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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
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 postcode(s) [1] 885 0

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 5498 0
Approval date [1] 5498 0
Ethics approval number [1] 5498 0

Brief summary
Trial website
Trial related presentations / publications
Public notes

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
Phone 11812 0
+61 2 99267509
Fax 11812 0
Email 11812 0
Contact person for scientific queries
Name 2740 0
Martin Kluckow
Address 2740 0
Royal North Shore Hospital
St Leonards
Country 2740 0
Phone 2740 0
+61 2 99267509
Fax 2740 0
Email 2740 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary