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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 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]

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

Mental health in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986

Educational achievement in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986

Social functioning in young adulthood of individuals who were born with very low birthweight (birthweight less than 1500g) in 1986

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Cardiovascular

Other cardiovascular diseases

Mental Health

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]

Not applicable

Comparator / control treatment

Individuals born at full term in New Zealand in 1986

Control group

Active

Outcomes

Primary outcome [1]

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]

Assessments undertaken once at 26 to 30 years of age

Secondary outcome [1]

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]

Assessments undertaken once at 26 to 30 years of age

Secondary outcome [2]

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]

Assessments undertaken once at 26 to 30 years of age

Secondary outcome [3]

Rates of macro- and micro-structural abnormalities on cranial MRI scans

Timepoint [3]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council of New Zealand

Address [1]

PO Box 5541,
Wellesley St,
Auckland 1141

Country [1]

New Zealand

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Cure Kids

Address [2]

PO Box 90 907,
Victoria Street West,
Auckland 1142

Country [2]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

PO Box 56,
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Canterbury

Address [1]

Private Bag 4800,
Christchurch 8140

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

upper South B regional Ethics Committee

Ethics committee address [1]

C/- Ministry of Health,
PO Box 3877,
Christchurch 8024

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

14/05/2012

Ethics approval number [1]

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

Dr Sarah Harris

Address

Department of Paediatrics
University of Otago Christchurch
PO Box 4345
Christchurch 8140
New Zealand

Country

New Zealand

Phone

+64 3 3726718

Fax

sarah.harris@otago.ac.nz

Contact person for public queries

Name

Bridget Kinnersley

Address

Department of Psychological Medicine, University of Otago, Christchurch
PO Box 4345, Christchurch 8140, New Zealand

Country

New Zealand

Phone

+64 3 3726706

Fax

bridget.kinnersley@otago.ac.nz

Contact person for scientific queries

Name

Sarah Harris

Address

Department of Paediatrics,
University of Otago Christchurch,
PO Box 4345,
Christchurch 8140

Country

New Zealand

Phone

+64 3 372 6718

Fax

sarah.harris@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No consent for this

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13828	Study protocol	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

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The New Zealand 1986 very low birth weight cohort as young adults: Mapping the road ahead.	2015	https://dx.doi.org/10.1186/s12887-015-0413-9
Embase	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.	2018	https://dx.doi.org/10.1136/bjophthalmol-2017-311345
Embase	Metabolic Syndrome in Very Low Birth Weight Young Adults and Controls: The New Zealand 1986 VLBW Study.	2019	https://dx.doi.org/10.1016/j.jpeds.2018.10.060
Embase	Cardiovascular Outcomes in Young Adulthood in a Population-Based Very Low Birth Weight Cohort.	2020	https://dx.doi.org/10.1016/j.jpeds.2020.06.023
Embase	Biomarkers of ageing in New Zealand VLBW young adults and controls.	2021	https://dx.doi.org/10.1038/s41390-020-0882-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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