Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000145909
Ethics application status
Approved
Date submitted
7/02/2011
Date registered
8/02/2011
Date last updated
8/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Nebulised pentoxifylline for the prevention of chronic lung disease in extremely preterm infants
Scientific title
Does treating extremely preterm infants with inhaled Pentoxifylline vs Saline placebo lead to a reduction in chronic lung disease?
Secondary ID [1] 252829 0
Nil
Universal Trial Number (UTN)
U1111-1117-3748
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchopulmonary dysplasia 258336 0
Premature birth 261124 0
Condition category
Condition code
Respiratory 258522 258522 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 259277 259277 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nebulised Pentoxifylline at 20 mg/kg (1ml/kg), 6 hourly for 10 days. If still ventilated or requiring>= 30% oxygen 5 days after completing course, baby will receive a repeat 10 day course.
Intervention code [1] 257351 0
Treatment: Drugs
Intervention code [2] 257998 0
Prevention
Comparator / control treatment
Nebulised 0.9% sodium chloride at 1ml/kg in the same dosing regime as above.
Control group
Placebo

Outcomes
Primary outcome [1] 259363 0
Duration on supplemental oxygen (hours) at 40 week Post menstrual age.
Timepoint [1] 259363 0
At 40 weeks post menstrual age.
Secondary outcome [1] 265857 0
Bronchopulmonary dysplasia or death
Timepoint [1] 265857 0
At 40 weeks post menstrual age
Secondary outcome [2] 265858 0
Mortality to hospital discharge
Timepoint [2] 265858 0
At discharge
Secondary outcome [3] 265859 0
Duration of hospital stay
Timepoint [3] 265859 0
At discharge

Eligibility
Key inclusion criteria
Preterm infants < 28 w GA will be eligible for enrolment if they require mechanical ventilation greater than or equal to 30% supplemental oxygen at 72 – 168 h of life and if written informed parental consent is given.
Minimum age
23 Weeks
Maximum age
27 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital malformations of the thorax (e.g. congenital diaphragmatic hernia, congenital cystic adenomatoid malformation of the lung, esophageal atresia)
Major cardiac malformations. (Infants with persistent ductus arteriosus or hemodynamically non-significant atrial or ventricular septal defect may be included in the trial).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Babies born between 23 weeks and 27 weeks plus 6 days will be enrolled following full informed parental consent. They will then be randomized to receive placebo or interventional drug. A randomisation list will be created by the coordinating trial pharmacist using a computer-based random number generator.Only the trial pharmacist will know contents of the trial drug. Everyone else will be blinded. The pharmacy will provde 1.5ml syringes of clear colourless undifferentiable liquid. These will then be nebulised in the standard way by the nursing staff as prescribed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257801 0
Hospital
Name [1] 257801 0
King Edward Memorial Hospital, NCCU
Country [1] 257801 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital, NCCU
Address
378 Bagot Road
Subiaco,
Perth
WA 6008
Country
Australia
Secondary sponsor category [1] 257005 0
None
Name [1] 257005 0
Address [1] 257005 0
Country [1] 257005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259823 0
King Edward Memorial Hospital Ethics Committee
Ethics committee address [1] 259823 0
378 Bagot Road
Subiaco,
Perth
WA 6008
Ethics committee country [1] 259823 0
Australia
Date submitted for ethics approval [1] 259823 0
Approval date [1] 259823 0
01/12/2009
Ethics approval number [1] 259823 0
1763/EW
Ethics committee name [2] 260084 0
WNHS Ethics Committee
Ethics committee address [2] 260084 0
373 Bagot Road, Subiaco. Perth, WA6008.
Ethics committee country [2] 260084 0
Australia
Date submitted for ethics approval [2] 260084 0
Approval date [2] 260084 0
01/12/2009
Ethics approval number [2] 260084 0
1763/EW

Summary
Brief summary
Chronic Lung Disease (Bronchopulmonary dyplasia) is a common and serious complication in extremely preterm infants below 28 weeks. In 2008 in Western Australia, over 120 infants were born at less than 28 weeks. 28% of the survivors developed Chronic lung disease.
With it’s immunomodulatory effects, Pentoxifylline is emerging as a promising treatment for conditions such as sepsis, NEC and Chronic Lung disease.
Whilst trials are encouraging for Pentoxifylline’s effect on Chronic lung disease; well organized, properly blinded trials have not been published. This trial aims to address this and discover whether nebulized pentoxifylline might help prevent bronchopulmonary dysplasia in extremely preterm infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31742 0
Address 31742 0
Country 31742 0
Phone 31742 0
Fax 31742 0
Email 31742 0
Contact person for public queries
Name 14989 0
Dr Simon Pirie
Address 14989 0
Neonatal Clinical Care Unit,
King Edward Memorial Hospital,
378 Bagot Road,
Subiaco,
Perth,
WA 6008
Country 14989 0
Australia
Phone 14989 0
0061892408222
Fax 14989 0
Email 14989 0
simon.pirie@health.wa.gov.au
Contact person for scientific queries
Name 5917 0
Dr Sanjay Patole
Address 5917 0
Neonatal Clinical Care Unit,
King Edward Memorial Hospital,
378 Bagot Road,
Subiaco,
Perth,
WA 6008
Country 5917 0
Australia
Phone 5917 0
0061892408222
Fax 5917 0
Email 5917 0
sanjay.patole@health.wa.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
SourceTitleYear of PublicationDOI
EmbaseNebulized pentoxifylline for reducing the duration of oxygen supplementation in extremely preterm neonates.2015https://dx.doi.org/10.1016/j.jpeds.2015.01.040
N.B. These documents automatically identified may not have been verified by the study sponsor.