Preservation of Blood in Extremely Preterm Infants (LIM)

Lund University

Status: Enrolling

Conditions: Bronchopulmonary Dysplasia

Treatments: Other: Micromethods for blood sample analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04239690

2018-00770

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age < 27 weeks at birth

Exclusion criteria

• major malformation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Micromethods for blood sample analysis

Experimental group

Description:

Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood

Treatment:

Other: Micromethods for blood sample analysis

Standard clinical methods for blood sample analysis

No Intervention group

Description:

Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood