None listed
Conditions
Brief summary
Respiratory distress syndrome (RDS) is a condition found commonly in babies born prematurely, which results in breathing difficulty soon after birth, due to immaturity of the lungs. Many babies will be managed successfully with breathing support alone, but some require additional treatment with surfactant. Surfactant is a liquid that is applied directly into the baby’s airway, which helps open the lungs to make breathing easier Currently, the standard method to administer surfactant requires laryngoscopy. This is where a doctor looks directly into the baby’s airway using a laryngoscope (a metal device that holds the airway open) and then inserts a tube into the airway to deliver the surfactant treatment. This method is very effective, but is challenging to learn, and may take more than one attempt even for experienced doctors. 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. They can be inserted without using a metal laryngoscope, and are easier to use for doctors and more comfortable for babies. Previous research suggests that surfactant treatment can be given through a supraglottic airway, but we do not yet know if this method is as effective as using direct laryngoscopy in helping the baby’s breathing. This research study will compare the new method, supraglottic airway surfactant treatment, with the current standard method, laryngoscopy. We will measure how stable babies are during surfactant treatment, including their oxygen levels and heart rate. We will also record how many babies need a higher level of breathing support (ventilation by a breathing tube), to determine how effective the treatment is in helping babies with RDS. If supraglottic airway surfactant treatment can be used safely and effectively, and is more comfortable and easy to use, it could become the preferred method of surfactant treatment for babies with RDS.
Interventions
In the intervention group, the first dose of surfactant treatment for respiratory distress syndrome in preterm infants will be delivered by supraglottic airway device. The dose of surfactant administered will 200mg/kg and the surfactant formulation selected according to the standard in each participating centre. The supraglottic airway device (i-gel, size 1) will be inserted by a clinician trained in airway management. Correct position will be confirmed by colorimetric carbon dioxide detection.
In the intervention group, the first dose of surfactant treatment for respiratory distress syndrome in preterm infants will be delivered by supraglottic airway device. The dose of surfactant administered will 200mg/kg and the surfactant formulation selected according to the standard in each participating centre. The supraglottic airway device (i-gel, size 1) will be inserted by a clinician trained in airway management. Correct position will be confirmed by colorimetric carbon dioxide detection. Surfactant will be administered over 2-3 minutes, via a catheter inserted into the distal end of the supraglottic airway. with the total procedure expected to take approximately 5-10 minutes. Adherence to the allocated treatment method will be monitored by direct entry of procedure data into the study data capture form.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 48 Hours
Healthy volunteers
No
Inclusion criteria
Infants are eligible for inclusion in the trial if they meet all of the following criteria: - Born preterm at less than 37 weeks’ gestation - Birth weight 1250 g or above - Age less than 48 hours - Diagnosis of RDS, confirmed with chest x-ray or lung ultrasound, except where treatment is required urgently and would be delayed by imaging - Indication for surfactant treatment: required FiO2 0.30 or above to maintain target SpO2, on non-invasive respiratory support (CPAP/NIPPV or nHF), or required FiO2 >0.21 if lung ultrasound findings indicate need for surfactant
Exclusion criteria
Infants are excluded from eligibility if they meet any of the following criteria: - Previous treatment with surfactant or mechanical ventilation via an endotracheal tube - Urgent need for intubation and mechanical ventilation as determined by the treating clinician - Urgent need for surfactant prior to eligibility and consent criteria being met - Known pneumothorax - Major congenital anomaly of lungs, heart, or airway - Not receiving full active intensive care (i.e. palliative/comfort care)
Outcome results
None listed