Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000502437
Ethics application status
Approved
Date submitted
8/04/2016
Date registered
19/04/2016
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Near-Infrared spectroscopy for Monitoring Oxygenation during blood transfusion in Anaemic Infants
Scientific title
Effect of elective blood transfusion on cerebral, hepatic and muscle regional oxygenation and cardiovascular stability in anaemic neonates
Secondary ID [1] 288958 0
Nil known
Universal Trial Number (UTN)
U1111-1181-7254
Trial acronym
NIMO-AI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 298331 0
Condition category
Condition code
Blood 298448 298448 0 0
Anaemia
Reproductive Health and Childbirth 298476 298476 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
This is an observational study, and as such the decision to give a blood transfusion to neonates will be made solely by the clinical staff attending the infants. In Wellington NICU, there is a blood transfusion guideline to assist clinicians in deciding the timing of transfusion.

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 this study:

1) Patient characteristics
* Gestational age
* Postnatal age
* Ethnicity
* Sex
* Birth weight
* Weight at time of transfusion
* Haemoglobin and Haematocrit count prior to transfusion
* Respiratory support required at time of transfusion, 24hrs and 5 days after transfusion
* Caffeine treatment

2) Cerebral and somatic near infra-red spectroscopy (NIRS)
Cerebral and somatic regional oxygenation levels will be measured for 3hrs pre-, during and immediately post transfusion, and at 24hrs and 5 days post transfusion. Multi-site NIRS system (Nonin SenSmartTM Model X-100) with non- adhesive regional oximetry sensors will be used (EQUANOX Advanced 9004CB- NA Paediatric/Neonatal). The Paediatric/Neonatal sensors have the advantage of having a completely flat surface to avoid pressure-related injury on fragile skin of infants. They will be attached to infants using soft elastic bandages or a Tegaderm, which are routinely used in clinical practice.

The sensors will be positioned using a standard template to minimise inter- observer variability in sensor placement. The following organ systems will be studied:

Brain: Left fronto-parietal area of infant’s head. Two lateral LED emitters should avoid the midline (to avoid interference by the sagittal sinus) and hair.
Liver: Point-of-care ultrasound will be performed to ensure that probe is placed adjacent to the organ
Muscle: Sensor will be placed vertically on left gastrocnemius muscle (right gastrocnemius, or quadriceps muscles may be used instead if there is a clinical reason to avoid certain locations, e.g. long-line placement, peripheral IV, recent tissue extravasation)

3) Cardiorespiratory stability
a. Heart rate and peripheral arterial saturation will be recorded using a pulse oximeter (MassimoRadical8TM) for 12 hours prior to transfusion, during transfusion and again for 12 hours at 24hrs and 5 days post transfusion.

b. Non-invasive, continuous blood pressure monitoring will be performed using a set of soft blood pressure cuffs (Human NIBP SetTM) for 12 hours prior to transfusion, during transfusion and again for 12 hours at 24hrs and 5 days post transfusion.

Note: Infants will be placed supine during data collection unless medically indicated for them to lie in other positions (sleep position of infants will be recorded as part of study). This is because sleep position is known to affect parameters of cardiorespiratory stability.
Intervention code [1] 294443 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297945 0
Cerebral oxygenation, assessed by near infrared spectroscopy
Timepoint [1] 297945 0
Cerebral oxygenation will be monitored for 3 hours at each of the following timepoints:
1. Immediately prior to blood transfusion
2. During blood transfusion (it is a routine practice to give blood transfusion over 3 hours)
3. Immediately after blood transfusion is completed
4. 1 day post transfusion
5. 5 days post transfusion
Secondary outcome [1] 322692 0
Hepatic oxygenation, assessed by near infrared spectroscopy
Timepoint [1] 322692 0
Hepatic oxygenation will be monitored for 3 hours at each of the following timepoints:
1. Immediately prior to blood transfusion
2. During blood transfusion (it is a routine practice to give blood transfusion over 3 hours)
3. Immediately after blood transfusion is completed
4. 1 day post transfusion
5. 5 days post transfusion
Secondary outcome [2] 322693 0
Muscle oxygenation, assessed by near infrared spectroscopy
Timepoint [2] 322693 0
Muscle oxygenation will be monitored for 3 hours at each of the following timepoints:
1. Immediately prior to blood transfusion
2. During blood transfusion (it is a routine practice to give blood transfusion over 3 hours)
3. Immediately after blood transfusion is completed
4. 1 day post transfusion
5. 5 days post transfusion
Secondary outcome [3] 322778 0
Proportion of neonates with an improvement in cardiorespiratory stability defined as a reduction in the frequency and duration of desaturation (peripheral arterial saturation), bradycardia and low blood pressure. The cardiorespiratory stability will be monitored using a pulse oximeter (Massimo Rad 8) and a non-invasive continuous blood pressure monitor (Human NIBP set).
Timepoint [3] 322778 0
The cardiorespiratory stability will be monitor for 12 hours at each of the following timepoints:
1. Immediately prior to blood transfusion
2. 1 day post transfusion
3. 5 days post transfusion

Eligibility
Key inclusion criteria
Neonates in Wellington NICU will be considered for recruitment into the study if they are diagnosed with anaemia and the attending clinical team makes a decision to give non-urgent blood transfusion.

