Trial Review

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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
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
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 26-30 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 30 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 30 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 30 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 30 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
Sex
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
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
1/11/2016
Date of last data collection
Anticipated
Actual
11/11/2016
Sample size
Target
350
Accrual to date
Final
350
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
Country [1] 285374 0
New Zealand
Funding source category [2] 285375 0
Charities/Societies/Foundations
Name [2] 285375 0
Cure Kids
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 26-30 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
https://www.otago.ac.nz/christchurch/departments/paediatrics/otago040041.html
Trial related presentations / publications
Kajantie E, Johnson S, Heinonen K, Anderson PJ, Wolke D, Evensen KAI, Räikkönen K, Darlow BA, van der Pal S, Indredavik MS, Jaekel J, Hovi P, Morrison K, Verrips E, Doyle LW, APIC Adults Born Preterm International Collaboration. Common core assessments in follow-up studies of adults born preterm – Recommendation of the Adults Born Preterm International Collaboration. Pediatric and Perinatal Epidemiology, 2020. doi: 10.1111/ppe.12694

Darlow BA, Woodward LJ, Levin KJ, Melzer T, Horwood LJ. Perinatal and childhood predictors of general cognitive outcome at 28 years in a very-low-birthweight national cohort. Developmental Medicine & Child Neurology, 2020; 62(12): 1423-1428. doi: 10.1111/dmcn.14649

Darlow BA, Horwood J, Dhakal B, Harris SL, McKelvey VA, Elliott JM, Yang J, Mackay RJ. Biomarkers of ageing in New Zealand VLBW young adults and controls. Pediatric Research, 2020. doi: 10.1038/s41390-020-0882-x

Yang J, Kingsford RA, Horwood J, Epton MJ, Swanney MP, Stanton J, Darlow BA. Lung Function of Adults Born at Very Low Birth Weight. Pediatrics, 2020; 145(2): e20192359. doi: 10.1542/peds.2019-2359

Harris SL, Bray H, Troughton R, Elliott J, Frampton C, Horwood J, Darlow BA. Cardiovascular Outcomes in Young Adulthood in a Population-Based Very Low Birth Weight Cohort. The Journal of Pediatrics, 2020. doi: 10.1016/j.peds.2020.06.023

Darlow BA, Martin J, Horwood LJ. Metabolic syndrome in very low birth weight young adults and controls: the NZ 1986 VLBW study. Journal of Pediatrics, 2019; 206: 128-133.e5. doi: 10.1016/j.jpeds.2018.10.060.

Darlow BA, Martin J, Horwood LJ. Unrecognised and unmet physical health problems in a national cohort of very low birthweight (VLBW) young adults and controls. J Primary Health Care, 2019; 11: 32-8. doi: 10.1071/HC18044

Pascoe MJ, Melzer TR, Horwood LJ, Woodward LJ, Darlow BA. Altered grey matter volume, perfusion and white matter integrity in very low birthweight adults. NeuroImage: Clinical, 2019; 22 :101780. doi: 10.1016/j.nicl.2019.101780

Darlow BA, Elder M, Kimber B, Martin J, Horwood LJ. Vision in former very low birthweight young adults with and without retinopathy of prematurity compared with term born controls: The NZ 1986 VLBW Follow-up Study. British Journal of Ophthalmology, 2018; 102: 1041-6. doi: 10.1136/bjophthalmol-2017-311345

Prickett TCR, Darlow BA, Troughton RW, Cameron VA, Elliott JM, Martin J, Horwood LJ, Espiner EA. New insights into cardiac and vascular natriuretic peptides: Findings from young adults born with very low birth weight. Clinical Chemistry, 2018; 64(2): 363–373. doi: 10.1373/clinchem.2017.280354

