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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain blood flow responses in preterm babies treated with indomethacin or ibuprofen for patent ductus arteriosus
Scientific title
Cerebral oxygen kinetic and haemodynamic responses to indomethacin and ibuprofen in preterm newborns treated for a clinically significant patent ductus arteriosus
Secondary ID [1] 295233 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patent ductus arteriosus 308397 0
Condition category
Condition code
Cardiovascular 307387 307387 0 0
Other cardiovascular diseases
Reproductive Health and Childbirth 307453 307453 0 0
Complications of newborn

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 301569 0
Not applicable
Comparator / control treatment
Ibuprofen 20mg/kg intravenous over 5 mins
Control group

Primary outcome [1] 306363 0
i. Comparison of cerebral oxygen kinetics using either indomethacin or ibuprofen with direct comparison at each time point
Cerebral oxygen kinetics will be assessed using the following measures:
1: Near-infrared spectroscopy derived regional tissue oxygen saturation (rS02)
3: Co-oximetry derived arterial oxygen saturation (Sa02)
2: ultrasound derived internal carotid blood flow
3: Arterial blood gas measures - Haemoglobin, Pa02
From this, cerebral oxygen delivery, consumption and extraction will be calculated.
This is a composite primary outcome
Timepoint [1] 306363 0
1. baseline
2. 5 minutes post medication administration - primary timepoint
2. 30 minutes post medication administration
3. 4 hours post medication administration
Secondary outcome [1] 348262 0
Timepoint [1] 348262 0

Key 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.
Minimum age
No limit
Maximum age
7 Days
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1..Significant congenital abnormality
2. Clinically unstable and not expected to survive
3. Structural heart disease

Study design
Natural history
Defined population
Statistical methods / analysis

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 11178 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 23019 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 299822 0
Name [1] 299822 0
Women's and Children's Hospital
Address [1] 299822 0
72 King William Road
North Adelaide, South Australia 5006
Country [1] 299822 0
Primary sponsor type
A/Prof Michael Stark
Department of Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide, South Australia 5006
Secondary sponsor category [1] 299177 0
Name [1] 299177 0
Not applicable
Address [1] 299177 0
Not applicable
Country [1] 299177 0

Ethics approval
Ethics application status
Ethics committee name [1] 300702 0
Women's and Children's Health Network Human Research Ethics Committe
Ethics committee address [1] 300702 0
Ethics committee country [1] 300702 0
Date submitted for ethics approval [1] 300702 0
Approval date [1] 300702 0
Ethics approval number [1] 300702 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 84530 0
A/Prof Michael Stark
Address 84530 0
Department of Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide, South Australia 5006
Country 84530 0
Phone 84530 0
+61 8 8161 7631
Fax 84530 0
+61 8 8161 7654
Email 84530 0
Contact person for public queries
Name 84531 0
Dr Nina Ziegler
Address 84531 0
Department of Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide, South Australia 5006
Country 84531 0
Phone 84531 0
+61 8 8161 7631
Fax 84531 0
+61 8 8161 7654
Email 84531 0
Contact person for scientific queries
Name 84532 0
Dr Nina Ziegler
Address 84532 0
Department of Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide, South Australia 5006
Country 84532 0
Phone 84532 0
+61 8 8161 7631
Fax 84532 0
+61 8 8161 7654
Email 84532 0

No information has been provided regarding IPD availability
Summary results
No Results