Comparison of brain oxygen levels in preterm newborns during three different methods of surfactant administration using a near-infrared spectroscopy device.
Not Applicable
- Conditions
- Cerebral oxygenationNeurological - Studies of the normal brain and nervous systemReproductive Health and Childbirth - Complications of newbornRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12621000944831
- Lead Sponsor
- Westmead Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 150
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)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cerebral oxygenation changes using Near Infra-red Spectroscopy (NIRS)[Continuous monitoring during surfactant delivery];Cerebral oxygenation changes using Near Infra-red Spectroscopy (NIRS)[Continual assessment over a 24 hour period immediately following surfactant delivery]
- Secondary Outcome Measures
Name Time Method Composite outcome of physiological stability as measured by heart rate (continuous ECG data), blood pressure (via indwelling arterial catheter) and hemoglobin oxygen saturation (via pulse oximetry)[Continuous monitoring will be undertaken starting 15 minutes prior to surfactant delivery until completion of surfactant delivery,];Composite outcome of physiological stability as measured by heart rate (continuous ECG data), blood pressure (via indwelling arterial catheter) and hemoglobin oxygen saturation (via pulse oximetry)[Continual monitoring over a 24 hour period immediately following surfactant delivery]