounds, oxygen saturation and heart rate.

  During procedure. 0-30 minutes.

Secondary Outcomes (35)

• Confirmation of carbon dioxide on carbon dioxide detector

  During procedure. 0-30 minutes.

• Chest rise during LMA placement

  During procedure 0-30 minutes.

• Bilateral breath sounds by auscultation during LMA placement

  During procedure. 0-30 minutes.

• Number of attempts required for successful placement

  During procedure. 0-30 minutes.

• Attempt duration more than 30 seconds

  During procedure. 0-30 minutes.

Other Outcomes (3)

• Feasibility of obtaining neonatal pain score during and after procedure.

  During procedure. 0-30 minutes.

• Quality of assessment of variables in pain score

  During procedure. 0-30 minutes.

• Neonatal pain scale: The Premature Infant Pain Profile-Revised (PIPP-R)

  Before, during and after procedure. 0-30 minutes.

Study Arms (1)

Surfactant administered via laryngeal mask airway

EXPERIMENTAL

Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway.

Device: Surfactant Administration Through Laryngeal or Supraglottic Airways

Interventions

Surfactant Administration Through Laryngeal or Supraglottic Airways DEVICE

While the child is spontaneously breathing on nasal CPAP treatment, the neonatal intensive care (NICU) physician will place the LMA and assess for adequate airway by CO2-detection, chest movement, pulmonary auscultation of bilateral breath sounds, gastric insufflation, oxygen saturation and heart rate. A placement attempt should not last more than 30 seconds. Surfactant will be administered slowly in 1-2 ml aliquots (Curosurf 200 mg/kg) via an appropriate size laryngeal mask airway. The neonate should primarily be spontaneously breathing and if needed receives gentle supportive positive pressure ventilation (PPV). Gentle supportive PPV is given for 30 seconds after surfactant is administered, before LMA is removed.

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 administered via laryngeal mask airway

Eligibility Criteria

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

You may qualify if:

• Parental informed consent, AND
• Inborn neonate (=born in the hospital), AND
• Gestational age less than 34 + 0 weeks, AND
• Age less than 48 hours, AND
• Birth weight from 750g to 1500g, AND
• Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.

You may not qualify if:

• Severe respiratory insufficiency in need of emergency intubation
• Previous surfactant administration
• Previous mechanical ventilation
• Known pneumothorax
• Major malformations
• Investigators not available

Sponsors & Collaborators

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

Study Sites (1)

Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital

Hanoi, 118000, Vietnam

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Respiratory Distress Syndrome

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Child Health

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 23, 2024
• Study Start: September 20, 2024
• Primary Completion: July 13, 2025
• Study Completion: August 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

VN (1)