None listed
Conditions
Brief summary
Both indomethacin and ibuprofen are routinely prescribed to close a patent ductus arteriosus (PDA). However the effect of each medicine on cerebral circulation, is different. These differential effects may be secondary to drug specific alterations in cerebral oxygen kinetics. We propose that in order to fully understand the effect of indomethacin and ibuprofen administration on cerebral haemodynamics, it is critical to interrogate both cerebral oxygen delivery and consumption. We hypothesise that indomethacin, in comparison to ibuprofen reduces cerebral blood flow without adversely altering cerebral oxygen kinetics in preterm newborns with a clinically significant PDA.
Interventions
This is an observational trial of cerebral oxygen kinetic and haemodynamic responses in newborn infants <30 weeks gestation following administration of indomethacin or ibuprofen for haemodynamically significant ductus arteriosus.
Treatment of a patent ductus arteriosus is a clinical decision prior to study inclusion. Once enrolled in the study newborns will receivin either ibuprofen (20mg/kg) or Indometacin (0.2mg/kg).
Babies enrolled in the trial will have a number or observations and measureme
This is an observational trial of cerebral oxygen kinetic and haemodynamic responses in newborn infants <30 weeks gestation following administration of indomethacin or ibuprofen for haemodynamically significant ductus arteriosus. Treatment of a patent ductus arteriosus is a clinical decision prior to study inclusion. Once enrolled in the study newborns will receivin either ibuprofen (20mg/kg) or Indometacin (0.2mg/kg). Babies enrolled in the trial will have a number or observations and measurements. 1.regional cerebral tissue oxygen saturation - data to be collected continuously from baseline up to 6 hours after medication infusion. Additional data will be captured for 30 miutes between 20 and 26 hours after medication administration. 2. Internal Carotid blood flow - measured by serial pulsed-wave Doppler ultrasound before, 5, 30 mins, 4-6 hours and 20-26 hours after medication administration. 3. Arterial blood gas - taken before, 5, 30 min, 4-6 hours and 20-26 hours after medication administration. These measures will be used to calculate cerebral oxygen kinetic variables including delivery and consumption.
Sponsors
A/Prof Michael Stark
Eligibility
Sex/Gender
All
Age
No minimum to 7 Days
Healthy volunteers
No
Inclusion criteria
1.Preterm newborns <30 weeks gestational age admitted to the WCH NICU and 2. Diagnosis of a clinically significant ductus arteriosus requiring medical therapy as determined by the clinical team.
Exclusion criteria
1..Significant congenital abnormality 2. Clinically unstable and not expected to survive 3. Structural heart disease
Outcome results
None listed