Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000579695
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
4/10/2005
Date last updated
9/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Heparin In Total Parenteral Nutrition
Scientific title
Randomised controlled trial of heparin in total parenteral nutrition to reduce the complications of peripherally inserted central venous catheters (long lines) in neonates.
Universal Trial Number (UTN)
Trial acronym
HILL TOP Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous catheter complications, in particular nosocomial central line associated infections. 706 0
Condition category
Condition code
Infection 4452 4452 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised double blind controlled trial with Heparin added to the total parenteral nutrition at a concentration of 0.5IU/mL. The intervention continues for as long as the infant is receiving total parenteral nutrition or a predetermined end site is reached, such as confirmed central line infection.
Intervention code [1] 437 0
None
Comparator / control treatment
Controls have total parenteral nutrition without heparin.
Control group
Active

Outcomes
Primary outcome [1] 994 0
Definite or probable baterial line infection while actively on the HILL TOP Trial is the primary outcome. We are looking at the number of definite or probable bacterial line infections while on the trial per total number of infants enrolled in each arm. The infant is considered actively "on the trial" from the time they have a long line inserted until either a primary outcome is reached (ie. definite or probable infection) or the long line is removed. The reason for coming off the trial is recorded.
Timepoint [1] 994 0
While long line remains in situ
Primary outcome [2] 995 0
Rate of definite or probable bacterial line infections while on the trial per total long line days in each arm. The infant is considered actively "on the trial" from the time they have a long line inserted until either a primary outcome is reached (ie. definite or probable infection) or the long line is removed. The reason for coming off the trial is recorded.
Timepoint [2] 995 0
While long line remains in situ
Secondary outcome [1] 1886 0
Most of the secondary outcomes are also recorded while the infant is actively on the trial. Each infant can only have a single outcome as the reason for exiting the trial and the primary outcome takes precedence. These secondary outcomes recorded while actively on the trial are:
The number of bacteraemic episodes with organisms not commonly associated with line sepsis per total number of infants in each group.
The number of definite or probable Candida line infections per total number of infants in each group.
The number of infants who had the long line removed because of extravasation or occlusion per total number of infants in each group.
The number of infants who had the long line removed because the line was no longer required per total number of infants in each group.
We are also looking at the number of infants with progression of intraventricular haemorrhage per total number of infants in each group. The definition being progression from a minor grade IVH to a severe grade IVH comparing ultrasound scans taken before starting the trial to the first scan after exiting the trial.
Timepoint [1] 1886 0
While long line remains in situ

Eligibility
Key inclusion criteria
All infants admitted to the Wellington Neonatal Unit requiring there first long line were eligible for inclusion.
Minimum age
0 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They were excluded if they had previously had an effective long line inserted and utilised. no other exclusion criteria.

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)
Computer generated randomisation lists held in pharmacy production and infants allocated there, thus concealing allocation from parents, medical and nursing staff and investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification at randomisation was done on the basis of size (<850g, 850-2000, >2000g). Treatment allocation was balanced within blocks of random length. Random numbers were generated using the ranuni function of the SAS (SAS Institute Inc., Cary, NC) software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 196 0
New Zealand
State/province [1] 196 0

Funding & Sponsors
Funding source category [1] 866 0
Charities/Societies/Foundations
Name [1] 866 0
Baxter Clinical Nutrition Grant 2004
Country [1] 866 0
New Zealand
Funding source category [2] 867 0
Charities/Societies/Foundations
Name [2] 867 0
NZ Branch of the RACP
Country [2] 867 0
New Zealand
Primary sponsor type
Individual
Name
Dr Pita Birch
Address
Royal Women's Hospital
Melbourne
Victoria
Country
Australia
Secondary sponsor category [1] 731 0
Individual
Name [1] 731 0
Dr Michael Hewson
Address [1] 731 0
Capital and Coast District Health Board Wellington Hospital Riddiford Street Private Bag 7902 Wellington South Wellington 6002
Country [1] 731 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2129 0
Wellington Neonatal Unit-Central Regional Ethics Committee
Ethics committee address [1] 2129 0
Ethics committee country [1] 2129 0
New Zealand
Date submitted for ethics approval [1] 2129 0
Approval date [1] 2129 0
Ethics approval number [1] 2129 0

Summary
Brief summary
In this trial we are testing the hypothesis that the addition of low dose heparin to total parenteral nutrition reduces the complications associated with long lines in neonates, particularly long line infections. We are investigating the possible benefits of heparin in improving the delivery of TPN to sick or premature neonates. In this study half of the babies will have heparin added to their TPN and the other half will have TPN without heparin. No one, except for the pharmacists, will know which babies are having heparin and which ones are not and this makes the trial double blind. At the end of the study we will compare the two groups to see if the babies that have had heparin have had less infections or less complications in general.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35680 0
Address 35680 0
Country 35680 0
Phone 35680 0
Fax 35680 0
Email 35680 0
Contact person for public queries
Name 9626 0
Dr Pita Birch
Address 9626 0
Royal Women's Hospital
Melbourne
Country 9626 0
Australia
Phone 9626 0
+64 21 2619727
Fax 9626 0
N/A
Email 9626 0
[email protected]
Contact person for scientific queries
Name 554 0
Dr Michael Hewson
Address 554 0
Capital and Coast District Health Board
Wellington Hospital
Riddiford Street
Private Bag 7902
Wellington South Wellington 6002
Country 554 0
New Zealand
Phone 554 0
+64 4 3855999
Fax 554 0
+64 4 3855309
Email 554 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.