LIM: Preservation of Blood in Extremely Preterm Infants

Sponsor

Lund University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04239690

Collaborator

The Swedish Research Council (Other)

210

Enrollment

Location

Arms

39.5

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia	Other: Micromethods for blood sample analysis	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallell assignmentParallell 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 :

Mar 15, 2020

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Broncho-pulmonary dysplasia [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

Cerebral intraventricular haemorrhage [Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age]
Stage II, III and IV (Periventricular hemorrhagic infarction)
Necrotizing enterocolitis [From birth until 40 weeks postmenstrual age]
Stage 2-3, Bells criteria (X-ray + clinical signs)
Blood transfusions [Blood transfusions administered during the first two postnatal weeks]
Administered blood transfusions (ml/kg)
Fetal Hemoglobin [% of fetal hemoglobin at 7 and 14 postnatal days]
% of fetal hemoglobin

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

gestational age < 27 weeks at birth

Exclusion Criteria:

major malformation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neonatal Intensive Care Unit	Lund		Sweden	221 85

Sponsors and Collaborators

Lund University
The Swedish Research Council

Investigators

Principal Investigator: David Ley, MD, PhD, Lund University, Lund, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lund University

ClinicalTrials.gov Identifier:

NCT04239690

Other Study ID Numbers:

2018-00770

First Posted:

Jan 27, 2020

Last Update Posted:

May 13, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lund University

Extremely preterm infant

Blood sampling

Blood transfusion

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia

Study Results

No Results Posted as of May 13, 2021