Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome
- Conditions
- Respiratory Distress Syndrome, Newborn
- Interventions
- Device: Surfactant Administration Through Laryngeal or Supraglottic Airways
- Registration Number
- NCT06606444
- Lead Sponsor
- Karolinska Institutet
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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%.
- Severe respiratory insufficiency in need of emergency intubation
- Previous surfactant administration
- Previous mechanical ventilation
- Known pneumothorax
- Major malformations
- Investigators not available
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surfactant administered via laryngeal mask airway Surfactant Administration Through Laryngeal or Supraglottic Airways Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway.
- Primary Outcome Measures
Name Time Method Successful LMA placement, with signs of adequate airway, allowing two attempts. During procedure. 0-30 minutes. 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.
- Secondary Outcome Measures
Name Time Method Confirmation of carbon dioxide on carbon dioxide detector During procedure. 0-30 minutes. Categorical (Yes/No)
Bilateral breath sounds by auscultation during LMA placement During procedure. 0-30 minutes. Categorical (Yes/No)
Fluctuations in heart rate during placement During procedure. 0-30 minutes. Numerical variable (beats per minute). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.
Duration of SpO2 less than 40% During procedure. 0-30 minutes. Numerical variable (seconds)
Chest rise during LMA placement During procedure 0-30 minutes. Categorical (Yes/No)
Number of attempts required for successful placement During procedure. 0-30 minutes. Numerical variable.
Attempt duration more than 30 seconds During procedure. 0-30 minutes. Categorical variable (Yes/No)
Duration of each LMA placement attempt During procedure. 0-30 minutes. Numerical variable (seconds)
Time between attempts During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of SpO2 less than 80% During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of SpO2 less than 60% During procedure. 0-30 minutes. Numerical variable (seconds)
Fluctuations in oxygen saturation (SpO2) during placement During procedure. 0-30 minutes. Numerical variable (percentage). Difference between mean/median at baseline and during placement. Measured by pulse oximetry.
Fluctuations in heart rate during surfactant administration During procedure. 0-30 minutes. Numerical variable (beats per minute). Difference between mean/median at baseline and during surfactant administration. Measured by pulse oximetry.
Fluctuations in oxygen saturation (SpO2) during surfactant administration During procedure. 0-30 minutes. Numerical variable (percentage). Difference between mean/median at baseline and during surfactant administration Measured by pulse oximetry.
Duration of heart rate less than 100 beats per minute (bpm) During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of heart rate less than 60 beats per minute (bpm) During procedure. 0-30 minutes. Numerical variable (seconds)
Volume of surfactant in gastric residuals after the procedure During procedure. 0-30 minutes. Numerical variable (milliliters)
Total procedure duration During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of positive pressure ventilation during LMA placement During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of positive pressure ventilation during surfactant administration During procedure. 0-30 minutes. Numerical variable (seconds)
Duration of positive pressure ventilation during procedure During procedure. 0-30 minutes. Numerical variable (seconds)
Fraction of inspired oxygen 10 minutes before procedure until 1 hour after procedure. 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.
Number of bradycardia less than 60 bpm for more than 10 seconds During procedure. 0-30 minutes. Numerical variable.
Number of desaturations to less 80% for more than 30 seconds During procedure. 0-30 minutes. Numerical variable.
Number of apneas lasting more than 20 seconds During procedure. 0-30 minutes. Numerical variable
Need for early redosing of surfactant Within 6 hours from first surfactant administration Categorical (Yes/No)
Need for invasive mechanical ventilation within 72 hours Within 72 hours after surfactant administration Categorical (Yes/No)
Death Within 7 days after birth Categorical (Yes/No)
Duration of oxygen requirement after surfactant administration Within 7 days after birth Numerical (hours)
Duration of continuous positive airway pressure (CPAP) after surfactant administration Within 7 days after birth Numerical variable (hours)
Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration Within 7 days after birth Numerical variable (hours)
Duration of invasive mechanical ventilation after surfactant administration Within 7 days after birth Numerical variable (hours)
Number of surfactant doses given Within 7 days after birth Numerical variable
Need for subsequent intubation and mechanical ventilation Within 7 days after birth Categorical variable (Yes/No)
Administration method for subsequent surfactant doses Within 7 days after birth Categorical. (Surfactant via laryngeal mask airway OR Surfactant via Intubation-Surfactant-Extubation OR Surfactant via intubation followed by mechanical ventilation)
Trial Locations
- Locations (1)
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
🇻🇳Hanoi, Vietnam