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Preservation of Blood in Extremely Preterm Infants (LIM)

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ClinicalTrials.gov Identifier: NCT04239690
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Lund University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Other: Micromethods for blood sample analysis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallell assignment
Masking: Single (Outcomes Assessor)
Masking Description: Prevalence and severity of BPD at 36 weeks post-menstrual age is determined by the oxygen challenge test performed by a trained respiratory nurse blinded to treatment at each study site.
Primary Purpose: Prevention
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"
Actual Study Start Date : March 15, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Micromethods for blood sample analysis
Blood gases are analysed using 0.045 ml whole blood Levels of 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Necrotizing enterocolitis [ Time Frame: From birth until 40 weeks postmenstrual age ]
    Stage 2-3, Bells criteria (X-ray + clinical signs)

  3. Blood transfusions [ Time Frame: Blood transfusions administered during the first two postnatal weeks ]
    Administered blood transfusions (ml/kg)

  4. Fetal Hemoglobin [ Time Frame: % of fetal hemoglobin at 7 and 14 postnatal days ]
    % of fetal hemoglobin


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age < 27 weeks at birth

Exclusion Criteria:

  • major malformation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239690


Contacts
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Contact: David Ley, MD, PhD +46709264524 david.ley@med.lu.se
Contact: Eva Morsing, MD, PhD +46708788442 eva.morsing@med.lu.se

Locations
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Sweden
Neonatal Intensive Care Unit Recruiting
Lund, Sweden, 221 85
Contact: David Ley, MD, PhD    004646178440    david.ley@med.lu.se   
Contact: Eva Morsing, MD, PhD    0046178449    eva.morsing@med.lu.se   
Sponsors and Collaborators
Lund University
The Swedish Research Council
Investigators
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Principal Investigator: David Ley, MD, PhD Lund University, Lund, Sweden
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT04239690    
Other Study ID Numbers: 2018-00770
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
Extremely preterm infant
Blood sampling
Blood transfusion
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases