Bronchopulmonary DysplasiaLIMNCT04239690
Preservation of Blood in Extremely Preterm Infants
A study testing Micromethods for blood sample analysis in people with Bronchopulmonary Dysplasia, run by David Ley at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Micromethods for blood sample analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2020to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- gestational age < 27 weeks at birth
Who cannot join
- major malformation
Trial locations and contacts
1 site in 1 country.
About this study
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"
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Micromethods for blood sample analysis
- Keywords
- Extremely preterm infant, Blood sampling, Blood transfusion
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micromethods for blood sample analysisOther
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
| Study group | Role | What they receive |
|---|---|---|
| Micromethods for blood sample analysis | Experimental | Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood Receives: Other: Micromethods for blood sample analysis |
| Standard clinical methods for blood sample analysis | No intervention | Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Broncho-pulmonary dysplasia
Requirement of supplemental oxygen as determined by the oxygen challenge test
Measured: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
Secondary outcomes (4)
Cerebral intraventricular haemorrhage
Stage II, III and IV (Periventricular hemorrhagic infarction)
Measured: Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
Necrotizing enterocolitis
Stage 2-3, Bells criteria (X-ray + clinical signs)
Measured: From birth until 40 weeks postmenstrual age
Blood transfusions
Administered blood transfusions (ml/kg)
Measured: Blood transfusions administered during the first two postnatal weeks
Fetal Hemoglobin
% of fetal hemoglobin
Measured: % of fetal hemoglobin at 7 and 14 postnatal days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Mar 2020
- Primary completion15 Jun 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Ley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Ley, Lund University
- Investigators
- David Ley, MD, PhD, Principal investigator, Lund University, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239690
- Sponsor's protocol ID
- 2018-00770
- Other IDs
- 2018
- Acronym
- LIM
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2020
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larsson SM, Ulinder T, Rakow A, Vanpee M, Wackernagel D, Savman K, Hansen-Pupp I, Hellstrom A, Ley D, Andersson O. Hyper high haemoglobin content in red blood cells and erythropoietic transitions postnatally in infants of 22 to 26 weeks' gestation: a prospective cohort study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):612-616. doi: 10.1136/archdischild-2022-325248. Epub 2023 May 11.
PubMed 37169579Hellstrom W, Martinsson T, Morsing E, Granse L, Ley D, Hellstrom A. Low fraction of fetal haemoglobin is associated with retinopathy of prematurity in the very preterm infant. Br J Ophthalmol. 2022 Jul;106(7):970-974. doi: 10.1136/bjophthalmol-2020-318293. Epub 2021 Feb 5.
PubMed 33547036
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04239690
- Acronym / sponsor ID
- LIM / 2018-00770
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Extremely preterm infant, Blood sampling, Blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- David LeyUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Micromethods for blood sample analysis | Experimental | Other: Micromethods for blood sample analysisBlood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood |
| Standard clinical methods for blood sample analysis | No intervention | –Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- gestational age < 27 weeks at birth
Key exclusion criteria (1 listed)
- major malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micromethods for blood sample analysisMicromethods 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 | Other | Micromethods for blood sample analysis |
Primary outcome
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
4 secondary outcomes
Cerebral intraventricular haemorrhage
Time frame: Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
Necrotizing enterocolitis
Time frame: From birth until 40 weeks postmenstrual age
Blood transfusions
Time frame: Blood transfusions administered during the first two postnatal weeks
Fetal Hemoglobin
Time frame: % of fetal hemoglobin at 7 and 14 postnatal days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 37169579Larsson SM, Ulinder T, Rakow A, Vanpee M, Wackernagel D, Savman K, Hansen-Pupp I, Hellstrom A, Ley D, Andersson O. Hyper high haemoglobin content in red blood cells and erythropoietic transitions postnatally in infants of 22 to 26 weeks' gestation: a prospective cohort study. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):612-616. doi: 10.1136/archdischild-2022-325248. Epub 2023 May 11.
- Derived from this study: PubMed 33547036Hellstrom W, Martinsson T, Morsing E, Granse L, Ley D, Hellstrom A. Low fraction of fetal haemoglobin is associated with retinopathy of prematurity in the very preterm infant. Br J Ophthalmol. 2022 Jul;106(7):970-974. doi: 10.1136/bjophthalmol-2020-318293. Epub 2021 Feb 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ley, MD, PhD principal investigator
Lund University, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micromethods for blood sample analysis in people with Bronchopulmonary Dysplasia, run by David Ley at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Broncho-pulmonary dysplasia (time frame: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04239690, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.