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NCT Number: NCT04239690

Preservation of Blood in Extremely Preterm Infants

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Respiratory Tract Diseases Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit

Lund, 221 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gestational age < 27 weeks at birth

Exclusion criteria

  • major malformation

Treatment and study plan

Micromethods for blood sample analysis

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

David Ley

Other

Registry information

Official study 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"

Acronym: LIM

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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