Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000273583
Ethics application status
Approved
Date submitted
12/07/2001
Date registered
12/07/2001
Date last updated
3/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
International neonatal immunotherapy study
Scientific title
Randomised controlled trial of intravenous immunoglobulin of neonates with sepsis using intravenous immunoglobulin (Intragam P) and being treated with antibiotics. Primary outcomes are mortality and morbidity.
Secondary ID [1] 29 0
Perinatal Trials Registry: PTR373
Universal Trial Number (UTN)
Trial acronym
INIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infants with sepsis. Infants being treated with antibiotics are eligible. Infants can be preterm or term. 30 0
Condition category
Condition code
Reproductive Health and Childbirth 34 34 0 0
Childbirth and postnatal care
Inflammatory and Immune System 35 35 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of immunoglobulin (Intragam P) (500mg (10ml) per kg).
Administered twice in total (treatment given over 4-6 hours and then repeated 48 hours later).
Intervention code [1] 1105 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline).
Administered twice in total (treatment given over 4-6 hours and then repeated 48 hours later).
Control group
Placebo

Outcomes
Primary outcome [1] 63 0
Mortality or major disability
Timepoint [1] 63 0
At 2 yrs (corrected for gestational age at birth)
Secondary outcome [1] 105 0
1. Mortality
Timepoint [1] 105 0
Before 2 years
Secondary outcome [2] 106 0
Chronic lung disease or major cerebral abnormality
Timepoint [2] 106 0
Before hospital discharge.
Secondary outcome [3] 107 0
Significant positive culture
Timepoint [3] 107 0
After trial entry.
Secondary outcome [4] 108 0
Pneumonia
Timepoint [4] 108 0
hospital discharge
Secondary outcome [5] 109 0
Necrotising enterocolitis
Timepoint [5] 109 0
hospital discharge
Secondary outcome [6] 110 0
Duration of respiratory support.
Timepoint [6] 110 0
hospital discharge
Secondary outcome [7] 111 0
2. Major disability and Non major disability
Timepoint [7] 111 0
At 2 years
Secondary outcome [8] 112 0
3. Length of hospital stay and number of hospital admissions.
Timepoint [8] 112 0
2 years (corrected for gestational age at birth)

Eligibility
Key inclusion criteria
Infants are eligible if: they are receiving antibiotics with clinical evidence of definite or highly probable sepsis, there is substantial uncertainty that IVIG is indicated, birth weight is less than 1500g OR already has positive blood or cerebro spinal fluid culture OR receiving artifical ventilation.
Minimum age
0 Days
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
IVIG already given or thought to be needed or contra-indicated.

