Clinical trial NCT06606444: Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates with Respiratory Distress Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Hanoi Medical University
name: Hanoi Obstetrics and Gynecology Hospital
name: Göteborg University
First posted: 2024-09-23
Enrollment: 25
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Successful LMA placement, with signs of adequate airway, allowing two attempts.
timeFrame: During procedure. 0-30 minutes.
Secondary outcomes:
measure: Confirmation of carbon dioxide on carbon dioxide detector
timeFrame: During procedure. 0-30 minutes.
measure: Chest rise during LMA placement
timeFrame: During procedure 0-30 minutes.
measure: Bilateral breath sounds by auscultation during LMA placement
timeFrame: During procedure. 0-30 minutes.
measure: Number of attempts required for successful placement
timeFrame: During procedure. 0-30 minutes.
measure: Attempt duration more than 30 seconds
timeFrame: During procedure. 0-30 minutes.
measure: Duration of each LMA placement attempt
timeFrame: During procedure. 0-30 minutes.
measure: Time between attempts
timeFrame: During procedure. 0-30 minutes.
measure: Fluctuations in heart rate during placement
timeFrame: During procedure. 0-30 minutes.
measure: Fluctuations in oxygen saturation (SpO2) during placement
timeFrame: During procedure. 0-30 minutes.
measure: Fluctuations in heart rate during surfactant administration
timeFrame: During procedure. 0-30 minutes.
measure: Fluctuations in oxygen saturation (SpO2) during surfactant administration
timeFrame: During procedure. 0-30 minutes.
measure: Duration of SpO2 less than 80%
timeFrame: During procedure. 0-30 minutes.
measure: Duration of SpO2 less than 60%
timeFrame: During procedure. 0-30 minutes.
measure: Duration of SpO2 less than 40%
timeFrame: During procedure. 0-30 minutes.
measure: Duration of heart rate less than 100 beats per minute (bpm)
timeFrame: During procedure. 0-30 minutes.
measure: Duration of heart rate less than 60 beats per minute (bpm)
timeFrame: During procedure. 0-30 minutes.
measure: Number of bradycardia less than 60 bpm for more than 10 seconds
timeFrame: During procedure. 0-30 minutes.
measure: Number of desaturations to less 80% for more than 30 seconds
timeFrame: During procedure. 0-30 minutes.
measure: Number of apneas lasting more than 20 seconds
timeFrame: During procedure. 0-30 minutes.
measure: Volume of surfactant in gastric residuals after the procedure
timeFrame: During procedure. 0-30 minutes.
measure: Total procedure duration
timeFrame: During procedure. 0-30 minutes.
measure: Duration of positive pressure ventilation during LMA placement
timeFrame: During procedure. 0-30 minutes.
measure: Duration of positive pressure ventilation during surfactant administration
timeFrame: During procedure. 0-30 minutes.
measure: Duration of positive pressure ventilation during procedure
timeFrame: During procedure. 0-30 minutes.
measure: Fraction of inspired oxygen
timeFrame: 10 minutes before procedure until 1 hour after procedure.
measure: Need for early redosing of surfactant
timeFrame: Within 6 hours from first surfactant administration
measure: Need for invasive mechanical ventilation within 72 hours
timeFrame: Within 72 hours after surfactant administration
measure: Death
timeFrame: Within 7 days after birth
measure: Duration of oxygen requirement after surfactant administration
timeFrame: Within 7 days after birth
measure: Duration of continuous positive airway pressure (CPAP) after surfactant administration
timeFrame: Within 7 days after birth
measure: Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration
timeFrame: Within 7 days after birth
measure: Duration of invasive mechanical ventilation after surfactant administration
timeFrame: Within 7 days after birth
measure: Number of surfactant doses given
timeFrame: Within 7 days after birth
measure: Need for subsequent intubation and mechanical ventilation
timeFrame: Within 7 days after birth
measure: Administration method for subsequent surfactant doses
timeFrame: Within 7 days after birth
Other outcomes:
measure: Feasibility of obtaining neonatal pain score during and after procedure.
timeFrame: During procedure. 0-30 minutes.
measure: Quality of assessment of variables in pain score
timeFrame: During procedure. 0-30 minutes.
measure: Neonatal pain scale: The Premature Infant Pain Profile-Revised (PIPP-R)
timeFrame: Before, during and after procedure. 0-30 minutes.
Locations:
city: Hanoi
country: Vietnam
facility: Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
Study officials:
affiliation: Karolinska Institutet
name: Tobias Alfvén, Professor, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.