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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-02770 | Other Identifier | Swedish Research Council |
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| Name | Class |
|---|---|
| Hanoi Medical University | OTHER |
| Hanoi Obstetrics and Gynecology Hospital | OTHER |
| Göteborg University | OTHER |
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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:
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant administered via laryngeal mask airway | Experimental | Enrolled infants will receive surfactant delivered via a neonatal size laryngeal mask airway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Alfvén, Professor, M.D, Ph.D | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital | Hanoi | 118000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38270182 | 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. |
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The datasets used and/or analysed during the current study will be available from the principal investigator on reasonable request after publication of results.
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|
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| 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 |
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. |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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