Preservation of Blood in Extremely Preterm Infants

Not Applicable

Recruiting

• Conditions: Bronchopulmonary Dysplasia
• Interventions: Other: Micromethods for blood sample analysis

• Registration Number: NCT04239690
• Lead Sponsor: Lund University

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.

Study Timeline

• Study First Submitted: 2020-01-19
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-03-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-10-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• gestational age < 27 weeks at birth

Exclusion Criteria

• major malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micromethods for blood sample analysis	Micromethods for blood sample analysis	Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Blood transfusions	Blood transfusions administered during the first two postnatal weeks	Administered blood transfusions (ml/kg)
Necrotizing enterocolitis	From birth until 40 weeks postmenstrual age	Stage 2-3, Bells criteria (X-ray + clinical signs)
Fetal Hemoglobin	% of fetal hemoglobin at 7 and 14 postnatal days	% of fetal hemoglobin
Cerebral intraventricular haemorrhage	Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age	Stage II, III and IV (Periventricular hemorrhagic infarction)

Trial Locations

Locations (1)

Neonatal Intensive Care Unit; 🇸🇪 Lund, Sweden