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)
Treatment allocations are provided to central pharmacy of the hospital. Allocation involves contacting pharmacist at the hospital to allocate a treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks with different block sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Either one or the other treatment is allocated
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2001
Actual
20/02/2002
Date of last participant enrolment
Anticipated
Actual
21/05/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 44 0
Government body
Name [1] 44 0
National Health & Medical Research Council
Country [1] 44 0
Australia
Funding source category [2] 45 0
Government body
Name [2] 45 0
Health Research Council (NZ)
Country [2] 45 0
New Zealand
Funding source category [3] 46 0
Government body
Name [3] 46 0
UK Medical Research Council
Country [3] 46 0
United Kingdom
Funding source category [4] 47 0
Charities/Societies/Foundations
Name [4] 47 0
Financial Markets Foundation for Children
Country [4] 47 0
Australia
Funding source category [5] 48 0
University
Name [5] 48 0
Sesqui Grant University of Sydney
Country [5] 48 0
Australia
Funding source category [6] 49 0
Government body
Name [6] 49 0
Commonwealth Scientific Laboratories
Country [6] 49 0
Australia
Funding source category [7] 50 0
Charities/Societies/Foundations
Name [7] 50 0
Telstra Foundation
Country [7] 50 0
Australia
Funding source category [8] 51 0
University
Name [8] 51 0
University of Sydney National Health & Medical Research Council Clinical Trials Centre
Country [8] 51 0
Australia
Funding source category [9] 52 0
Charities/Societies/Foundations
Name [9] 52 0
Ian Potter Travel Grant
Country [9] 52 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
City Rd, Darlington New South Wales 2008
Country
Australia
Secondary sponsor category [1] 38 0
Individual
Name [1] 38 0
Prof. William Tarnow-Mordi
Address [1] 38 0
NHMRC Clinical Trial Centre
Locked Bag 77
Camperdown NSW 1450
Australia
Country [1] 38 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 328 0
Westmead Hospital
Ethics committee address [1] 328 0
Ethics committee country [1] 328 0
Australia
Date submitted for ethics approval [1] 328 0
Approval date [1] 328 0
17/12/2001
Ethics approval number [1] 328 0
2001/7/4.22 (1080)
Ethics committee name [2] 329 0
Royal Hospital for Women
Ethics committee address [2] 329 0
Ethics committee country [2] 329 0
Australia
Date submitted for ethics approval [2] 329 0
Approval date [2] 329 0
19/12/2001
Ethics approval number [2] 329 0
01/275
Ethics committee name [3] 330 0
Royal Hobart
Ethics committee address [3] 330 0
Ethics committee country [3] 330 0
Australia
Date submitted for ethics approval [3] 330 0
Approval date [3] 330 0
14/08/2002
Ethics approval number [3] 330 0
ISRCTN 94984750
Ethics committee name [4] 331 0
John Hunter Hospital
Ethics committee address [4] 331 0
Ethics committee country [4] 331 0
Australia
Date submitted for ethics approval [4] 331 0
Approval date [4] 331 0
17/08/2002
Ethics approval number [4] 331 0
02/07/10/3.06
Ethics committee name [5] 332 0
Monash Medical Centre
Ethics committee address [5] 332 0
Ethics committee country [5] 332 0
Australia
Date submitted for ethics approval [5] 332 0
Approval date [5] 332 0
09/07/2002
Ethics approval number [5] 332 0
02045B
Ethics committee name [6] 333 0
The Canberra Hospital
Ethics committee address [6] 333 0
Ethics committee country [6] 333 0
Australia
Date submitted for ethics approval [6] 333 0
Approval date [6] 333 0
13/05/2002
Ethics approval number [6] 333 0
ETH.2/02.74
Ethics committee name [7] 334 0
RPA women and Babies
Ethics committee address [7] 334 0
Ethics committee country [7] 334 0
Australia
Date submitted for ethics approval [7] 334 0
Approval date [7] 334 0
16/07/2002
Ethics approval number [7] 334 0
COR05-02; X02-0012
Ethics committee name [8] 335 0
Sydney Children's
Ethics committee address [8] 335 0
Ethics committee country [8] 335 0
Australia
Date submitted for ethics approval [8] 335 0
Approval date [8] 335 0
05/01/2004
Ethics approval number [8] 335 0
01/275
Ethics committee name [9] 336 0
Flinders Medical Centre
Ethics committee address [9] 336 0
Ethics committee country [9] 336 0
Australia
Date submitted for ethics approval [9] 336 0
Approval date [9] 336 0
22/09/2003
Ethics approval number [9] 336 0
11/034
Ethics committee name [10] 337 0
Royal Women's
Ethics committee address [10] 337 0
Ethics committee country [10] 337 0
Australia
Date submitted for ethics approval [10] 337 0
Approval date [10] 337 0
22/09/2003
Ethics approval number [10] 337 0
03/05
Ethics committee name [11] 338 0
Mercy Hospital for Women
Ethics committee address [11] 338 0
Ethics committee country [11] 338 0
Australia
Date submitted for ethics approval [11] 338 0
Approval date [11] 338 0
02/05/2003
Ethics approval number [11] 338 0
R03/03
Ethics committee name [12] 339 0
Nepean
Ethics committee address [12] 339 0
Ethics committee country [12] 339 0
Australia
Date submitted for ethics approval [12] 339 0
Approval date [12] 339 0
27/08/2002
Ethics approval number [12] 339 0
02/054
Ethics committee name [13] 340 0
Royal Children's
Ethics committee address [13] 340 0
Ethics committee country [13] 340 0
Australia
Date submitted for ethics approval [13] 340 0
Approval date [13] 340 0
06/05/2003
Ethics approval number [13] 340 0
23001A
Ethics committee name [14] 341 0
Royal North Shore Hospital
Ethics committee address [14] 341 0
Ethics committee country [14] 341 0
Australia
Date submitted for ethics approval [14] 341 0
Approval date [14] 341 0
04/03/2003
Ethics approval number [14] 341 0
0209-145M
Ethics committee name [15] 342 0
Liverpool
Ethics committee address [15] 342 0
Ethics committee country [15] 342 0
Australia
Date submitted for ethics approval [15] 342 0
Approval date [15] 342 0
23/09/2002
Ethics approval number [15] 342 0
02/106
Ethics committee name [16] 343 0
The Children's Hospital at Westmead
Ethics committee address [16] 343 0
Ethics committee country [16] 343 0
Australia
Date submitted for ethics approval [16] 343 0
Approval date [16] 343 0
15/07/2002
Ethics approval number [16] 343 0
2002/032
Ethics committee name [17] 344 0
Wellington Women's Hospital
Ethics committee address [17] 344 0
Ethics committee country [17] 344 0
New Zealand
Date submitted for ethics approval [17] 344 0
Approval date [17] 344 0
Ethics approval number [17] 344 0
Ethics committee name [18] 345 0
Palmerston North Hospital
Ethics committee address [18] 345 0
Ethics committee country [18] 345 0
New Zealand
Date submitted for ethics approval [18] 345 0
Approval date [18] 345 0
Ethics approval number [18] 345 0
Ethics committee name [19] 346 0
Dunedin Hospital
Ethics committee address [19] 346 0
Ethics committee country [19] 346 0
New Zealand
Date submitted for ethics approval [19] 346 0
Approval date [19] 346 0
Ethics approval number [19] 346 0
Ethics committee name [20] 347 0
National Women's Hospital
Ethics committee address [20] 347 0
Ethics committee country [20] 347 0
New Zealand
Date submitted for ethics approval [20] 347 0
Approval date [20] 347 0
Ethics approval number [20] 347 0
Ethics committee name [21] 348 0
Waikato Hospital
Ethics committee address [21] 348 0
Ethics committee country [21] 348 0
New Zealand
Date submitted for ethics approval [21] 348 0
Approval date [21] 348 0
Ethics approval number [21] 348 0
Ethics committee name [22] 349 0
Middlemore Hospital
Ethics committee address [22] 349 0
Ethics committee country [22] 349 0
New Zealand
Date submitted for ethics approval [22] 349 0
Approval date [22] 349 0
Ethics approval number [22] 349 0
Ethics committee name [23] 350 0
Christchurch Women's Hospital
Ethics committee address [23] 350 0
Ethics committee country [23] 350 0
New Zealand
Date submitted for ethics approval [23] 350 0
Approval date [23] 350 0
Ethics approval number [23] 350 0
Ethics committee name [24] 351 0
Women's and Children's
Ethics committee address [24] 351 0
Ethics committee country [24] 351 0
Australia
Date submitted for ethics approval [24] 351 0
Approval date [24] 351 0
11/03/2004
Ethics approval number [24] 351 0
1520/12/2006
Ethics committee name [25] 352 0
Royal Women's
Ethics committee address [25] 352 0
Ethics committee country [25] 352 0
Australia
Date submitted for ethics approval [25] 352 0
Approval date [25] 352 0
17/12/2003
Ethics approval number [25] 352 0
2003000726

