Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001049268
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
22/06/2018
Date last updated
22/06/2018
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
None
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

Intervention/exposure
Study type
Observational
Patient registry
False
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
Active

Outcomes
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
N/A
Timepoint [1] 348262 0
N/A

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1..Significant congenital abnormality
2. Clinically unstable and not expected to survive
3. Structural heart disease

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
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
Hospital
Name [1] 299822 0
Women's and Children's Hospital
Country [1] 299822 0
Australia
Primary sponsor type
Individual
Name
A/Prof Michael Stark
Address
Department of Neonatal Medicine
Women's and Children's Hospital
72 King William Road
North Adelaide, South Australia 5006
Country
Australia
Secondary sponsor category [1] 299177 0
None
Name [1] 299177 0
Not applicable
Address [1] 299177 0
Not applicable
Country [1] 299177 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 300702 0
Approval date [1] 300702 0
30/05/2018
Ethics approval number [1] 300702 0
HREC/18/WCHN/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 84530 0
+61 8 8161 7631
Fax 84530 0
+61 8 8161 7654
Email 84530 0
michael.stark@adelaide.edu.au
Contact person for public queries
Name 84531 0
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
Australia
Phone 84531 0
+61 8 8161 7631
Fax 84531 0
+61 8 8161 7654
Email 84531 0
nina.ziegler@sa.gov.au
Contact person for scientific queries
Name 84532 0
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
Australia
Phone 84532 0
+61 8 8161 7631
Fax 84532 0
+61 8 8161 7654
Email 84532 0
nina.ziegler@sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.