Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorKarolinska Institutet
About this trial
Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better. It is usually given through a procedure called INSURE, where a breathing tube is placed into the baby's trachea (via an endotracheal tube) to deliver the medicine. While effective, this method is invasive and can be uncomfortable and risky for the baby.
A newer, less invasive method called SALSA uses a soft mask placed in the throat (a laryngeal mask airway) instead of an endotracheal tube to give the surfactant. This randomized controlled trial will compare SALSA to the traditional INSURE method to see if it works just as well in preventing the need for invasive breathing support within three days of treatment.
The study will include preterm babies born before 34 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found to be safe and effective, it may offer a gentler, less invasive, and easier-to-perform option for treating respiratory distress syndrome in premature babies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inborn neonate (=born in the hospital), AND
Gestational age <34+0 weeks, AND
Birth weight ≥750g, AND
Age <48 hours, AND
Disqualifiers
Severe respiratory insufficiency in need of intubation at delivery room
Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU
Previous surfactant administration
Previous invasive mechanical ventilation
Trial design
Design model
Parallel
Treatments tested in this trial
Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA)
Procedure/SurgeryWhile the infant is spontaneously breathing on nasal CPAP, the NICU physician will place the supraglottic airway device (SAD) and assess airway adequacy via CO₂ detection, chest movement, bilateral breath sounds, gastric insufflation, oxygen saturation, and heart rate. Each placement attempt should last no more than 30 seconds, with up to two attempts allowed. Surfactant (Curosurf 200 mg/kg) will be given slowly in 1-2 ml aliquots via a CE-marked preterm-sized SAD, Neo i-gel® (sizes 0.85, 0.75, 0.65; Intersurgical Ltd). The infant should primarily breathe spontaneously with PEEP from a T-piece resuscitator and receive gentle PPV if needed. PPV is continued for 30 seconds after surfactant administration before SAD removal. A reservoir bag may be used secondarily to provide PPV. If surfactant delivery via SALSA fails, the INSURE method (Intubation-Surfactant-Extubation) will be attempted.
Intubation - Surfactant administration - Extubation (INSURE)
Procedure/SurgeryStudy participants will receive surfactant therapy administered via brief endotracheal intubation - surfactant administration - and extubation (INSURE). Infants will be ventilated using a T-piece resuscitator with PEEP of 6 cm H20 and positive pressure ventilation (20 cm H20) for a couple of minutes (no more than 15 minutes) with adjustable FiO2. No mechanical ventilation will be used. Secondarily a reservoir-bag will be used for ventilation.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Surfactant therapy administered via supraglottic airway device (SALSA)Experimental treatment 1 intervention
Group B: Endotracheal intubation - surfactant administration - and extubation (INSURE)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Failure of surfactant therapy to prevent invasive mechanical ventilation
Categorical variable (Yes/No). Failure in terms of the need for endotracheal intubation and invasive mechanical ventilation. Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records. Analysis considerations: * If an infant deteriorates after randomization and requires intubation with mechanical ventilation before the allocated intervention can be performed, the case will be classified as failure in the intention-to-treat (ITT) analysis, but excluded from the per-protocol (PP) analysis. * If an infant improves after randomization and the allocated intervention is not required, the case will be included and not considered a failure in the ITT analysis, but excluded from the PP analysis.
Time frame
Within 72 hours after first surfactant administrationSecondary outcomes
1
Early failure of surfactant therapy
Categorical variable (Yes/No). Defined as use of invasive mechanical ventilation within 1 hour of first surfactant administration. Data is collected from medical record.
Time frame
Within 1 hour after first surfactant administration2
Late failure of surfactant therapy
Categorical variable (Yes/No). Defined as use of invasive mechanical ventilation. Data is collected from medical record.
Time frame
Between 1 hour and 72 hours after first surfactant administration3
Time to initiation of invasive mechanical ventilation after the procedure
Numerical variable. Elapsed time between procedure initiation and mechanical ventilation, derived from medical record timestamps.
Time frame
Before discharge (about 6-15 weeks)4
Invasive mechanical ventilation at any time during admission
Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records.
Time frame
Before discharge (about 6-15 weeks)Other outcomes
1
Adverse events
Suspected or confirmed adverse events. Reported by clinical investigators, staff or during video analysis.
Time frame
Before discharge (about 6-15 weeks)2
Pain or discomfort, measured by a neonatal pain scale
Prespecified video analysis for subsample of 50 patients per treatment arm
Time frame
During the procedure, an average of 5-10 minutes3
Duration of procedure
Numerical variable (seconds). Prespecified video analysis for subsample of 50 patients per treatment arm
Time frame
During the procedure, an average of 5-10 minutes4
Duration of desaturation of SpO2 <80%, <60% and <40% during procedure
Numerical variable (seconds). Prespecified video analysis for subsample of 50 patients per treatment arm
Time frame
During the procedure, an average of 5-10 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Göteborg University
Collaborator
University of Padova
Collaborator
Hanoi Obstetrics and Gynecology Hospital
Collaborator
Source ClinicalTrials.gov