The use of blood transfusion in European preterm infants Neonatal Diseases
Conditions
Interventions
In this international, multicenter, prospective, observational point prevalence study, the researchers will include neonates with gestational age at birth <32 weeks admitted to a participating tertiar
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A potential subject who meets both of the following criteria can be included in this study: 1. Admission to a participating tertiary level NICU during the study period (note: this also includes neonates who are admitted to the NICU prior to the start of the study period, born outside the NICU institute of admission and/or readmitted to the NICU) 2. Gestational age at birth below 32 weeks (note: the postmenstrual age [PMA; gestational age + chronological age] at admission can be =32+0 weeks, however the PMA at inclusion cannot exceed 44+0 weeks)
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The prevalence and incidence of RBC, platelet, and plasma transfusions in neonates with a gestational age of less than 32 weeks at birth, admitted to a tertiary-level NICU: 1.1. The prevalence is calculated by dividing the number of transfusions of the respective transfusion type by the total sum of neonate study days 1.2. The incidence of receiving at least one transfusion, both for any transfusion as per transfusion type, is calculated by dividing the number of neonates receiving at least one transfusion by the total sum of neonate study days Each participating center will collect data during a 6-week period, in which they will screen all 7 days of these weeks for the study outcomes in the included neonates. For neonates already admitted at the start of the study, the start of patient follow-up in the study is equal to the first day of the study period in the participating center. For all other included infants, the start of patient follow-up equals the day of admission. The end of patient follow-up in the study is equal to the day of death, the day of transfer, the day of discharge, or the last day of the study period in the center (whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Variations in prevalence rates of RBC, platelet, and plasma transfusions. Data analysis will be predominantly descriptive, comparing both participating countries and different types of NICUs. Types of NICUs will be defined based on unit size and whether surgical procedures are being performed. 2. Indications for transfusion: the primary indication for which the transfusion is prescribed by the treating physician will be collected. If applicable, the secondary and tertiary indications will also be registered, as clinicians may consider multiple factors when deciding to give a transfusion. For each transfusion, the prescribing physician must choose from a list of predefined indications (up to three options can be selected, ranked primary to tertiary indication). The primary indication is the indication that has the most weight in the decision to prescribe a transfusion. If the indication for transfusion is registered by someone other than the prescribing physician, the prescribing physician must confirm the correctness of these data. 3. Duration, volume, and transfusion rate of the prescribed RBC, platelet, and plasma transfusions 4. Guideline use: data is collected on whether centers have guidelines in place regarding RBC, platelet, and plasma transfusion for neonates. Following the implementation model by Wensing and Grol, information is gathered on the implementation of transfusion guidelines. Additionally, the researchers will ask centers with established guidelines to provide the guidelines in place at the start of data collection. The researchers will analyse how many of the RBC and platelet guidelines have already incorporated the results of recent clinical trials. They will categorize the existing RBC guidelines into “TOP and/or ETTNO incorporated” and “TOP and/or ETTNO not incorporated”. They will categorize the existing platelet guidelines into “PlaNeT-2/MATISSE incorporated” and “PlaNeT-2/MATISSE not incorporated”. They will assess to what extent centers | — |
Countries
Austria, Bosnia and Herzegovina, Croatia, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland
Outcome results
None listed