Summary
Brief summary
This trial will test if intravenous immunoglobulin (IVIG) reduces death and disability in up to 5000 babies with suspected serious infection in the UK, Europe, Argentina, Australia and New Zealand. Newborn babies are deficient in immunoglobulins (physiological deficiency), especially if they are premature. Babies with severe infection after birth carry a high risk of death or life-long disability, even with appropriate antibiotics. IVIG is concentrated from plasma carefully screened blood donors and is one of the safest blood products available. Earlier trials suggest IVIG may reduce death rates in newborn infants, but did not report disability rates in survivors. Participants, Trialists at the coordinating centre, and clinical professionals involved in the care of the child are blinded to the study treatment. Only the pharmacist and lead statistician are aware of the treatment allocation.
Trial website
Trial related presentations / publications
Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med. 2011 Sep 29;365(13):1201-11.
Public notes

Contacts
Principal investigator
Name 35709 0
Prof William Tarnow Mordi
Address 35709 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 35709 0
Australia
Phone 35709 0
+61 2 9562 5000
Fax 35709 0
Email 35709 0
[email protected]
Contact person for public queries
Name 10294 0
Prof William Tarnow-Mordi
Address 10294 0
Locked Bag 77
Camperdown NSW 1450
Country 10294 0
Australia
Phone 10294 0
6129562 5000
Fax 10294 0
61295651863
Email 10294 0
[email protected]
Contact person for scientific queries
Name 1222 0
Prof. Tarnow-Mordi
Address 1222 0
c/o Locked Bag 77
Camperdown NSW 1450
Country 1222 0
Australia
Phone 1222 0
612 9562 5335
Fax 1222 0
612 9565 1863
Email 1222 0
[email protected]

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No Supporting Document Provided



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