Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001581358
Ethics application status
Approved
Date submitted
13/11/2017
Date registered
27/11/2017
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Date results information initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Near Infrared spectroscopy for Monitoring brain Oxygenation: a single-centre randomised controlled trial of freshly irradiated versus standard red cell transfusion for treatment of anaemia of prematurity (NIMO-Rad)
Scientific title
Near Infrared spectroscopy for Monitoring brain Oxygenation: a single-centre single-blind randomised controlled trial of freshly irradiated versus standard red cell transfusion for treatment of anaemia of prematurity
Secondary ID [1] 293331 0
None
Universal Trial Number (UTN)
U1111-1204-9305
Trial acronym
NIMO-Rad
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia of Prematurity 305422 0
Cerebral oxygenation 305423 0
Condition category
Condition code
Blood 304702 304702 0 0
Anaemia
Reproductive Health and Childbirth 304762 304762 0 0
Complications of newborn
Neurological 304763 304763 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants randomised to the intervention arm will receive 15ml/kg of appropriately cross-matched, leucoreduced red blood cells from cytomegalovirus-negative donor, irradiated on the day of blood transfusion ('freshly irradiated red blood cells') in Wellington Neonatal Intensive Care Unit (NICU). Transfusion will be given through a cannula inserted by a qualified doctor working in Wellington NICU, and will be administered over 3hours by the registered nurse looking after the participating infant on the day of study transfusion.
Intervention code [1] 299600 0
Treatment: Other
Comparator / control treatment
Infants randomised to the control arm will receive 15ml/kg of appropriately cross-matched, leucoreduced red blood cells from cytomegalovirus-negative donor, irradiated and stored for up to 14 days (as per the current ANZSBT guidelines) in Wellington NICU. Transfusion will be given through a cannula inserted by a qualified doctor working in Wellington NICU, and will be administered over 3hours by the registered nurse looking after the participating infant on the day of study transfusion.
Control group
Active

Outcomes
Primary outcome [1] 303931 0
Cerebral regional oxygenation (crSO2, %), measured using Near Infrared Spectroscopy (NONIN SenSmart X-100).
Timepoint [1] 303931 0
Immediately (primary end-point), 1 day and 5 days after transfusion
Secondary outcome [1] 340480 0
Fractional tissue oxygen extraction (FTOE), measured using Near Infrared Spectroscopy and Pulse Oximetry (NONIN SenSmart X-100)
Timepoint [1] 340480 0
Immediately, 1 day and 5 days after transfusion

Eligibility
Key inclusion criteria
Preterm infants (<34 weeks gestation) who are receiving non-urgent transfusion of red blood cells for Anaemia of Prematurity in Wellington Neonatal Intensive Care Unit
Minimum age
14 Days
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Urgent transfusion is required
2. Mechanically ventilated at the time of transfusion
3. Undergoing treatment for systemic infections
4. Receiving medical treatment, or awaiting surgery, for haemodynamically significant patent ductus arteriosus.
5. Undergoing any other planned surgical intervention within 5 days of the blood transfusion episode to be studied
6. Significantly oedematous

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)
Allocation is done in the Blood Bank (away from NICU study site), and the outcome of allocation is concealed from the study investigators, participants, and medical/nursing staff looking after the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation sequence was generated using www.sealedenvelope.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the post-hoc analysis from a recent study completed (NIMO-AI), a sample size of at least 60 infants is required to detect a difference of 5% in cerebral tissue oxygenation immediately after transfusion between the intervention and control groups, with power of 0.96 and p-value of 0.05 (t-test, G power 3.1)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2017
Actual
4/12/2017
Date of last participant enrolment
Anticipated
31/08/2018
Actual
1/11/2018
Date of last data collection
Anticipated
5/09/2018
Actual
6/11/2018
Sample size
Target
60
Accrual to date
Final
64
Recruitment outside Australia
Country [1] 9352 0
New Zealand
State/province [1] 9352 0
Wellington

