None listed
Conditions
Brief summary
A significant number of late preterm and term newborns require respiratory support and surfactant administration in the immediate newborn period for respiratory distress. Although there are many methods for delivery of surfactant, almost all require laryngoscopy. For those infants born outside a hospital with a neonatal intensive care nursery this requires emergency transport and mother-baby separation as the skill of laryngoscopy is mostly held in tertiary care centres. A supraglottic airway device (SAD) is recommended by the American Academy of Pediatrics as an alternative to direct laryngoscopy in later preterm and term newborns requiring resuscitation. It is particularly useful in non-tertiary settings where the skill of laryngoscopy is not available. It is the purpose of this study in late preterm and term newborns with respiratory distress, to determine if this approach is non-inferior in therapeutic effect, presents less risk to the infant and is more user friendly than standard approaches requiring laryngoscopy. If proven effective and safe, the ease of use of a SAD in this population would mean that it could be widely applied in non-tertiary special care nurseries, reducing the need for emergency transfer to a tertiary NICU – reducing costs and keeping mothers and babies together.
Interventions
Supraglottic Airway Group
200mg/kg (2.5ml/kg) poractant alfa (Curosurf ®) surfactant administered via delivery tube following insertion of i-gel® supraglottic airway device.
The intervention will be delivered by either a Consultant Neonatologist, Neonatal Nurse Practitioner or a trainee Neonatal Registrar with the required clinical experience and expertise to undertake the task.
The i-gel is indicated for use in securing and maintaining a patent airway in routine and emergency anaesthetics. It
Supraglottic Airway Group 200mg/kg (2.5ml/kg) poractant alfa (Curosurf ®) surfactant administered via delivery tube following insertion of i-gel® supraglottic airway device. The intervention will be delivered by either a Consultant Neonatologist, Neonatal Nurse Practitioner or a trainee Neonatal Registrar with the required clinical experience and expertise to undertake the task. The i-gel is indicated for use in securing and maintaining a patent airway in routine and emergency anaesthetics. It provides a non-inflatable, anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and has been recommended as an alternative to direct laryngoscopy and endotracheal intubation in newborn infants by the American Academy of Pediatrics. The i-gel will remain in position after surfactant administration until the newborn infants is clinically stable. This vary between infants from 1-5 minutes.
Sponsors
Women's and Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
Infants are eligible for inclusion in the study if: • They are born at >33 weeks GA by best obstetric estimate and have a birth weight of >1500g; and • They are <24 hours old at the time of randomisation; and • They require nasal continuous positive airway pressure (nCPAP) after admission for moderate-to-severe respiratory distress, hypoxia or hypercapnia where the treating clinician has determined surfactant therapy is indicated and it is felt unlikely ongoing mechanical ventilation is required.
Exclusion criteria
Infants are excluded from the trial if: • They have a known major congenital abnormality that may impact on the infants’ condition (including complex congenital cardiac disease, upper airway obstruction or complex airway abnormality, gastro-intestinal malformation; and • They have previously been intubated (including intubation for suctioning below the cords in the delivery suite), or immediately need intubation, as a determined by the attending clinician.
Outcome results
None listed