Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000676011
Ethics application status
Approved
Date submitted
13/08/2010
Date registered
17/08/2010
Date last updated
17/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationship between prematurity, kidney volume and retinal micro vasculature among premature babies born in North Queensland
Scientific title
Relationship between prematurity, kidney volume and retinal micro vasculature
Secondary ID [1] 252437 0
None
Universal Trial Number (UTN)
U1111-1116-5143
Trial acronym
PremBNQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premature babies 257949 0
Prematurity and its effect on kidney growth and retinal vasculature development. 257955 0
Condition category
Condition code
Renal and Urogenital 258117 258117 0 0
Normal development and function of male and female renal and urogenital system
Eye 258118 258118 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 258122 258122 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Premature babies will undergo ultrasound kidneys, eye examination ,blood test for renal function and urine analysis twice ( at 32 weeks corrected age and a at 38 weeks corrected age). The investigations will take approximately 1 hour on each occasion. The total duration of the study is for 24 months
Intervention code [1] 257007 0
Not applicable
Comparator / control treatment
A group of term babies ( born after 37 completed weeks) will undergo ultrasound kidneys, eye examination ,blood test for renal function and urine analysis as premature baby but only once . The testing will be done in the first week of life and the duration all the tests would be approximately 1 hour.The total duration of the study is for 24 months
Control group
Active

Outcomes
Primary outcome [1] 258980 0
Kidney volume will be calculated by measuring the width, thickness and length of the kidney. The estimated glomerular filtration rate (eGFR ) would be calculated using serum creatinine and Cystatin C levels.
Timepoint [1] 258980 0
at 38 weeks corrected age
Secondary outcome [1] 265172 0
Retinal vessels thickess and tortuosity would be measured using semi-automated software (Computer-Aided Image Analysis of the Retina (CAIAR)).
Timepoint [1] 265172 0
at 38 weeks corrected age

Eligibility
Key inclusion criteria
Premature babies less than 32 weeks of gestation with parental consent would be recruited into this study.
Minimum age
No limit
Maximum age
42 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Babies with congenital renal, eye and chromosomal abnormalities will be excluded from this study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257456 0
Hospital
Name [1] 257456 0
Townsville Hospital Private Practice and Research Grant
Country [1] 257456 0
Australia
Primary sponsor type
Individual
Name
Dr Yogavijayan Kandasamy
Address
Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country
Australia
Secondary sponsor category [1] 256686 0
None
Name [1] 256686 0
Address [1] 256686 0
Country [1] 256686 0
Other collaborator category [1] 251438 0
Individual
Name [1] 251438 0
Prof Dr Roger Smith
Address [1] 251438 0
Mothers and Babies Research Centre
John Hunter Hospital
Locked Bag 1, Hunter Region Mail Centre,
Newcastle, NSW 2310
Country [1] 251438 0
Australia
Other collaborator category [2] 251447 0
Individual
Name [2] 251447 0
Dr Ian Wright
Address [2] 251447 0
Mothers and Babies Research Centre
John Hunter Hospital
Locked Bag 1, Hunter Region Mail Centre,
Newcastle, NSW 2310
Country [2] 251447 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259480 0
Townsville Health District Human Research Ethics Committee
Ethics committee address [1] 259480 0
100 Angus Smith Drive
Douglas ,Qld 4814
Ethics committee country [1] 259480 0
Australia
Date submitted for ethics approval [1] 259480 0
Approval date [1] 259480 0
11/05/2010
Ethics approval number [1] 259480 0
HREC/10/QTHS/52

Summary
Brief summary
The main focus of this study is to look at the effect of prematurity on kidney growth and function . Kidney size and function in a cohort premature babies (< 32 weeks) is compared with control group (term babies).The study also looks at the rate of kidney growth when a baby is born premature .It will also determine if retinal vasculature ( arterial/venous diameter and branching angles) has correlation to kidney size , kidney function , baby's sex and ethnicity. Most literature says that the foetal retinal matures by 36 to 37 weeks gestation . Baby with significant Retiopathy of prematurity (ROP) will be excluded from analysis .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31520 0
Address 31520 0
Country 31520 0
Phone 31520 0
Fax 31520 0
Email 31520 0
Contact person for public queries
Name 14767 0
Dr Yogavijayan Kandasamy
Address 14767 0
Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 14767 0
Australia
Phone 14767 0
61747961111
Fax 14767 0
61747962981
Email 14767 0
Yoga_Kandasamy@health.qld.gov.au
Contact person for scientific queries
Name 5695 0
Dr Yogavijayan Kandasamy
Address 5695 0
Townsville Hospital
100 Angus Smith Drive
Douglas
QLD 4814
Country 5695 0
Australia
Phone 5695 0
61747961111
Fax 5695 0
61747962981
Email 5695 0
Yoga_Kandasamy@health.qld.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
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