Bronchopulmonary Dysplasia
Conditions
Keywords
Extremely preterm infant, Blood sampling, Blood transfusion
Brief summary
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.
Detailed description
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.
Interventions
OTHERMicromethods for blood sample analysis
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
Sponsors
David Ley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Prevalence and severity of BPD at 36 weeks post-menstrual age is determined by the oxygen challenge test performed by a trained respiratory nurse blinded to treatment at each study site.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* gestational age \< 27 weeks at birth
Exclusion criteria
* major malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Broncho-pulmonary dysplasia | Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks | Requirement of supplemental oxygen as determined by the oxygen challenge test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral intraventricular haemorrhage | Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age | Stage II, III and IV (Periventricular hemorrhagic infarction) |
| Necrotizing enterocolitis | From birth until 40 weeks postmenstrual age | Stage 2-3, Bells criteria (X-ray + clinical signs) |
| Blood transfusions | Blood transfusions administered during the first two postnatal weeks | Administered blood transfusions (ml/kg) |
| Fetal Hemoglobin | % of fetal hemoglobin at 7 and 14 postnatal days | % of fetal hemoglobin |
Countries
Sweden
Outcome results
None listed