Current clinical protocols for blood sampling and analyses in extremely preterm infants rely on an infrastructure adapted to and developed for adult medicine. Excessive blood sampling volumes and the resulting loss of fetal blood components are related to neonatal morbidity. This randomised trial aims to provide evidence that preservation of blood using micro-methods results in decreased morbidity and increased quality of life in extremely preterm infants.
Extremely preterm (EPT) infants are subjected to a sample-related withdrawal of whole blood of 50 % of total blood volume during the first 2 postnatal weeks and a transfused volume of 100 % of total blood volume with donor blood during the corresponding time period. The resulting decrease in the proportion of fetal hemoglobin is strongly associated with morbidity outcome, especially broncho-pulmonary dysplasia (BPD), in the EPT infant. This randomized trial evaluates if a reduction in sample-related blood volume loss by 50% during the first two postnatal weeks leads to a reduced rate of BPD in EPT infants. Half of the included infants will be subjected to clinical blood sampling using micromethods during the first two postnatal weeks whereas blood sampling in the other half of infants will be performed using standard clinical methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
201
Micromethods in the intervention arm are applied aiming to achieve a mean reduction of 50 % of sampled blood volume during the first two postnatal weeks as compared to standard clinical blood sampling analyses
Neonatal Intensive Care Unit
Lund, Sweden
Broncho-pulmonary dysplasia
Requirement of supplemental oxygen as determined by the oxygen challenge test
Time frame: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
Cerebral intraventricular haemorrhage
Stage II, III and IV (Periventricular hemorrhagic infarction)
Time frame: Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
Necrotizing enterocolitis
Stage 2-3, Bells criteria (X-ray + clinical signs)
Time frame: From birth until 40 weeks postmenstrual age
Blood transfusions
Administered blood transfusions (ml/kg)
Time frame: Blood transfusions administered during the first two postnatal weeks
Fetal Hemoglobin
% of fetal hemoglobin
Time frame: % of fetal hemoglobin at 7 and 14 postnatal days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.