Pharmacy and Poisons Board: Applications

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Protocol No:

ECCT/25/07/06

Date of Protocol:

27-03-2025

Study Title:	Randomized Controlled Trial of Surfactant Administered via Supraglottic Airway Device (SALSA) Compared to Endotracheal Tube (InSurE) on Survival without Mechanical Ventilation in Preterm Neonates with Respiratory Distress Syndrome in Sub-Saharan Africa
Study Objectives:	To evaluate the comparative effectiveness of surfactant administered via a supraglottic airway device (SALSA) compared to surfactant administered via endotracheal tube placed under direct laryngoscopy with rapid extubation (InSurE).
Laymans Summary:	Respiratory Distress Syndrome is the leading cause of mortality in preterm neonates globally, especially in LMICs. Evidence-based therapies for RDS include oxygen, CPAP, surfactant, and mechanical ventilation. The standard of care for preterm infants with RDS treated with CPAP therapy and oxygen is to utilize surfactant when CPAP has been optimized but an infant remains in respiratory failure. The goal of surfactant therapy is to prevent the need for mechanical ventilation or death due to respiratory failure, and it has been proven to be an effective therapy since the 1990s. In many LMICs, however, the use of surfactant is limited due to cost and availability, even though surfactant remains on the WHO’s list of essential medications. Historically, administration of surfactant has also required highly skilled providers, using techniques of direct laryngoscopy to place catheters or tubes for surfactant administration through the vocal cords of preterm infants to administer the medication directly into the lungs. Newer techniques utilizing supraglottic airway devices for surfactant administration have proven to be effective in delivering the medication to the upper airway with distribution to lungs via positive pressure breaths. However, studies on SALSA in preterm infants have been limited by available supraglottic airway device sizes. There are approximately 25 different supraglottic or laryngeal mask devices available in current clinical practice. Manufacturer’s recommendations vary, however most size 1 device are recommended for infants 2-5kg and > 34 weeks, although size 1 devices have been used in clinical trials in smaller infants. Supraglottic airway devices from one manufacturer are now available in clinical practice in size 0 and 0.5, appropriate for infants weighing < 2000 grams. Currently, the standard of care, way to give surfactant requires laryngoscopy. This is where a clinician looks directly into the baby’s airway using a laryngoscope (a metal device with light that holds the airway open) and then inserts a tube through the vocal cords, after the tube placement is checked for being in the airway or windpipe surfactant will be delivered. This method is very effective, but is challenging to learn, and may take more than one attempt even for experienced clinicians. Also, during laryngoscopy, some babies may briefly have a drop in their heart rate or oxygen levels. Supraglottic airways are a different type of device, made from a soft plastic, shaped to fit into the mouth and form a seal over the airway opening(windpipe), without passing through the vocal cords. They can be inserted without using a metal laryngoscope, they may be easier for clinicians to use and more comfortable for babies. Supraglottic airway devices are used for surfactant administration in some settings. Our study aims to compare their safety and effectiveness as compared to the above standard of care. Kenyatta National Hospital neonatal unit will participate in this proposed trial with an aim to evaluate the comparative effectiveness of surfactant administered via a supraglottic airway device (SALSA) compared to surfactant administered via endotracheal tube placed under direct laryngoscopy rapid extubation (InSurE). This will be a non-blinded randomized controlled trial.
Abstract of Study:	Each year around 15 million newborns are born prematurely and among this, 1 million die. Prematurity contributes to the leading cause of death for neonatal and under-five child mortality. The most common cause of death for preterm infants is respiratory distress syndrome (RDS). Management options for RDS include continuous positive airway positive pressure (CPAP), mechanical ventilation, and surfactant administration. Surfactant is recommended and is on the essential drug list by the World Health Organization (WHO). Though it is recommended by WHO, the cost of surfactant is not affordable for most low- or middle-income countries (LMICs). Additionally, the method of administration utilizing laryngoscopy is challenging in LMICs with limited skilled health workers. Less invasive and less technically challenging methods of surfactant administration are required to strengthen surfactant delivery. Administration via supraglottic airway device is a newer method that is both less invasive to the patient as well as less technically challenging for the health worker. The study aims to evaluate the comparative effectiveness of surfactant administered via a supraglottic airway device (SALSA) compared to surfactant administered via endotracheal tube placed under direct laryngoscopy with rapid extubation (InSurE). The design will be unblinded, multi-centre, randomized controlled trial (RCT). Te reserch question is 'Is surfactant administered via the SALSA method non-inferior (10% margin) to surfactant administered via the InSurE method for the primary outcome of survival to 72 hours without receiving or reaching criteria for mechanical ventilation?' the study population is Preterm infants (gestational age 28 0/7 -36 6/7 weeks) born in the study hospitals with birthweight ≥ 1000 grams and a clinical diagnosis of RDS who meet surfactant criteria within 24 hours from birth: Downes’ score of 4 or greater, CPAP ≥ 6 cmH20 and FiO2 ≥ 0.4 to maintain saturation 90-95% for at least 30 minutes. The study sites will be St Paul’s Hospital Millennium Medical College in Ethiopia, Kenyatta National Hospital in Kenya, and Lagos State University Teaching Hospital in Nigeria. All are government academic tertiary hospitals with neonatal intensive care units with the ability to provide CPAP with blended oxygen, surfactant and mechanical ventilation. The intervention is Surfactant administration using supraglottic airway device (SALSA) while the control will be Surfactant administration using Intubation, Surfactant administration, and Extubation (InSurE).