A Randomised Controlled Intervention, Multi-centre Study Aiming to Preserve Blood Factors Using Micro-methods to Improve Development in Extremely Preterm Infants - "Less is More"
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- David Ley
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Broncho-pulmonary dysplasia
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
Investigators
David Ley
Professor
Lund University
Eligibility Criteria
Inclusion Criteria
- •gestational age \< 27 weeks at birth
Exclusion Criteria
- •major malformation
Outcomes
Primary Outcomes
Broncho-pulmonary dysplasia
Time Frame: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
Requirement of supplemental oxygen as determined by the oxygen challenge test
Secondary Outcomes
- Blood transfusions(Blood transfusions administered during the first two postnatal weeks)
- Necrotizing enterocolitis(From birth until 40 weeks postmenstrual age)
- Fetal Hemoglobin(% of fetal hemoglobin at 7 and 14 postnatal days)
- Cerebral intraventricular haemorrhage(Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age)