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Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants (ETTNO)

This study is currently recruiting participants.
Verified January 2013 by University Hospital Tuebingen
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01393496
First received: July 12, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

To compare the effect of restrictive versus liberal red blood cell transfusion thresholds on long-term neurodevelopmental outcome in extremely low birth weight infants.


Condition Intervention Phase
Anemia of Prematurity
 Other: red blood cell transfusion
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants (ETTNO)- a Blinded Randomized Controlled Multicenter Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Incidence of death or major neurodevelopmental impairment [ Time Frame: 24 months of age corrected for prematurity ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 920
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: "liberal" transfusion triggers
"liberal" guidelines for red blood cell transfusions
 Other: red blood cell transfusion
Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants
Active Comparator: "restrictive" transfusion triggers
"restrictive" guidelines for red blood cell transfusions
 Other: red blood cell transfusion
Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants

Detailed Description:

Extremely low birth weight (ELBW) infants uniformly develop anemia of prematurity and frequently require multiple red blood cell transfusions (RBCT) during neonatal intensive care. The criteria currently applied to indicate RBCT in this population are based on expert opinion rather than evidence and conclusive data of long-term effects of RBCT practices do not exist. Both, giving RBCT to improve oxygen carrying capacity and restricting RBCT to avoid RBCT associated risks and costs potentially impair long-term development. The proposed blinded randomized controlled trial was designed and will be powered to compare the effect of restrictive versus liberal red blood cell transfusion guidelines on long-term neurodevelopmental outcome in ELBW infants. ELBW infants will be randomized to receive RBCT according to liberal or restrictive RBCT guidelines, which both reflect current practice in Germany and aim for a clinically relevant difference in mean hemoglobin concentrations. The primary outcome measure is the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity. Key secondary outcomes are the incidences of individual components of the composite primary outcome, the mental and physical developmental index scores of the Bayley Scales of Infant Development (II edition), and growth. Safety analyses will assess the incidences of all major diseases of prematurity. The results of this trial may help to improve the quality of life of these patients and reduce long-term health care costs.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants with a birth weight of 400 - 999g

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393496

Contacts
Contact: Axel R Franz, MD +49707129-0 ext 82211 axel.franz@med.uni-tuebingen.de

