ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000327583

Ethics application status

Approved

Date submitted

27/03/2003

Date registered

27/03/2003

Date last updated

12/05/2023

Date data sharing statement initially provided

23/11/2022

Date results provided

23/11/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

The DINO Trial

Scientific title

Docosahexaenoic Acid (DHA) for the Improvement of Neurodevelopmental Outcome in Preterm Infants.

Secondary ID [1]

Perinatal Trials Registry: PTR424

Universal Trial Number (UTN)

Trial acronym

DINO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preterm Infants < or = 32 weeks

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. High - DHA feeding practice: mothers diet supplemented with tuna oil capsules 6x 500mg DHA rich tuna oil capsules per day to increase DHA in breast milk. If formula is required a high DHA commercial preterm formula is used.
The intervention will commence within 5 days of the preterm infant commencing enteral feeds and continue until the expected term date (40 weeks post menstrual age).
Follow up will occur at 4, 12 and 18 months corrected age.

Intervention code [1]

Other interventions

Comparator / control treatment

2. Standard infant feeding practice. Mothers take 6x500mg placebo soy oil capsules or standard preterm infant formula.

Control group

Placebo

Outcomes

Primary outcome [1]

Neurodevelopment assessed with the Bayleys Scales of Infant Development (II).

Timepoint [1]

At 18 months corrected age

Primary outcome [2]

The primary outcome for the follow-up study at seven years' corrected age is general intellectual ability (Full Scale IQ) as estimated with the Wechsler Abbreviated Scale of Intelligence (WASI).

Timepoint [2]

Seven years' corrected age

Secondary outcome [1]

Growth

Timepoint [1]

Will be measured weekly from enrolment until estimated date of delivery (EDD) and then at 4, 12 and 18 months corrected age.

Secondary outcome [2]

Safety

Timepoint [2]

Markers of safety, such as episodes of necrotising enterocolitis and days to reach full enteral feeds will be collected and assessed.

Secondary outcome [3]

Secondary outcomes include cognitive function, educational progress, behaviour, quality of life, symptoms of asthma and allergy, anthropometrics and blood pressure.

Timepoint [3]

Seven years' corrected age

Eligibility

Key inclusion criteria

1. Infants born < or = 32 weeks gestation 2. Signed written informed consent 3. Family/guardians who speak English

Minimum age

No limit

Maximum age

32 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Infants with major congenital or chromosomal abnormalities 2. More than 5 days after commencing enteral feeds 3. Lactating mother with blood clotting disorder where tuna oil is contraindicated or regularly taking anticoagulant therapy 4. Participation in other clinical trials involving fatty acid intervention 5. Geographic location 6. Multiple births where not all live born infants are eligible.

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)

Centralised telephone randomisation service

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated randomisation schedule with balanced variable blocks, stratified by study site, gender and birthweight.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/12/2003

Actual

4/04/2001

Date of last participant enrolment

Anticipated

Actual

28/10/2005

Date of last data collection

Anticipated

Actual

10/07/2013

Sample size

Target

640

Accrual to date

Final

657

Recruitment in Australia

Recruitment state(s)

QLD,SA,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health & Medical Research Council

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

National Health and Medical Research Council

Address

GPO Box 1421 Canberra ACT 2601

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children Yout and Women's Health Service

Ethics committee address [1]

72 King William Rd, North Adelaide South Australia 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/05/2002

Ethics approval number [1]

REC973/4/2005

Ethics committee name [2]

Flinders Medical Centre

Ethics committee address [2]

Flinders Dr, Bedford Park South Australia 5042

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

09/05/2002

Ethics approval number [2]

122/023

Ethics committee name [3]

King Edward Memorial Hospital

Ethics committee address [3]

374 Bagot Rd, Subiaco Western Australia 6008

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

30/05/2003

Ethics approval number [3]

EC03-21.4

Ethics committee name [4]

Royal Women's Hospital

Ethics committee address [4]

20 Flemington Rd, Parkville Victoria 3052

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

10/06/2003

Ethics approval number [4]

03/16

Ethics committee name [5]

Royal Brisbane and Women's Hospita

Ethics committee address [5]

Butterfield St, Herston Queensland 4029

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

22/09/2003

Ethics approval number [5]

RWH03/16

Summary

Brief summary

Docosahexaenoic Acid (DHA) is a long chain omega 3 polyunsaturated fatty acid which is important for growth and development. DHA also plays an essential role in the development of the central nervous system and retinal function in infants. Preterm infants are denied the large amount of DHA which is normally delivered via the placenta in the last trimester of pregnancy. The DINO trial is a multi-centre, randomized controlled trial to determine whether increasing the level of DHA in breast milk will improve the developmental outcome of preterm infants who are born less than 32 weeks gestation. Study participants, clinicians and trial personnel will be blinded to treatment allocation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Maria Makrides

Address

Women's and Children's Health Research Institute
72 King William Road
North Adelaide SA 5006

Country

Australia

Phone

+61 8 8161 6179

Fax

+61 8 8239 0267

[email protected]

Contact person for public queries

Name

Thomas Sullivan

Address

South Australian Health & Medical Research Institute,
72 King William St, Adelaide SA 5000

Country

Australia

Phone

+61 8 8128 4419

Fax

[email protected]

Contact person for scientific queries

Name

Thomas Sullivan

Address

South Australian Health & Medical Research Institute,
72 King William St, Adelaide SA 5000

Country

Australia

Phone

+61 8 8128 4419

Fax

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

De-identified, individual participant data (IPD) that underlie the results reported in the primary paper (text, tables, figures and appendices) will be available. Dataset(s) will be limited to those participants and variables that are necessary for completion of the approved research proposal

When will data be available (start and end dates)?

Available after publication with no end date determined

Available to whom?

Data will be available to researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement

Available for what types of analyses?

Data may be shared with researchers who provide a methodologically sound research proposal following review and approval by the trial steering committee and completion of a signed data access agreement

How or where can data be obtained?

All data requests should be made to [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
17687	Study protocol	[email protected]
17688	Statistical analysis plan	[email protected]
17689	Other	[email protected]	Case report form

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
Dimensions AI	Maternal supplementation with docosahexaenoic acid during pregnancy does not affect early visual development in the infant: a randomized controlled trial	2011	https://doi.org/10.3945/ajcn.110.009647
Embase	Neurodevelopmental outcomes at 7 years' corrected age in preterm infants who were fed high-dose docosahexaenoic acid to term equivalent: A follow-up of a randomised controlled trial.	2015	https://dx.doi.org/10.1136/bmjopen-2014-007314
Embase	Long-term effect of high-dose supplementation with DHA on visual function at school age in children born at < 33 wk gestational age: Results from a follow-up of a randomized controlled trial.	2016	https://dx.doi.org/10.3945/ajcn.115.114710
Embase	Docosahexaenoic acid supplementation of preterm infants and parent-reported symptoms of allergic disease at 7 years corrected age: Follow-up of a randomized controlled trial.	2019	https://dx.doi.org/10.1093/ajcn/nqz010
Embase	Consequences of using chronological age versus corrected age when testing cognitive and motor development in infancy and intelligence quotient at school age for children born preterm.	2021	https://dx.doi.org/10.1371/journal.pone.0256824
Embase	Subgroup analyses of a randomized trial of DHA supplementation for infants born preterm with assessments of cognitive development up to 7-years of age: What happens in infants born <29 weeks' gestation?.	2023	https://dx.doi.org/10.1016/j.plefa.2023.102593

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

Trial Review

Documents added manually

Documents added automatically