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Preservation of Blood in Extremely Preterm Infants (LIM)

Primary Purpose

Bronchopulmonary Dysplasia

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Micromethods for blood sample analysis

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Extremely preterm infant, Blood sampling, Blood transfusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

gestational age < 27 weeks at birth

Exclusion Criteria:

major malformation

Sites / Locations

Neonatal Intensive Care UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Micromethods for blood sample analysis

Standard clinical methods for blood sample analysis

Arm Description

Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood

Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood

Outcomes

Primary Outcome Measures

Broncho-pulmonary dysplasia

Requirement of supplemental oxygen as determined by the oxygen challenge test

Secondary Outcome Measures

Cerebral intraventricular haemorrhage

Stage II, III and IV (Periventricular hemorrhagic infarction)

Necrotizing enterocolitis

Stage 2-3, Bells criteria (X-ray + clinical signs)

Blood transfusions

Administered blood transfusions (ml/kg)

Fetal Hemoglobin

% of fetal hemoglobin

Full Information

NCT ID

NCT04239690

First Posted

January 19, 2020

Last Updated

March 24, 2023

Sponsor

Lund University

Collaborators

The Swedish Research Council

1. Study Identification

Unique Protocol Identification Number

NCT04239690

Brief Title

Preservation of Blood in Extremely Preterm Infants

Acronym

LIM

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"

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2020 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lund University

Collaborators

The Swedish Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia

Keywords

Extremely preterm infant, Blood sampling, Blood transfusion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

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.

Allocation

Randomized

Enrollment

210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Micromethods for blood sample analysis

Arm Type

Experimental

Arm Description

Blood gases are analysed using 0.045 ml whole blood Levels of C-reactive protein (CRP) are analysed using 0.010 ml whole blood

Arm Title

Standard clinical methods for blood sample analysis

Arm Type

No Intervention

Arm Description

Blood gases are analysed using 0.3 ml whole blood Levels of CRP are analysed using 0.5 ml whole blood

Intervention Type

Other

Intervention Name(s)

Micromethods for blood sample analysis

Intervention Description

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 Outcome Measure Information:

Title

Broncho-pulmonary dysplasia

Description

Requirement of supplemental oxygen as determined by the oxygen challenge test

Time Frame

Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks

Secondary Outcome Measure Information:

Title

Cerebral intraventricular haemorrhage

Description

Stage II, III and IV (Periventricular hemorrhagic infarction)

Time Frame

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

Title

Necrotizing enterocolitis

Description

Stage 2-3, Bells criteria (X-ray + clinical signs)

Time Frame

From birth until 40 weeks postmenstrual age

Title

Blood transfusions

Description

Administered blood transfusions (ml/kg)

Time Frame

Blood transfusions administered during the first two postnatal weeks

Title

Fetal Hemoglobin

Description

% of fetal hemoglobin

Time Frame

% of fetal hemoglobin at 7 and 14 postnatal days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: gestational age < 27 weeks at birth Exclusion Criteria: major malformation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Ley, MD, PhD

Phone

+46709264524

david.ley@med.lu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Eva Morsing, MD, PhD

Phone

+46708788442

eva.morsing@med.lu.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Ley, MD, PhD

Organizational Affiliation

Lund University, Lund, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal Intensive Care Unit

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Ley, MD, PhD

Phone

004646178440

david.ley@med.lu.se

First Name & Middle Initial & Last Name & Degree

Eva Morsing, MD, PhD

Phone

0046178449

eva.morsing@med.lu.se

12. IPD Sharing Statement

Citations:

PubMed Identifier

33547036

Citation

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.

Results Reference

derived

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Preservation of Blood in Extremely Preterm Infants

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