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Trial registered on ANZCTR

Registration number

ACTRN12618000871246

Ethics application status

Approved

Date submitted

11/05/2018

Date registered

22/05/2018

Date last updated

10/05/2021

Date data sharing statement initially provided

23/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Understanding Creatine for Neurological Health in Babies

Scientific title

Circulating and Cerebral Creatine Levels of the Preterm Infant: Implications for Neurological Development.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

UNICORN Babies

Linked study record

Health condition

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

Preterm Birth

Condition category

Condition code

Neurological

Other neurological disorders

Diet and Nutrition

Other diet and nutrition disorders

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Observations [1] Measurement of creatine and associated metabolites in plasma, urine and nutrition samples, collected from preterm babies across the duration of their stay within the NICU; [2] MRI/MRS scan at term equivalent age; [3] Developmental follow up assessment at three months term corrected age.

Intervention code [1]

Diagnosis / Prognosis

Intervention code [2]

Early Detection / Screening

Comparator / control treatment

healthy singleton babies born at term (39-40 weeks gestation)

Control group

Active

Outcomes

Primary outcome [1]

Infant creatine levels (composite outcome of plasma, urinary and cerebral measures) at term corrected age. Plasma and urine creatine will be measured using LC-MS, and cerebral creatine measured from an MRI/MRS scan.

Timepoint [1]

Term corrected age

Secondary outcome [1]

Creatine content of diet (TPN, formula or breastmilk) received by infants during their stay in hospital, measured using LC-MS.

Timepoint [1]

term corrected age.

Secondary outcome [2]

Neurological outcomes of infants up to 3 month of age. Composite measures of MRI scans, general movements assessment and the DAYC-2 developmental assessment tool.

Timepoint [2]

Term corrected age and 3 months of term corrected age.

Eligibility

Key inclusion criteria

1. Singleton babies
2. Provision of Signed and Dated Informed Consent from Parent/Guardian
3. Preterm infants of gestational post maternal age receiving care within the Neonatal Intensive Care Unit at CCDHB, or, healthy term infants at 39-40 weeks gestation from low risk pregnancies delivered at CCDHB.

Minimum age

23 Weeks

Maximum age

40 Weeks

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Babies with major congenital, genetic or chromosomal abnormalities known to affect neurodevelopmental outcomes
2. Hypoxic ischaemic encephalopathy
3. Inborn (proven or suspected) errors of metabolism
4. Fetal growth restriction (birth weight <10th percentile on customised percentiles)

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

28/05/2018

Actual

13/08/2018

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

31/08/2021

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cerebral Palsy Alliance

Address [1]

187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086

Country [1]

Australia

Primary sponsor type

University

Name

Hudson Institute of Medical Research/Monash University

Address

27-31 Wright Street, Clayton, Victoria 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/01/2018

Approval date [1]

26/04/2018

Ethics approval number [1]

18/CEN/17

Summary

Brief summary

Each year around 10% of all babies born in Australia and New Zealand are preterm. Over half of these babies will have acquired brain injury, increasing their risks of developing life-long conditions, such as cerebral palsy. Creatine and its phosphorylated derivative phosphocreatine (PCr) have long been established as having a critical role in neural development and brain metabolism, with creatine deficiency syndromes leading to significant neurological impairments, including mental retardation, expressive speech and language delay, autistic like behaviour and epilepsy. We have evidence from preclinical animal studies to suggest that preterm babies will be creatine deficient due to an immature renal-hepatic axis and inability to make creatine. Our preliminary data from a 26-week preterm infant shows a dramatic fall in plasma creatine concentration over the first week of life, suggesting this baby was unable to maintain creatine homeostasis. These observations taken together raise questions about whether creatine insufficiency predisposes or compounds neurological deficits in preterm infants?

We will utilise non-invasive imaging techniques to measure cerebral creatine levels in preterm infants, to determine any creatine deficiencies in this population. The innovation of this work is that early detection of cerebral creatine deficiency in preterm infants will provide the basis of early intervention with creatine supplementation to avoid cerebral energy deficiency and the ensuing development of poor neurological sequela associated with these deficiencies. If our hypothesis is proven, we stand to revolutinise the nutritional care of preterm infants, directly influence brain function and improve the short and long-term neurological outcomes for these babies.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Max Berry

Address

Department of Paediatrics and Child Health, University of Otago Wellington
23A Mein Street
Wellington, New Zealand 6242

Country

New Zealand

Phone

+64 212449929

Fax

[email protected]

Contact person for public queries

Name

Max Berry

Address

Department of Paediatrics and Child Health, University of Otago Wellington
23A Mein Street
Wellington, New Zealand 6242

Country

New Zealand

Phone

+64 212449929

Fax

[email protected]

Contact person for scientific queries

Name

Stacey Ellery

Address

Hudson Institute of Medical Research
27-31 Wright Street, Clayton, Victoria 3168

Country

Australia

Phone

+61 385722870

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4200	Study protocol	Berry, Mary J., et al. "UNICORN Babies: Understanding Circulating and Cerebral Creatine Levels of the Preterm Infant. An Observational Study Protocol." Frontiers in physiology 10 (2019).	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6417365/			375080-(Uploaded-20-08-2019-16-25-20)-Study-related document.pdf

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	Unicorn babies: Understanding circulating and cerebral creatine levels of the preterm infant. An observational study protocol.	2019	https://dx.doi.org/10.3389/fphys.2019.00142

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

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