Preservation of Blood in Extremely Preterm Infants

Bronchopulmonary Dysplasia Clinical Trial

— LIM  

Official title:

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239690
• Other study ID #: 2018-00770
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2023
• Source: Lund University
• Contact: David Ley, MD, PhD
• Phone: +46709264524
• Email: david.ley[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• gestational age < 27 weeks at birth

Exclusion Criteria:

• major malformation

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Other:
• Micromethods for blood sample analysis
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

Locations

Country	Name	City	State
Sweden	Neonatal Intensive Care Unit	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

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