Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000852358
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
8/06/2017
Date last updated
8/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Near-Infrared spectroscopy for Monitoring brain Oxygenation in Premature infants
Scientific title
Cerebral regional oxygenation and neurological outcomes in premature infants
Secondary ID [1] 292050 0
None
Universal Trial Number (UTN)
U1111-1196-8545
Trial acronym
NIMO-Prem
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral regional oxygenation 303454 0
Prematurity 303484 0
Condition category
Condition code
Neurological 302864 302864 0 0
Other neurological disorders
Reproductive Health and Childbirth 302898 302898 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Informed parental consent will be obtained in all cases prior to data collection. Once the parental consent is obtained, following data will be collected as part of the study.

Continuous physiological measurement during the first 72hrs:

1. Cerebral regional oxygenation (using INVOSTM 5100c/ OXYALERTTM NIRSensor Infant/Neonatal)
2. Arterial blood pressure*
3. End-tidal CO2*
4. Peripheral arterial saturation*

* These physiological measurements are part of routine clinical care in this cohort of patients.

Non-continuous investigations:
1. Urinary biomarkers of hypoxic/ischaemic brain injury (urine will be collected non-invasively)
2. Brain perfusion pressure (Middle Cerebral Artery Blood Flow Velocity) using Doppler ultrasound
3. Cranial ultrasound scan (CUSS)**
4. Cardiac echocardiography**
5. MRI brain at term-equivalent age
6. Bayley Infants Neurodevelopmental Scales**

** These investigations are part of routine clinical care in this cohort of patients. However, additional CUSS may be performed for the purpose of the study.

Patient characteristics:
The following demographic and clinical information will be gathered as part of the study

1. Maternal demographics
2. Relevant maternal past medical, antenatal and perinatal history
3. Infant’s perinatal and postnatal history
Intervention code [1] 298181 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302257 0
White matter injury on MRI brain
Timepoint [1] 302257 0
Term-equivalent age (TEA)
Secondary outcome [1] 335305 0
Intraventricular haemorrhage (IVH) / periventricular leucomalacia (PVL) seen in cranial ultrasound scan
Timepoint [1] 335305 0
Day 1, day 2, day 3, 1 week and 1 month of age
Secondary outcome [2] 335306 0
Urinary biomarkers of hypoxic/ischaemic brain injury (S100B and Activin A ELISA tests)
Timepoint [2] 335306 0
Day 1, day 2 and day 3 of life
Secondary outcome [3] 335307 0
Bayley Infant Neurodevelopment Scales
Timepoint [3] 335307 0
One assessment to be performed at approximately 18 months of age (if a formal neurodevelopmental assessment is performed as part of clinical care between 12-24 months of age then the results from this assessment will be used instead)

Eligibility
Key inclusion criteria
Preterm infants (<30 weeks gestation) with extremely low birth weight (<1000g) who are born in Wellington Regional Hospital
Minimum age
No limit
Maximum age
4 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Complex congenital abnormalities
2. Known genetic abnormalities
3. Poor skin integrity
4. Significant hydrops fetalis
5. Palliation due to extreme condition at birth

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
POWER ANALYSIS: Using the Receiver Operating Characteristics (ROC) curve a sample size of 120 infants will be required to detect 12% difference with the Area Under the Curve (AUC) of 0.75.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/06/2017
Actual
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 8930 0
New Zealand
State/province [1] 8930 0
Wellington

Funding & Sponsors
Funding source category [1] 296586 0
University
Name [1] 296586 0
University of Otago, Wellington
Country [1] 296586 0
New Zealand
Primary sponsor type
Individual
Name
Dr Maria Saito-Benz
Address
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown 6021
Wellington
Country
New Zealand
Secondary sponsor category [1] 295538 0
Government body
Name [1] 295538 0
Capital and Coast District Health Board
Address [1] 295538 0
Clinical Trials Unit
Wellington Regional Hospital
Riddiford street
Newtown
Wellington 6021
Country [1] 295538 0
New Zealand
Other collaborator category [1] 279586 0
Individual
Name [1] 279586 0
Dr Max Berry
Address [1] 279586 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown 6021
Wellington
Country [1] 279586 0
New Zealand
Other collaborator category [2] 279587 0
Individual
Name [2] 279587 0
A/Prof Shieak Tzeng
Address [2] 279587 0
Centre for Translational Physiology
University of Otago, Wellington
23A Mein Street
Newtown 6021
Wellington
Country [2] 279587 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297807 0
Health and Disability Ethics Committee
Ethics committee address [1] 297807 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 297807 0
New Zealand
Date submitted for ethics approval [1] 297807 0
16/11/2016
Approval date [1] 297807 0
29/03/2017
Ethics approval number [1] 297807 0
16/NTA/209

Summary
Brief summary
One in 12 babies in New Zealand are born premature. Premature infants, especially those born less than 30 weeks gestation and/or extremely low birth weight (<1000g), carry a disproportionate burden of mortality and lifelong neurodevelopmental disability when compared to their healthy term­born peers.

For healthy brain development ensuring adequate supply of oxygenated blood to the brain is critical; however, what constitutes the 'optimal' brain perfusion and oxygen level in premature infants is currently unknown. In this observational study we will utilise portable and non­invasive equipment and radiological imaging to develop better understanding of the optimal brain perfusion and oxygenation targets to prevent mortality and later neurodevelopmental disability.

Of note, NIMO­Prem is the New Zealand component of a two­centre international collaborative study (the other centre being Texas Children's Hospital, USA). This study protocol is only applicable to the local study based in Wellington Regional Hospital, Wellington NZ.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1752 1752 0 0
/AnzctrAttachments/373024-NIMO-Prem protocol .pdf (Protocol)
Attachments [2] 1753 1753 0 0
/AnzctrAttachments/373024-NIMO-Prem PIS .pdf (Participant information/consent)
Attachments [3] 1754 1754 0 0
/AnzctrAttachments/373024-Consent Form NIMO-Prem (amendment v1).pdf (Participant information/consent)
Attachments [4] 1755 1755 0 0
/AnzctrAttachments/373024-HDEC Letter 16NTA209_Approved FULL Application.pdf (Ethics approval)
Attachments [5] 1756 1756 0 0
/AnzctrAttachments/373024-Locality approval.pdf (Supplementary information)

Contacts
Principal investigator
Name 75154 0
Dr Maria Saito-Benz
Address 75154 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 75154 0
New Zealand
Phone 75154 0
+64 21 570 609
Fax 75154 0
Email 75154 0
[email protected]
Contact person for public queries
Name 75155 0
Ms Jenny Jeffrey
Address 75155 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 75155 0
New Zealand
Phone 75155 0
+64 4 918 6138
Fax 75155 0
Email 75155 0
[email protected]
Contact person for scientific queries
Name 75156 0
Dr Maria Saito-Benz
Address 75156 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 75156 0
New Zealand
Phone 75156 0
+64 21 570 609
Fax 75156 0
Email 75156 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23529Ethical approval  [email protected] 373024-(Uploaded-05-12-2019-13-01-34)-Study-related document.pdf
23530Study protocol    373024-(Uploaded-05-12-2019-13-04-54)-Study-related document.docx
23531Informed consent form    373024-(Uploaded-05-12-2019-13-07-40)-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
No additional documents have been identified.