None listed
Conditions
Brief summary
Preterm infants develop respiratory distress syndrome (RDS) soon after birth due to immaturity and lack of surfactant. Several studies have demonstrated the effectiveness of artificial surfactant treatment in improving the outcome from RDS with reduced morbidity and improved survival. There is significant variation in clinical practice on how surfactant is administered. Traditionally, medications are administered to reduce pain prior to endotracheal intubation for surfactant administration. Several trials have demonstrated that the use of premedication for intubation of the newborn significantly improves intubating conditions, decreases the time and number of attempts needed to complete the intubation procedure, and minimizes the potential for intubation-related airway trauma. However, some centres continue to not use pain medications during this procedure as it can delay extubation and supress spontaneous breathing efforts of the baby. Recently, a minimally invasive surfactant therapy (MIST) has been reported and is used to administer surfactant. This method does not use premedications or endotracheal tube, instead it uses a very small catheter in spontaneously breathing preterm infants. There is limited knowledge on the effects of the different methods of surfactant administration on brain oxygen levels in preterm infants especially when premedications are not used. This observational study aims to compare the effects of three different methods of surfactant administration on brain oxygen levels in preterm infants born at 26 weeks gestation to 31+6 weeks of gestation. Once a specialist clinician in each participating unit determines the need to administer surfactant treatment, near-infrared spectroscopy (NIRS) monitoring will be started to collect data on brain oxygen levels for infants consented to participate in the study. Findings of this novel study will significantly improve the understanding and gaps in knowledge of the impact of different ways of administration of surfactant on stability of oxygen delivery to the brain as well as overall physiological stability of the baby. The study will aim to identify the best method for delivering surfactant to preterm babies with respiratory distress at birth.
Interventions
Upon admission to NICU, the need to administer surfactant therapy will be determined by the attending Neonatologist in three tertiary centers, each using different established protocols for surfactant administration. The same surfactant product will be used at each site.
Site 1: NICU at John Hunter hospital practices surfactant administration soon after birth.
Summary of surfactant administration: Preterm infants are receiving continuous positive airway pressure (CPAP), intubation using an end
Upon admission to NICU, the need to administer surfactant therapy will be determined by the attending Neonatologist in three tertiary centers, each using different established protocols for surfactant administration. The same surfactant product will be used at each site. Site 1: NICU at John Hunter hospital practices surfactant administration soon after birth. Summary of surfactant administration: Preterm infants are receiving continuous positive airway pressure (CPAP), intubation using an endotracheal tube occurs without premedications, surfactant is administered followed by extubation to CPAP. Site 2: NICU at Liverpool Hospital administers surfactant using MIST technique. Summary of surfactant administration: Preterm infants are receiving continuous positive airway pressure (CPAP), intubation using a small catheter (no endotracheal tube and without premedications), surfactant is administered while CPAP is being continued, followed by continuation of CPAP. In addition to standard clinical monitoring (heart rate, non -invasively monitored blood pressure, oxygen saturation), Near Infra-Red Spectroscopy (NIRS) monitoring (one probe on the left fronto-parietal region) will be commenced 15 minutes before commencing the process for delivering surfactant, continued during surfactant administration and for 24 hours after the procedure. Following this, NIRS monitoring will cease and physiological data collection will end.
Sponsors
Westmead Hospital
Eligibility
Sex/Gender
All
Age
26 Weeks to 31 Weeks
Healthy volunteers
No
Inclusion criteria
Inborn preterm infants between 26+0 weeks and 31+6 weeks gestation
Exclusion criteria
Lethal or major congenital abnormality Preterm infants with preterm prolonged rupture of membranes from less than 20 weeks in pregnancy Preterm infants receiving inotropes Preterm infants who received CPR at birth or elevated lactate of greater than 10 mMol/L Preterm infants intubated prior to admission to NICU Preterm infants with major IVH on the side of cerebral NIRS monitoring as identified on formal cranial ultrasound (Grade III or higher by Papile’s classification)
Outcome results
None listed