Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000532404
Ethics application status
Approved
Date submitted
5/04/2007
Date registered
17/10/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial to see if closing the arterial duct improves outcome in very premature babies
Scientific title
Double blind randomised trial of the effect indomethacin for closure of patent ductus arteriosus on death and chronic lung disease in very preterm infants.
The Indomethacin Ductus Closure Effect trial: The INDUCE trial
Universal Trial Number (UTN)
Trial acronym
INDUCE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature babies 2145 0
Patent ductus arteriosus 2146 0
Death 2147 0
Chronic lung disease 2148 0
Condition category
Condition code
Reproductive Health and Childbirth 2241 2241 0 0
Complications of newborn
Cardiovascular 2559 2559 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous indomethacin 200mcg/kg x1 then 100mcg/kg x5, all at 24 hourly intervals. Prepared as standard dilution so 0.4ml/kg given for 1st dose then 0.2ml/kg
Intervention code [1] 2201 0
Treatment: Drugs
Comparator / control treatment
Placebo (intravenous saline) administered as same volume as indomethacin, 0.4ml/kg for 1st dose then 0.2ml/kg for remaining 5 doses, all at 24 hourly intervals.
Control group
Placebo

Outcomes
Primary outcome [1] 3101 0
Chronic lung disease
Timepoint [1] 3101 0
36 weeks post-menstrual age
Primary outcome [2] 3102 0
Death
Timepoint [2] 3102 0
36 weeks post-menstrual age
Secondary outcome [1] 5205 0
Retinopathy
Timepoint [1] 5205 0
Retinal maturity (= vascularity progressed to zone 3).
Secondary outcome [2] 5206 0
Intraventricular haemorrhage
Timepoint [2] 5206 0
Hospital discharge
Secondary outcome [3] 5207 0
Necrotising enterocolitis
Timepoint [3] 5207 0
Hospital discharge
Secondary outcome [4] 5210 0
long term respiratory morbidity
Timepoint [4] 5210 0
2 years
Secondary outcome [5] 5211 0
neurodevelopmental outcome
Timepoint [5] 5211 0
2 years

Eligibility
Key inclusion criteria
Birthweight <1250g or gestational age <28 weeks. Large patent ductus arterisous diagnosed by echocardiography at 3 days of age.
Minimum age
2 Days
Maximum age
28 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant congenital anomalies, likely death within hours, previous indomethacin, contraindication to indomethacin.

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)
Parental consent and then randomised. Indomethacin or placebo prepared in yellow coloured syringes (indomethacin is a yellowish solution) prepared by hospital pharmacy. The randomisation list has been prepared in blocks in random order. It is held by the Clinical Trials Unit of the Hospital Pharmacy and the Chair of the Data Safety Monitoring Committee. The list is not available to clinicians or investigators. Randomisation is by allocating the baby the next number and faxing a perscription to Pharmacy. Pharmacy line up the number with the randomisation list and prepare the drug. The Clinical Trials Unit in Pharmacy acts as the central randomisation site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation stratified above or below 27 weeks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 508 0
New Zealand
State/province [1] 508 0
Auckland
Country [2] 509 0
New Zealand
State/province [2] 509 0

Funding & Sponsors
Funding source category [1] 2400 0
Charities/Societies/Foundations
Name [1] 2400 0
A+ trust
Country [1] 2400 0
New Zealand
Funding source category [2] 2401 0
Charities/Societies/Foundations
Name [2] 2401 0
Auckland Medical Research Foundation
Country [2] 2401 0
New Zealand
Primary sponsor type
Individual
Name
Dr David Knight
Address
Auckalnd City Hospital
Auckland
NZ
Country
New Zealand
Secondary sponsor category [1] 2174 0
Hospital
Name [1] 2174 0
Auckland City Hospital Research Review Committee
Address [1] 2174 0
Country [1] 2174 0
New Zealand
Secondary sponsor category [2] 2449 0
None
Name [2] 2449 0
Address [2] 2449 0
Country [2] 2449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4235 0
NZ Health and Disability Ethics Committees, Northern X Regional Ethics Committee
Ethics committee address [1] 4235 0
Ethics committee country [1] 4235 0
New Zealand
Date submitted for ethics approval [1] 4235 0
Approval date [1] 4235 0
28/06/2007
Ethics approval number [1] 4235 0
NTX/07/04/030

Summary
Brief summary
Patent ductus arteriosus is a common complication in very preterm infants. Although it is treated aggressively with indomethacin, there is little or no evidence that this treatment improves outcome in these infants. This is a pilot study to investigate if outcome is improved. If the pilot is successful, a large international trial will be organised.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27794 0
Address 27794 0
Country 27794 0
Phone 27794 0
Fax 27794 0
Email 27794 0
Contact person for public queries
Name 10880 0
David Knight
Address 10880 0
Newborn Services
Auckland City Hospital
Park Rd
Auckland
Country 10880 0
New Zealand
Phone 10880 0
+64 9 3074949
Fax 10880 0
Email 10880 0
davidk@adhb.govt.nz
Contact person for scientific queries
Name 1808 0
David Knight
Address 1808 0
Newborn Services
Auckland City Hospital
Park Rd
Auckland
Country 1808 0
New Zealand
Phone 1808 0
+64 9 3074949
Fax 1808 0
Email 1808 0
davidk@adhb.govt.nz

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
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Documents added automatically
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