Darlow BA, Horwood LJ, Woodward LJ, Elliott JM, Troughton RW, Elder M, Epton M, Stanton J, Swanney M, Keenan R, Melzer T, McKelvey V, Levin K, Meeks MG, Espiner EA, Cameron VA, Martin J. The New Zealand 1986 very low birth weight cohort as young adults: mapping the road ahead. Study protocol. BMC Pediatrics, 2015; 15: 90. doi: 10.1186/s12887-015-0413-9

Darlow BA, Horwood LJ, Pere-Bracken H, Woodward LJ. Psychosocial outcomes of young adults born very low birth weight. Pediatrics, 2013; 132: e1521-1528. doi: 10.1542/peds.2013-2024
Public notes

Contacts
Principal investigator
Name 34264 0
Dr Sarah Harris
Address 34264 0
Department of Paediatrics
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand
Country 34264 0
New Zealand
Phone 34264 0
+64 3 3726718
Fax 34264 0
Email 34264 0
[email protected]
Contact person for public queries
Name 17511 0
Ms Bridget Kinnersley
Address 17511 0
Department of Psychological Medicine, University of Otago, Christchurch
PO Box 4345, Christchurch 8140, New Zealand
Country 17511 0
New Zealand
Phone 17511 0
+64 3 3726706
Fax 17511 0
Email 17511 0
[email protected]
Contact person for scientific queries
Name 8439 0
Dr Sarah Harris
Address 8439 0
Department of Paediatrics,
University of Otago Christchurch,
PO Box 4345,
Christchurch 8140
Country 8439 0
New Zealand
Phone 8439 0
+64 3 372 6718
Fax 8439 0
Email 8439 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No consent for this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13828Study protocolDarlow BA, Horwood LJ, Woodward LJ, Elliott JM, Troughton RW, Elder M, Epton M, Stanton J, Swanney M, Keenan R, Melzer T, McKelvey V, Levin K, Meeks MG, Espiner EA, Cameron VA, Martin J. The New Zealand 1986 very low birth weight cohort as young adults: mapping the road ahead. Study protocol. BMC Pediatrics, 2015; 15: 90. doi: 10.1186/s12887-015-0413-9  



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Prickett TCR, Darlow BA, Troughton RW, Cameron VA,... [More Details]
Study results articleYes Darlow BA, Elder M, Kimber B, Martin J, Horwood LJ... [More Details]
Study results articleYes Pascoe MJ, Melzer TR, Horwood LJ, Woodward LJ, Dar... [More Details]
Study results articleYes Darlow BA, Martin J, Horwood LJ. Unrecognised and ... [More Details]
Study results articleYes Darlow BA, Martin J, Horwood LJ. Metabolic syndrom... [More Details]
Study results articleYes Harris SL, Bray H, Troughton R, Elliott J, Frampto... [More Details]
Study results articleYes Yang J, Kingsford RA, Horwood J, Epton MJ, Swanney... [More Details]
Study results articleYes Darlow BA, Horwood J, Dhakal B, Harris SL, McKelve... [More Details]
Study results articleYes Darlow BA, Woodward LJ, Levin KJ, Melzer T, Horwoo... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMetabolic Syndrome in Very Low Birth Weight Young Adults and Controls: The New Zealand 1986 VLBW Study.2019https://dx.doi.org/10.1016/j.jpeds.2018.10.060
EmbaseCardiovascular Outcomes in Young Adulthood in a Population-Based Very Low Birth Weight Cohort.2020https://dx.doi.org/10.1016/j.jpeds.2020.06.023
EmbaseBiomarkers of ageing in New Zealand VLBW young adults and controls.2021https://dx.doi.org/10.1038/s41390-020-0882-x
EmbaseThe New Zealand 1986 very low birth weight cohort as young adults: Mapping the road ahead.2015https://dx.doi.org/10.1186/s12887-015-0413-9
EmbaseVision in former very low birthweight young adults with and without retinopathy of prematurity compared with term born controls: The NZ 1986 VLBW follow-up study.2018https://dx.doi.org/10.1136/bjophthalmol-2017-311345
N.B. These documents automatically identified may not have been verified by the study sponsor.