None listed
Conditions
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.
Interventions
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
* Gestationa
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.
Sponsors
Dr. Maria Saito-Benz
Eligibility
Sex/Gender
All
Age
No minimum to 6 Weeks
Healthy volunteers
No
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.
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
Outcome results
None listed