NCT04239690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

4.3 years

First QC Date

January 19, 2020

Last Update Submit

November 25, 2025

Conditions

Bronchopulmonary Dysplasia

Keywords

Extremely preterm infantBlood samplingBlood transfusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cerebral intraventricular haemorrhage

    Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age

  • Necrotizing enterocolitis

    From birth until 40 weeks postmenstrual age

  • Blood transfusions

    Blood transfusions administered during the first two postnatal weeks

  • Fetal Hemoglobin

    % of fetal hemoglobin at 7 and 14 postnatal days

Study Arms (2)

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

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

Interventions

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

Micromethods for blood sample analysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • gestational age \< 27 weeks at birth

You may not qualify if:

  • major malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Intensive Care Unit

Lund, 221 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 37169579DERIVED

  • Hellstrom 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.

    PMID: 33547036DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David Ley, MD, PhD

    Lund University, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 27, 2020

Study Start

March 15, 2020

Primary Completion

June 15, 2024

Study Completion

July 15, 2024

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

SE(1)