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Trial registered on ANZCTR


Registration number
ACTRN12612000995875
Ethics application status
Approved
Date submitted
5/06/2012
Date registered
17/09/2012
Date last updated
17/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of health and functioning of New Zealand very preterm infants as young adults
Scientific title
Assessment of health and functioning of New Zealand very low birthweight infants born in 1986 as young adults compared with age-matched peers born at term.
Secondary ID [1] 280615 0
Health Research Council of New Zealand reference: 12/139
Universal Trial Number (UTN)
U1111-1131-4703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical health in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986 286628 0
Mental health in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986 287347 0
Educational achievement in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986 287348 0
Social functioning in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986 287349 0
Condition category
Condition code
Reproductive Health and Childbirth 286907 286907 0 0
Complications of newborn
Cardiovascular 286908 286908 0 0
Other cardiovascular diseases
Mental Health 286909 286909 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of growth parameters, total body fat, blood pressure, left ventricular function, endothelial dysfunction, respiratory function, visual function, creatine clearance, fasting insulin and glucose, cognitive and psychological functioning; assessments undertaken over 2 days at 26-27 years of age.
Intervention code [1] 285013 0
Not applicable
Comparator / control treatment
Individuals born at full term in New Zealand in 1986
Control group
Active

Outcomes
Primary outcome [1] 287264 0
Quality of life, assessed by SF-36 Quality of Life Questionnaire, in very low birthweight young adults in comparison to their peers born at term
Timepoint [1] 287264 0
Assessments undertaken once at 26 to 27 years of age
Secondary outcome [1] 297783 0
Measures of cognitive ability (Weschler Adult intelliigence Scale-IV), information processing and executive function (Sternberg Spatial Working Memory Paradigm, Rivermead Behavioural Memory Test, Wisconsin card Sorting Test, Rey-Osterrieth Complex Figure Test).
Timepoint [1] 297783 0
Assessments undertaken once at 26 to 27 years of age
Secondary outcome [2] 297784 0
Rates of cardiovascular (blood pressure, echocardiogram, peripheral artery tonometry), endocrine (fasting insulin and glucose), pulmonary (forced expiratory volumes, static lung volumes, diffusing capacity of CO, single breath nitrogen washout, exercise test), renal (creatine clearance) and visual anbnormalities (distance visual acuity, contrast sensitivity, autorefraction, retinal photographs).
Timepoint [2] 297784 0
Assessments undertaken once at 26 to 27 years of age
Secondary outcome [3] 297785 0
Rates of macro- and micro-structural abnormalities on cranial MRI scans
Timepoint [3] 297785 0
Assessments undertaken once at 26 to 27 years of age

Eligibility
Key inclusion criteria
Cohort group: Born in New Zealand in 1986 with birthweight less than 1500g

Comparator group: Born in New Zealand in 1986 at full term
Minimum age
26 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Comparator group only. Exclusion criteria are not born in New Zealand in 1986 at full term

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4346 0
New Zealand
State/province [1] 4346 0

Funding & Sponsors
Funding source category [1] 285374 0
Government body
Name [1] 285374 0
Health Research Council of New Zealand
Address [1] 285374 0
PO Box 5541,
Wellesley St,
Auckland 1141
Country [1] 285374 0
New Zealand
Funding source category [2] 285375 0
Charities/Societies/Foundations
Name [2] 285375 0
Cure Kids
Address [2] 285375 0
PO Box 90 907,
Victoria Street West,
Auckland 1142
Country [2] 285375 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56,
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284234 0
None
Name [1] 284234 0
Address [1] 284234 0
Country [1] 284234 0
Other collaborator category [1] 276842 0
University
Name [1] 276842 0
University of Canterbury
Address [1] 276842 0
Private Bag 4800,
Christchurch 8140
Country [1] 276842 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287391 0
upper South B regional Ethics Committee
Ethics committee address [1] 287391 0
C/- Ministry of Health,
PO Box 3877,
Christchurch 8024
Ethics committee country [1] 287391 0
New Zealand
Date submitted for ethics approval [1] 287391 0
Approval date [1] 287391 0
14/05/2012
Ethics approval number [1] 287391 0
URB/12/05/015

Summary
Brief summary
We aim to assess the health and functional outcomes at 26-27 years of a large cohort of New Zealand babies born with very low birthweight (<1500g) in1986 and included in a prospective study. Very low birthweight babies account for nearly 2% of all births but 75% of neonatal intensive care unit workload. Although no NZ data exist, overseas studies suggest such young adults have increased risks of physical and health problems, educational underachievement and poorer social functioning than their peers. The group was last assessed at age 7- 8 years. We have now retraced 250 young adult survivors (77% of the group) and will bring them to Christchurch for two days of medical and psychological evaluations. A comparison group of 100 full term adults of the same age will also be assessed. Findings will inform health, education and social policies concerning very preterm survivors as well as future newborn care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34264 0
Address 34264 0
Country 34264 0
Phone 34264 0
Fax 34264 0
Email 34264 0
Contact person for public queries
Name 17511 0
Professor Brian Darlow
Address 17511 0
Department of Paediatrics,
University of Otago Christchurch,
PO Box 4345,
Christchurch 8140
Country 17511 0
New Zealand
Phone 17511 0
+64 3 3640747
Fax 17511 0
Email 17511 0
brian.darlow@otago.ac.nz
Contact person for scientific queries
Name 8439 0
Professor Brian Darlow
Address 8439 0
Department of Paediatrics,
University of Otago Christchurch,
PO Box 4345,
Christchurch 8140
Country 8439 0
New Zealand
Phone 8439 0
+64 3 3640747
Fax 8439 0
Email 8439 0
brian.darlow@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results