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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micromethods for blood sample analysis | Experimental | Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood |
|
| Standard clinical methods for blood sample analysis | No Intervention | Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micromethods for blood sample analysis | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Broncho-pulmonary dysplasia | Requirement of supplemental oxygen as determined by the oxygen challenge test | Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral intraventricular haemorrhage | Stage II, III and IV (Periventricular hemorrhagic infarction) | Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age |
| Necrotizing enterocolitis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ley, MD, PhD | Lund University, Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit | Lund | 221 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37169579 | Derived | Larsson SM, Ulinder T, Rakow A, Vanpee M, Wackernagel D, Savman K, Hansen-Pupp I, Hellstrom A, Ley D, Andersson O. Hyper high haemoglobin content in red blood cells and erythropoietic transitions postnatally in infants of 22 to 26 weeks' gestation: a prospective cohort study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):612-616. doi: 10.1136/archdischild-2022-325248. Epub 2023 May 11. | |
| 33547036 |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Parallel assignment
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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.
Stage 2-3, Bells criteria (X-ray + clinical signs)
| From birth until 40 weeks postmenstrual age |
| Blood transfusions | Administered blood transfusions (ml/kg) | Blood transfusions administered during the first two postnatal weeks |
| Fetal Hemoglobin | % of fetal hemoglobin | % of fetal hemoglobin at 7 and 14 postnatal days |
| Derived |
| Hellstrom W, Martinsson T, Morsing E, Granse L, Ley D, Hellstrom A. Low fraction of fetal haemoglobin is associated with retinopathy of prematurity in the very preterm infant. Br J Ophthalmol. 2022 Jul;106(7):970-974. doi: 10.1136/bjophthalmol-2020-318293. Epub 2021 Feb 5. |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |