Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants
ETTNO
2 other identifiers
interventional
1,013
2 countries
32
Brief Summary
To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2011
Longer than P75 for phase_4
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2011
CompletedFirst Posted
Study publicly available on registry
July 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2018
CompletedSeptember 16, 2021
September 1, 2021
5.8 years
July 12, 2011
September 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of death or major neurodevelopmental impairment
The primary outcome measure of this study will be the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive delay defined as mental developmental index (MDI) score of the Bayley Scales of Infant Development (2nd edition) \< 85, cerebral palsy, or severe visual or hearing impairment
24 months of age corrected for prematurity
Study Arms (2)
"liberal" transfusion triggers
EXPERIMENTAL"liberal" guidelines for red blood cell transfusions
"restrictive" transfusion triggers
ACTIVE COMPARATOR"restrictive" guidelines for red blood cell transfusions
Interventions
Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants
Eligibility Criteria
You may qualify if:
- Infants with a birth weight of 400 - 999g
You may not qualify if:
- Missing written parental consent.
- Gestational age \> 29 + 6/7 weeks
- Major congenital anomalies (including chromosomal aberrations, cyanotic congenital heart defects, syndromes likely affecting long-term outcome, and major congenital malformations requiring surgical correction during newborn period).
- Infants who died before 48 hours, infants in whom the clinical decision to withhold intensive care was made, infants who were not considered viable
- Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- German Research Foundationcollaborator
Study Sites (32)
Neonatalklinikken
Copenhagen, 2100, Denmark
University Hospital of Aachen
Aachen, 52074, Germany
Children's Hospital
Augsburg, 86156, Germany
Vivantes Children's Hospital
Berlin, 12351, Germany
Charité University Children's Hospital
Berlin, 13353, Germany
University Children's Hospital
Bochum, 44791, Germany
Children's Hospital
Cologne, 50375, Germany
University Children's Hospital
Cologne, 50924, Germany
Children's Hospital
Datteln, 45711, Germany
University Children's Hospital
Dresden, 01307, Germany
University of Duesseldorf
Düsseldorf, 40225, Germany
Helios Children's Hospital
Erfurt, 99089, Germany
Children's Hospital
Erlangen, 91054, Germany
University Children's Hospital
Essen, 45122, Germany
University Children's Hospital
Frankfurt, 60590, Germany
University Children's Hospital
Giessen, 35385, Germany
University of Greifswald
Greifswald, 17475, Germany
Children's Hospital Eppendorf
Hamburg, 20246, Germany
Children's Hospital Altona
Hamburg, 22763, Germany
Children's Hospital
Hanover, 30625, Germany
University Hospital of Leipzig
Leipzig, 04103, Germany
University of Luebeck
Lübeck, 23538, Germany
University Children's Hospital
Magdeburg, 39120, Germany
University Hospital of Marburg
Marburg, 35033, Germany
University Children's Hospital
Munich, 80337, Germany
University Children's Hospital
Münster, 48149, Germany
Children's Hospital
Nuremberg, 90471, Germany
Children's Hospital St. Hedwig
Regensburg, 93049, Germany
DRK Kinderklinik
Siegen, 57072, Germany
Children's Hospital
Stuttgart, 70176, Germany
University Hospital of Tuebingen
Tübingen, 72076, Germany
University Children's Hospital
Ulm, 89075, Germany
Related Publications (6)
ETTNO Investigators. The 'Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth-Weight Infants (ETTNO)' Study: Background, Aims, and Study Protocol. Neonatology. 2012 Jun;101(4):301-305. doi: 10.1159/000335030. Epub 2012 Jan 27.
PMID: 22298226BACKGROUNDFranz AR, Engel C, Bassler D, Rudiger M, Thome UH, Maier RF, Krageloh-Mann I, Kron M, Essers J, Buhrer C, Rellensmann G, Rossi R, Bittrich HJ, Roll C, Hohn T, Ehrhardt H, Avenarius S, Korner HT, Stein A, Buxmann H, Vochem M, Poets CF; ETTNO Investigators. Effects of Liberal vs Restrictive Transfusion Thresholds on Survival and Neurocognitive Outcomes in Extremely Low-Birth-Weight Infants: The ETTNO Randomized Clinical Trial. JAMA. 2020 Aug 11;324(6):560-570. doi: 10.1001/jama.2020.10690.
PMID: 32780138RESULTCarson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PMID: 41114449DERIVEDFranz AR, Engel C, Bassler D, Rudiger M, Thome UH, Maier RF, Krageloh-Mann I, Essers J, Buhrer C, Bittrich HJ, Roll C, Hohn T, Ehrhardt H, Boettger R, Korner HT, Stein A, Neuberger P, Henriksen TB, Greisen G, Poets CF; ETTNO Investigators. Effects of liberal versus restrictive transfusion strategies on intermittent hypoxaemia in extremely low birthweight infants: secondary analyses of the ETTNO randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2025 Oct 17;110(6):564-570. doi: 10.1136/archdischild-2024-327643.
PMID: 40139741DERIVEDRadford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PMID: 38780066DERIVEDCarson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PMID: 34932836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel R Franz, MD
University Hospital of Tuebingen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinating Investigator
Study Record Dates
First Submitted
July 12, 2011
First Posted
July 13, 2011
Study Start
July 1, 2011
Primary Completion
April 30, 2017
Study Completion
October 31, 2018
Last Updated
September 16, 2021
Record last verified: 2021-09