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

A Single-arm, Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates, With Respiratory Distress Syndrome, at a Level III Neonatal Intensive Care Unit in Hanoi, Vietnam

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Device: Surfactant Administration Through Laryngeal or Supraglottic Airways

Detailed Description

Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).

Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 118000
    • Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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%.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surfactant administered via laryngeal mask airway; Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway.

Device: Surfactant Administration Through Laryngeal or Supraglottic Airways; 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.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of carbon dioxide on carbon dioxide detector	Categorical (Yes/No)	During procedure. 0-30 minutes.
Chest rise during LMA placement	Categorical (Yes/No)	During procedure 0-30 minutes.
Bilateral breath sounds by auscultation during LMA placement	Categorical (Yes/No)	During procedure. 0-30 minutes.
Number of attempts required for successful placement	Numerical variable.	During procedure. 0-30 minutes.
Attempt duration more than 30 seconds	Categorical variable (Yes/No)	During procedure. 0-30 minutes.
Duration of each LMA placement attempt	Numerical variable (seconds)	During procedure. 0-30 minutes.
Time between attempts	Numerical variable (seconds)	During procedure. 0-30 minutes.
Fluctuations in heart rate during placement	Numerical variable (beats per minute). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.	During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during placement	Numerical variable (percentage). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.	During procedure. 0-30 minutes.
Fluctuations in heart rate during surfactant administration	Numerical variable (beats per minute). Difference between mean/median at baseline and during surfactant administration. Measured by pulse oximetry.	During procedure. 0-30 minutes.
Fluctuations in oxygen saturation (SpO2) during surfactant administration	Numerical variable (percentage). Difference between mean/median at baseline and during surfactant administration Measured by pulse oximetry.	During procedure. 0-30 minutes.
Duration of SpO2 less than 80%	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of SpO2 less than 60%	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of SpO2 less than 40%	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of heart rate less than 100 beats per minute (bpm)	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of heart rate less than 60 beats per minute (bpm)	Numerical variable (seconds)	During procedure. 0-30 minutes.
Number of bradycardia less than 60 bpm for more than 10 seconds	Numerical variable.	During procedure. 0-30 minutes.
Number of desaturations to less 80% for more than 30 seconds	Numerical variable.	During procedure. 0-30 minutes.
Number of apneas lasting more than 20 seconds	Numerical variable	During procedure. 0-30 minutes.
Volume of surfactant in gastric residuals after the procedure	Numerical variable (milliliters)	During procedure. 0-30 minutes.
Total procedure duration	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of positive pressure ventilation during LMA placement	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of positive pressure ventilation during surfactant administration	Numerical variable (seconds)	During procedure. 0-30 minutes.
Duration of positive pressure ventilation during procedure	Numerical variable (seconds)	During procedure. 0-30 minutes.
Fraction of inspired oxygen	Oxygen requirement to maintain SpO2 between 90-95%. Measured before start of procedure and at 5 minutes , 15 minutes , 30 minutes and 1 hour post-procedure.	10 minutes before procedure until 1 hour after procedure.
Need for early redosing of surfactant	Categorical (Yes/No)	Within 6 hours from first surfactant administration
Need for invasive mechanical ventilation within 72 hours	Categorical (Yes/No)	Within 72 hours after surfactant administration
Death	Categorical (Yes/No)	Within 7 days after birth
Duration of oxygen requirement after surfactant administration	Numerical (hours)	Within 7 days after birth
Duration of continuous positive airway pressure (CPAP) after surfactant administration	Numerical variable (hours)	Within 7 days after birth
Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration	Numerical variable (hours)	Within 7 days after birth
Duration of invasive mechanical ventilation after surfactant administration	Numerical variable (hours)	Within 7 days after birth
Number of surfactant doses given	Numerical variable	Within 7 days after birth
Need for subsequent intubation and mechanical ventilation	Categorical variable (Yes/No)	Within 7 days after birth
Administration method for subsequent surfactant doses	Categorical. (Surfactant via laryngeal mask airway OR Surfactant via Intubation-Surfactant-Extubation OR Surfactant via intubation followed by mechanical ventilation)	Within 7 days after birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of obtaining neonatal pain score during and after procedure.	Assessed by video review of expert in neonatal pain assessment	During procedure. 0-30 minutes.
Quality of assessment of variables in pain score	Assessed by video review by expert in neonatal pain assessment (eg. facial expressions, crying, breathing, pattern, leg and arm movements, and behavioral state)	During procedure. 0-30 minutes.
Neonatal pain scale: The Premature Infant Pain Profile-Revised (PIPP-R)	Assessed by video review of expert in neonatal pain assessment. Numerical variable. Indicators assessed in score: Change in heart rate from baseline (0-3p). Change in desaturation from baseline (0-3p). Brow bulge (seconds, 0-3p), Eye squeeze (seconds, 0-3p) nasolabial furrow (seconds, 0-3p), gestational age (0-3), Baseline behavioral state (0-3p. Minimum score is 0p and maximum score is 21p. Higher score indicates more pain.	Before, during and after procedure. 0-30 minutes.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Göteborg University; Hanoi Medical University; Hanoi Obstetrics and Gynecology Hospital
• Investigators: Principal Investigator: Tobias Alfvén, Professor, M.D, Ph.D, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): July 13, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: feasibility; newborn; neonate; RDS; preterm infant; respiratory distress syndrome; surfactant; laryngeal mask airway; very low birth weight; supraglottic airway device; pilot; vietnam; SALSA
• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Respiratory Tract Diseases; Disease; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Birth Weight; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 2090 CN/PS; 2018-02770 (Other Identifier: Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No