Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000152426
Ethics application status
Approved
Date submitted
21/02/2007
Date registered
1/03/2007
Date last updated
1/03/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants
Scientific title
Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low systemic blood flow in preterm infants 1652 0
Condition category
Condition code
Reproductive Health and Childbirth 1758 1758 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dopamine vs dobutamine by continuous intravenous infusion. Two dosage steps for each drug. 10 and 20 micrograms/kg/min. If Doppler ultrasound measures of systemic blood flow increased on 10 microgram/kg/min then they remain on that dose. If no increase in systemic blood flow at 10 micrograms/kg/min then they increased to 20 micrograms/kg/min. If they increased systemic blood flow on 20 micrograms/kg/min then they remain on that dose. If no increase in systemic blood flow at 20 micrograms/kg/min then crossover immediately to the other drug with no washout period and the dose escalation process repeated with the other syringe (drug). The infusion was maintained until 24 hours of age then weaned at the discretion of the treating medical staff.
Intervention code [1] 1617 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2455 0
Change in systemic blood flow
Timepoint [1] 2455 0
Measured 30 minutes after commencement of the intervention or dose change and maintained for first 24 hours after birth with repeat measures at 12 and 24 hours of age.
Secondary outcome [1] 4219 0
Mortality
Timepoint [1] 4219 0
Assessed at hospital discharge and at 1 year of ages
Secondary outcome [2] 4220 0
Intraventricular haemorrhage on serial (5,12,24 and 48 hours of age then day 7) ultrasound through the first week.
Timepoint [2] 4220 0
Secondary outcome [3] 4221 0
Neurodevelopmental outcome
Timepoint [3] 4221 0
At 3 years of age.

Eligibility
Key inclusion criteria
Born before 30 weeks and low systemic blood flow.
Minimum age
Not stated
Maximum age
30 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major intraventricular haemorrhage before intervention commences, not expected to survive.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered syringes randomly assigned to dopamine or dobutamine in pharmacy. Each baby has two syringes labelled (Study ID no) and C or D. Baby always starts C first and the drugs are randomly assigned between the two syringes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Everyone was blinded except the clinical trial pharmacist. So baby (subject), parents of subject, therapists and assessor.
Phase
Phase 3
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1911 0
Government body
Name [1] 1911 0
National Health and Medical Research Council
Country [1] 1911 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nick Evans
Address
Country
Secondary sponsor category [1] 1723 0
None
Name [1] 1723 0
No secondary sponsor
Address [1] 1723 0
Country [1] 1723 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3555 0
Central Sydney Area Health Service ethics committee
Ethics committee address [1] 3555 0
Ethics committee country [1] 3555 0
Australia
Date submitted for ethics approval [1] 3555 0
Approval date [1] 3555 0
10/10/1997
Ethics approval number [1] 3555 0
X97-0060

Summary
Brief summary
Low systemic blood flow in the early hours after birth is a common problem in very preterm babies. It is associated with a range of adverse outcomes. This trial aims to test the efficacy of the two commonly used inotropes in preterm babies. Inotropes are drugs that improve the pumping performance of the heart.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27551 0
Address 27551 0
Country 27551 0
Phone 27551 0
Fax 27551 0
Email 27551 0
Contact person for public queries
Name 10806 0
Nick Evans
Address 10806 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 10806 0
Australia
Phone 10806 0
+61 2 95156253
Fax 10806 0
+61 2 95504275
Email 10806 0
[email protected]
Contact person for scientific queries
Name 1734 0
Nick Evans
Address 1734 0
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1734 0
Australia
Phone 1734 0
+61 2 95156253
Fax 1734 0
+61 2 95504375
Email 1734 0
[email protected]

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.