Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000295347
Ethics application status
Approved
Date submitted
9/06/2008
Date registered
13/06/2008
Date last updated
18/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Targeting of treatment of the patent ductus arteriosus using early echocardiography
Scientific title
Response of premature infants born before 29 weeks gestation to early targeted treatment with indomethacin vs placebo in terms of the combined outcome of mortality/abnormal head ultrasound at nursery discharge.
Universal Trial Number (UTN)
Trial acronym
DETECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patent ductus arteriosus 3244 0
Condition category
Condition code
Cardiovascular 3408 3408 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indomethacin (0.2mg loading dose intravenously followed by two doses of 0.1mg/kg at 24 hour intervals intravenously) given in first 12 hours of life in high risk premature infants with patent ductus arteriosus failing to constrict naturally as defined by an echocardiogram.
Intervention code [1] 2985 0
Treatment: Drugs
Intervention code [2] 2999 0
Early detection / Screening
Comparator / control treatment
Echocardiogram in first 12 hours of life - no treatment if ductus constricted, 3 doses of normal saline placebo IV (0.1mls/kg followed by two doses of 0.05mls/kg) if ductus defined as large on echocardiogram.
Control group
Placebo

Outcomes
Primary outcome [1] 4306 0
Combined death and abnormal cranial ultrasound
Timepoint [1] 4306 0
Nursery discharge
Secondary outcome [1] 7253 0
Chronic lung disease as measured by need for any supplemental oxygen or pressure support
Timepoint [1] 7253 0
36 weeks corrected post menstrual age

Eligibility
Key inclusion criteria
Infants born < 29 weeks gestational age
Infants < 12 hours old
Echocardiogram to assess ductal size able to be performed
Minimum age
3 Hours
Maximum age
12 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1] Intraventricular haemorrhage grade 3 – 4 at time of initial scan.
2] Baby is clinically unstable and not expected to survive.
3] Congenital anomalies predicted to influence neurodevelopmental outcome
4] Structural heart disease
5] R->L shunt - infants with near systemic or suprasystemic pulmonary pressure who may benefit from some RV pressure relief – R>L ductal flow for >33% of cardiac cycle. Rescan in same 12 hour time frame.
6] Contraindication to use of indomethacin or ibuprofen (Platelet count <50,000, Creatinine >120 micromol/L, use of NSAID antenatally)
7] Unlikely to be able to commence first dose of treatment by 12 hours of age
8] Consent not given

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)
A permutated block randomisation method was used to develop a randomisation table for each gestational age group. Pharmacists not involved with the care of the infant allocated sequential study numbers to masked syringes of either placebo or indomethacin. After study enrolment the next sequential numbered syringe for that block is used for treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number sequence was generated by permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 885 0
2065

Funding & Sponsors
Funding source category [1] 3467 0
Self funded/Unfunded
Name [1] 3467 0
Country [1] 3467 0
Primary sponsor type
Individual
Name
Martin Kluckow
Address
Royal North Shore Hospital
Pacific Highway
St Leonards
Country
Australia
Secondary sponsor category [1] 3112 0
Hospital
Name [1] 3112 0
Royal North Shore Hospital
Address [1] 3112 0
Pacific Highway
St Leonards
Country [1] 3112 0
Australia
Other collaborator category [1] 302 0
Individual
Name [1] 302 0
Dr Andy Gill
Neonatal Unit
King Edward Memorial Hospital
Address [1] 302 0
374 Bagot Road
Subiaco
Perth
Country [1] 302 0
Australia
Other collaborator category [2] 303 0
Individual
Name [2] 303 0
Dr Nick Evans
Neonatal Unit
Royal Prince Alfred Hospital
Address [2] 303 0
Missenden Road
Camperdown
Country [2] 303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5498 0
Harbour Northern Sydney Central Coast
Ethics committee address [1] 5498 0
Research Office
Level 4, Vindin House
Royal North Shore Hospital
Ethics committee country [1] 5498 0
Australia
Date submitted for ethics approval [1] 5498 0
Approval date [1] 5498 0
17/04/2008
Ethics approval number [1] 5498 0
0802-012M

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

Contacts
Principal investigator
Name 28655 0
Address 28655 0
Country 28655 0
Phone 28655 0
Fax 28655 0
Email 28655 0
Contact person for public queries
Name 11812 0
Martin Kluckow
Address 11812 0
Royal North Shore Hospital
St Leonards
Country 11812 0
Australia
Phone 11812 0
+61 2 99267509
Fax 11812 0
Email 11812 0
[email protected]
Contact person for scientific queries
Name 2740 0
Martin Kluckow
Address 2740 0
Royal North Shore Hospital
St Leonards
Country 2740 0
Australia
Phone 2740 0
+61 2 99267509
Fax 2740 0
Email 2740 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.