Locations
Denmark
Neonatalklinikken Recruiting
Copenhagen, Denmark, 2100
Contact: Jes Reinholdt, MD         jes.reinholdt@regionh.dk    
Principal Investigator: Jes Reinholdt, MD            
Germany
University Hospital of Aachen Recruiting
Aachen, Germany, 52074
Contact: Mark Schoberer, MD     ++49-241 80 88752     mschoberer@ukaachen.de    
Principal Investigator: Mark Schoberer, MD            
Children's Hospital Recruiting
Augsburg, Germany, 86156
Contact: Gernot Buheitel, MD     ++49-821-4003431     gernot.buheitel@klinikum-augsburg.de    
Principal Investigator: Gernot Buheitel, MD            
Vivantes Children's Hospital Recruiting
Berlin, Germany, 12351
Contact: Rainer Rossi, MD     ++49-30-130148270     rainer.rossi@vivantes.de    
Principal Investigator: Rainer Rossi, MD            
Charité University Children's Hospital Recruiting
Berlin, Germany, 13353
Contact: Christoph Buehrer, MD     ++49-30 4505-66122     christoph.buehrer@charite.de    
Principal Investigator: Christoph Buehrer, MD            
University Children's Hospital Recruiting
Bochum, Germany, 44791
Contact: Norbert Teig, MD     ++49-234-612632     norbert.teig@ruhr-uni-bochum.de    
Principal Investigator: Norbert Teig, MD            
Children's Hospital Not yet recruiting
Cologne, Germany, 50375
Contact: Marc Hoppenz, MD         hoppenzm@kliniken-koeln.de    
Principal Investigator: Marc Hoppenz, MD            
University Children's Hospital Recruiting
Cologne, Germany, 50924
Contact: Angela Kribs, MD         angela.kribs@uk-koeln.de    
Principal Investigator: Angela Kribs, MD            
Children's Hospital Recruiting
Datteln, Germany, 45711
Contact: Claudia Roll, MD     ++49-2363-975-227     c.roll@kinderklinik-datteln.de    
Principal Investigator: Claudia Roll, MD            
University Children's Hospital Recruiting
Dresden, Germany, 01307
Contact: Mario Ruediger, MD         mario.ruediger@uniklinikum-dresden.de    
Principal Investigator: Violeta Ojinaga, MD            
University of Duesseldorf Recruiting
Duesseldorf, Germany, 40225
Contact: Thomas Hoehn, MD         Thomas.Hoehn@uni-duesseldorf.de    
Principal Investigator: Thomas Hoehn, MD            
Helios Children's Hospital Not yet recruiting
Erfurt, Germany, 99089
Contact: Hans-Joerg Bittrich, MD     ++49-361-781-72733     hans-joerg.bittrich@helios-kliniken.de    
Principal Investigator: Hans-Joerg Bittrich, MD            
Children's Hospital Recruiting
Erlangen, Germany, 91054
Contact: Hans-Georg Topf, MD     ++49-9131-8536813     hans-georg.topf@uk-erlangen.de    
Principal Investigator: Michael Schroth, MD            
University Children's Hospital Recruiting
Essen, Germany, 45122
Contact: Anja Stein, MD     ++49-201-7233350     anja.stein@uk-essen.de    
Principal Investigator: Anja Stein, MD            
University Children's Hospital Recruiting
Frankfurt, Germany, 60590
Contact: Doris Fischer, MD     ++49-69-63015249     doris.fischer@kgu.de    
Principal Investigator: Horst Buxmann, MD            
University Children's Hospital Recruiting
Giessen, Germany, 35385
Contact: Dirk Faas, MD     ++49-641/985-43400     dirk.faas@paediat.med.uni-giessen.de    
Principal Investigator: Matthias Heckmann, MD            
University of Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Matthias Heckmann, MD         matthias.heckmann@uni-greifswald.de    
Principal Investigator: Matthias Heckmann, MD            
Children's Hospital Altona Not yet recruiting
Hamburg, Germany, 22763
Contact: Axel von der Wense, MD     ++49-40-88908-212     axel.wense@kinderkrankenhaus.net    
Principal Investigator: Axel von der Wense, MD            
Children's Hospital Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Sarah Kabisch     ++49-1522-2816620     s.kabisch@uke.uni-hamburg.de    
Principal Investigator: Sarah Kabisch            
Children's Hospital Recruiting
Hannover, Germany, 30625
Contact: Bettina Bohnhorst, MD     ++49-511-532-9124     bohnhorst.bettina@mh-hannover.de    
Principal Investigator: Bettina Bohnhorst, MD            
University Hospital of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Ulrich H. Thome, MD     +49-341-97-26020     ulrich.thome@medizin.uni-leipzig.de    
Principal Investigator: Ulrich H. Thome, MD            
University of Luebeck Recruiting
Luebeck, Germany, 23538
Contact: Wolfgang Goepel, MD         goepel@paedia.ukl.mu-luebeck.de    
Principal Investigator: Wolfgang Goepel, MD            
University Children's Hospital Recruiting
Magdeburg, Germany, 39120
Contact: Stefan Avenarius, MD     ++49-391-6224100     stefan@avenarius.com    
Principal Investigator: Stefan Avenarius, MD            
University Hospital of Marburg Recruiting
Marburg, Germany, 35033
Contact: Rolf F Maier, MD     +4964215866229     rolf.maier@med.uni-marburg.de    
Principal Investigator: Rolf F Maier, MD            
University Children's Hospital Recruiting
Muenster, Germany, 48149
Contact: Georg Rellensmann, MD     ++49-251-83-49760     g.rellensmann@uni-muenster.de    
Principal Investigator: Georg Rellensmann, MD            
University Children's Hospital Recruiting
Munich, Germany, 80337
Contact: Larissa Maenhardt, MD     ++49-89-51604111     larissa.maenhardt@med.uni-muenchen.de    
Principal Investigator: Claudia F. Nussbaum, MD            
Children's Hospital Recruiting
Nuremberg, Germany, 90471
Contact: Jan-Holger Schiffmann, MD     ++49-911-3982276     kijuklinik@klinikum-nuernberg.de    
Principal Investigator: Jan-Holger Schiffmann, MD            
Children's Hospital St. Hedwig Recruiting
Regensburg, Germany, 93049
Contact: Hugo Segerer, MD     ++49-941-369-5401     hugo.segerer@barmherzige-regensburg.de    
Principal Investigator: Hugo Segerer, MD            
DRK Kinderklinik Recruiting
Siegen, Germany, 57072
Contact: Rainer Burghard, MD         mechthild.hubert@gmx.de    
Principal Investigator: Rainer Burghard, MD            
Children's Hospital Recruiting
Stuttgart, Germany, 70176
Contact: Matthias Vochem, MD     ++49-711-278-72451     m.vochem@klinikum-stuttgart.de    
Principal Investigator: Matthias Vochem, MD            
University Hospital of Tuebingen Recruiting
Tuebingen, Germany, 72076
Contact: Axel R Franz, MD     +49707129-0 ext 82211     axel.franz@med.uni-tuebingen.de    
Principal Investigator: Axel R Franz, MD            
University Children's Hospital Recruiting
Ulm, Germany, 89075
Contact: Reinhard Hopfner, MD     ++49-731-50057311     reinhard.hopfner@uniklinik-ulm.de    
Principal Investigator: Reinhard Hopfner, MD            
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
Principal Investigator: Axel R Franz, MD University Hospital of Tuebingen
  More Information

Publications:

Responsible Party: Axel Franz, Coordinating Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01393496     History of Changes
Other Study ID Numbers: DFG Fr 1455/6-1, 2010-021576-28
Study First Received: July 12, 2011
Last Updated: January 15, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital Tuebingen:
prematurity
anemia
transfusion

Additional relevant MeSH terms:
Anemia
Birth Weight
Anemia, Neonatal
Infant, Premature, Diseases
 Hematologic Diseases
Body Weight
Signs and Symptoms
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013