Preservation of Blood in Extremely Preterm Infants (LIM)

March 24, 2023 updated by: Lund University

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"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Recruiting
        • Neonatal intensive care unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • gestational age < 27 weeks at birth

Exclusion Criteria:

  • major malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
No Intervention: Standard clinical methods for blood sample analysis
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Broncho-pulmonary dysplasia
Time Frame: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
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
Time Frame: Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
Stage II, III and IV (Periventricular hemorrhagic infarction)
Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
Necrotizing enterocolitis
Time Frame: From birth until 40 weeks postmenstrual age
Stage 2-3, Bells criteria (X-ray + clinical signs)
From birth until 40 weeks postmenstrual age
Blood transfusions
Time Frame: Blood transfusions administered during the first two postnatal weeks
Administered blood transfusions (ml/kg)
Blood transfusions administered during the first two postnatal weeks
Fetal Hemoglobin
Time Frame: % of fetal hemoglobin at 7 and 14 postnatal days
% of fetal hemoglobin
% of fetal hemoglobin at 7 and 14 postnatal days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

The Swedish Research Council

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2020

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

January 19, 2020

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00770

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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