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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)

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001581358
Acronym
NIMO-Rad
Enrollment
64
Registered
2017-11-27
Start date
2017-12-04
Completion date
2018-11-01
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 o

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.

Sponsors

Wellington Regional Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
14 Days to 3 Months
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026