None listed
Conditions
Brief summary
Respiratory Distress Syndrome (RDS) in the newborn is caused mainly by a deficiency in pulmonary surfactant and is a major cause of morbidity and mortality among preterm infants. The distribution of surfactant within the lungs and the correlation with physiological responses when using it have not been previously assessed in human infants. Electrical Impedance Tomography (EIT) is a safe, non-invasive technique that can be used in preterm infants to provide valuable physiological data about regional lung aeration. Therefore, the purpose of this study is to use EIT to examine the distribution of ventilation within the lungs after surfactant administration (either a bolus via ETT or nebulised via nCPAP) and compare with a group who do not require surfactant.
Interventions
This is a non-randomised three arm study. Group 1 will consist of babies who receive AeroFactTM. Group 2 will be babies who would have met criteria for AeroFactTM treatment but who remain on nCPAP only (“usual care” controls). Group 3 will comprise babies who are on nCPAP but are deemed by their treating clinicians to need intubation and endotracheal surfactant administration. Enrolment will continue sequentially until 10 infants are recruited in group 1, then 20 infants in group 2. Meanwhile, g
This is a non-randomised three arm study. Group 1 will consist of babies who receive AeroFactTM. Group 2 will be babies who would have met criteria for AeroFactTM treatment but who remain on nCPAP only (“usual care” controls). Group 3 will comprise babies who are on nCPAP but are deemed by their treating clinicians to need intubation and endotracheal surfactant administration. Enrolment will continue sequentially until 10 infants are recruited in group 1, then 20 infants in group 2. Meanwhile, group 3 infants can be recruited at any time during the duration of the study. Lung function will be measured using electrical impedance tomography (EIT) and lung ultrasound and physiological measurements will be taken from prior to surfactant instillation and every 30 minutes until 2 hours post surfactant (or equivalent time in the CPAP only group) by the research nurse. The EIT belt will be placed around the circumference of the chest prior to surfactant instillation and remain for the 2 hour duration of the measurement period with measurements. A 3 minute EIT measurement will be taken prior to surfactant instillation, and then every 30 minutes for 2 hours.
Sponsors
Mater Health
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
0 to 72 Hours
Healthy volunteers
No
Inclusion criteria
• Infants 26 0/7 to 31 6/7 weeks corrected gestational age (gestation at birth plus days since birth) • Weight appropriate for gestational age at birth • Age < 72 hours • Currently on nCPAP with an FiO2 requirement <0.30 • Approval of treating medical and nursing staff for recruitment to relevant study arm • Parent(s) or guardian able and willing to provide informed consent • At least one parent or guardian aged 18 years or older at the time of consent • Have not yet received a dose of surfactant
Exclusion criteria
• Apgar score less than or equal to 5 at five minutes after birth • Both parents of baby under 18 years of age (due to the complexities of obtaining consent). • Prior instillation of surfactant • Congenital anomaly or syndrome expected to have significant effect on cardio-respiratory function • Other diseases interfering with cardiopulmonary functions (hydrops fetalis, toxoplasmosis, rubella, cytomegalovirus, herpes simplex) • Known or suspected chromosomal abnormality • Concomitant or expected treatment with inhaled nitric oxide • Any infant with fragile skin where EIT belt placement or TBS placement may damage the skin.
Outcome results
None listed