Note: A 'neonate' is defined as 6 weeks corrected postnatal age or younger.
Minimum age
No limit
Maximum age
6 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with following criteria will be excluded from the study if:

1. Urgent blood transfusion is required
2. Mechanically ventilated at the time of transfusion
3. Undergoing treatment for systemic infection with broad spectrum antibiotics
4. Receiving medical treatment or are awaiting surgery for a haemodynamically significant patent ductus arteriosus (PDA)
5. Significantly oedematous

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power analysis:
We calculated that a sample size of at least 24 infants is required to detect a significant increase of 10% in cerebral regional oxygenation 24hrs post transfusion with 80% power using p-value of 0.05 and the margin of error of +/- 4%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2016
Actual
11/05/2016
Date of last participant enrolment
Anticipated
29/07/2016
Actual
22/11/2016
Date of last data collection
Anticipated
Actual
27/11/2016
Sample size
Target
24
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 7798 0
New Zealand
State/province [1] 7798 0
Wellington

Funding & Sponsors
Funding source category [1] 293314 0
University
Name [1] 293314 0
University of Otago, Wellington
Country [1] 293314 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] 292128 0
Government body
Name [1] 292128 0
Capital and Coast District Health Board
Address [1] 292128 0
Clinical Trials Unit
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 292128 0
New Zealand
Other collaborator category [1] 278940 0
Individual
Name [1] 278940 0
Dr. Max Berry
Address [1] 278940 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein street
Newtown 6021
Wellington
Country [1] 278940 0
New Zealand
Other collaborator category [2] 278941 0
Individual
Name [2] 278941 0
Prof. Dawn Elder
Address [2] 278941 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein street
Newtown 6021
Wellington
Country [2] 278941 0
New Zealand
Other collaborator category [3] 278942 0
Individual
Name [3] 278942 0
Prof. Shieak Tzeng
Address [3] 278942 0
Centre of Translational Physiology
University of Otago, Wellington
23A Mein street
Newtown 6021
Wellington
Country [3] 278942 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294789 0
Health and Disability Ethics Committees
Ethics committee address [1] 294789 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 294789 0
New Zealand
Date submitted for ethics approval [1] 294789 0
10/02/2016
Approval date [1] 294789 0
01/04/2016
Ethics approval number [1] 294789 0
16/CEN/18

Summary
Brief summary
Newborn babies in neonatal intensive care units are prone to developing anaemia because of their immature bone marrow and frequent blood sampling required for ongoing monitoring. Anaemia in these infants, if left untreated, can result in lethargy, suboptimal growth and nutrition, ongoing requirement for respiratory support, and cardiovascular instability. Currently elective (i.e. non­-urgent) blood transfusion is the treatment of choice for anaemia in these infants; however, there is no consensus in the literature on the ideal treatment threshold.

This study aims to develop better understanding of the mechanism by which elective blood transfusion benefits neonates with anaemia. More specifically it will examine whether elective blood transfusion increases availability of oxygen to the brain, liver and muscle. It also aims to examine whether such changes are sustained beyond the initial 24hrs of transfusion, and correlate such findings to markers of cardiorespiratory stability (frequency of peripheral desaturation, blood pressure stability and heart rate).

This is an observational study, and the decision to give elective blood transfusion will be made only by the attending clinicians. Once the decision to give transfusion is made, parents of potential participants will be approached for enrollment in the study.

The study involves use of non-­invasive devices to measure physiological parameters. Cerebral, hepatic and muscle regional oxygenation will be measured using Near­-infrared Spectroscopy (NIRS). Parameters of cardiorespiratory stability will be measured using a pulse oximeter and a Human NIBP set (non-­invasive continuous blood pressure cuffs). Measurements will be taken before, during and immediately after a blood transfusion, as well as at 24hrs and 5 days post­-transfusion.
Trial website
Trial related presentations / publications
Saito-Benz M, Tzeng YC, Gately C, Berry MJ. 'Effect of elective blood transfusion on cerebral and somatic tissue oxygenation and cardio-respiratory stability in infants with Anaemia of Prematurity (AoP). Presented at the Perinatal Society of Australia and New Zealand Annual meeting in Canberra, April 2017.
Public notes
Attachments [1] 828 828 0 0
/AnzctrAttachments/370496-NIMO-AI study Protocol.pdf
Attachments [2] 829 829 0 0
/AnzctrAttachments/370496-Participant Information Sheet NIMO-AI.pdf
Attachments [3] 830 830 0 0
/AnzctrAttachments/370496-Consent Form NIMO-AI .docx
Attachments [4] 831 831 0 0
/AnzctrAttachments/370496-HDEC Letter of Approval NIMO-AI (16CEN18) .pdf
Attachments [5] 832 832 0 0
/AnzctrAttachments/370496-HDEC application NIMO-AI.pdf
Attachments [6] 833 833 0 0
/AnzctrAttachments/370496-NIMO-AI locality approval.pdf

Contacts
Principal investigator
Name 65042 0
Dr Maria Saito-Benz
Address 65042 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 65042 0
New Zealand
Phone 65042 0
+64 21 570 609
Fax 65042 0
Email 65042 0
[email protected]
Contact person for public queries
Name 65043 0
Mrs Melody Beecroft
Address 65043 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 65043 0
New Zealand
Phone 65043 0
+64 4 918 6138
Fax 65043 0
+64 4 385 5898
Email 65043 0
[email protected]
Contact person for scientific queries
Name 65044 0
Dr Maria Saito-Benz
Address 65044 0
Department of Paediatrics and Child Health
University of Otago, Wellington
23A Mein Street
Newtown
Wellington 6021
Country 65044 0
New Zealand
Phone 65044 0
+64 21 570 609
Fax 65044 0
Email 65044 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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