Funding & Sponsors
Funding source category [1] 297955 0
Charities/Societies/Foundations
Name [1] 297955 0
Neonatal Trust
Country [1] 297955 0
New Zealand
Funding source category [2] 297969 0
Charities/Societies/Foundations
Name [2] 297969 0
Otago Masonic Charitable Trust
Country [2] 297969 0
New Zealand
Primary sponsor type
Hospital
Name
Wellington Regional Hospital
Address
Clinical Trials Unit
Wellington Regional Hospital
Capital and Coast District Health Board
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 297017 0
University
Name [1] 297017 0
University of Otago
Address [1] 297017 0
University of Otago Wellington
23A Mein street
Newtown
Wellington 6021
Country [1] 297017 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298997 0
Health and Disability Ethics Committee
Ethics committee address [1] 298997 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298997 0
New Zealand
Date submitted for ethics approval [1] 298997 0
29/09/2017
Approval date [1] 298997 0
07/11/2017
Ethics approval number [1] 298997 0
17CEN202

Summary
Brief summary
Premature babies are prone to developing anaemia because of their immature bone marrow ('anaemia of prematurity'). Anaemia can affect their growth, breathing, and function of important organs such as the brain. Therefore, it is routinely treatment with transfusion of packed red blood cells.

Currently, all red blood cells given to premature babies are irradiated before transfusion. This is a safety measure and irradiation prevents a rare but potentially serious complications of blood transfusion (called 'transfusion-associated graft-versus-host-disease'). For logistical reasons, once red blood cells are irradiated they are stored in the Blood Bank for a period of time before they are used. However, findings from our recent study suggests that this practice of storing red blood cells after irradiation may affect the quality and/or function of red blood cells. It is possible that red blood cells which are stored after irradiation are not as good at carrying oxygen to vital organs such as the brain, when compared with freshly irradiated red blood cells.

The aim of this study is to find out if freshly irradiated red blood cells (i.e. on the day of transfusion) are more effective in carrying oxygen to the brain of anaemic babies than red blood cells irradiated and the stored before use.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2190 2190 0 0
/AnzctrAttachments/373971-NIMO-Rad Protocol_final.pdf (Protocol)
Attachments [2] 2191 2191 0 0
/AnzctrAttachments/373971-NIMO-Rad PIS (FINAL).pdf (Participant information/consent)
Attachments [3] 2192 2192 0 0
/AnzctrAttachments/373971-Consent Form NIMO-Rad (FINAL).pdf (Participant information/consent)
Attachments [4] 2193 2193 0 0
/AnzctrAttachments/373971-HDEC Letter 17CEN202_Approved FULL Application with non std conditions.pdf (Ethics approval)

Contacts
Principal investigator
Name 78942 0
Dr Max Berry
Address 78942 0
Department of Paediatrics and Child Health
University of Otago Wellington
23A Mein Street
Wellington 6021
Country 78942 0
New Zealand
Phone 78942 0
+64 21 244 9929
Fax 78942 0
Email 78942 0
[email protected]
Contact person for public queries
Name 78943 0
Dr Maria Saito-Benz
Address 78943 0
Department of Paediatrics and Child Health
University of Otago Wellington
23A Mein Street
Wellington 6021
Country 78943 0
New Zealand
Phone 78943 0
+64 21 570 609
Fax 78943 0
Email 78943 0
[email protected]
Contact person for scientific queries
Name 78944 0
Dr Maria Saito-Benz
Address 78944 0
Department of Paediatrics and Child Health
University of Otago Wellington
23A Mein Street
Wellington 6021
Country 78944 0
New Zealand
Phone 78944 0
+64 21 570 609
Fax 78944 0
Email 78944 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
IPD will potentially make participating infants identifiable


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6090Study protocol    373971-(Uploaded-05-12-2019-13-25-57)-Study-related document.pdf
6091Informed consent form    373971-(Uploaded-05-12-2019-13-26-44)-Study-related document.docx
6092Ethical approval    373971-(Uploaded-05-12-2019-13-27-27)-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
SourceTitleYear of PublicationDOI
EmbaseEffects of Freshly Irradiated vs Irradiated and Stored Red Blood Cell Transfusion on Cerebral Oxygenation in Preterm Infants: A Randomized Clinical Trial.2022https://dx.doi.org/10.1001/jamapediatrics.2022.0152
N.B. These documents automatically identified may not have been verified by the study sponsor.