Clinical trial NCT04239690: Preservation of Blood in Extremely Preterm Infants
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
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Keywords: Extremely preterm infant
Blood sampling
Blood transfusion
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2020-01-27
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* gestational age \< 27 weeks at birth

Exclusion Criteria:

* major malformation

Primary outcomes:
measure: Broncho-pulmonary dysplasia
timeFrame: Broncho-pulmonary dysplasia is determined at a postmenstrual age of 36 weeks
Secondary outcomes:
measure: Cerebral intraventricular haemorrhage
timeFrame: Ultrasound at postnatal day 3, 7, 21 and 40 weeks postmenstrual age
measure: Necrotizing enterocolitis
timeFrame: From birth until 40 weeks postmenstrual age
measure: Blood transfusions
timeFrame: Blood transfusions administered during the first two postnatal weeks
measure: Fetal Hemoglobin
timeFrame: % of fetal hemoglobin at 7 and 14 postnatal days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Neonatal Intensive Care Unit
Study officials:
affiliation: Lund University, Lund, Sweden
name: David Ley, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.