Preservation of Blood in Extremely Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bronchopulmonary Dysplasia

Intervention / Treatment
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* Other: Micromethods for blood sample analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gestational age < 27 weeks at birth Exclusion Criteria: major malformation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micromethods for blood sample analysis<br>Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood | Other: Micromethods for blood sample analysis<br>* 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<br>|
| No Intervention: Standard clinical methods for blood sample analysis<br>Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extremely preterm infant, Blood sampling, Blood transfusion