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

This study is ongoing, but not recruiting participants.
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 19, 2015
Last verified: January 2015
  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:


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: April 2017
Estimated Primary Completion Date: April 2017 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393496

Locations
Denmark
Neonatalklinikken
Copenhagen, Denmark, 2100
Germany
University Hospital of Aachen
Aachen, Germany, 52074
Children's Hospital
Augsburg, Germany, 86156
Charité University Children's Hospital
Berlin, Germany, 13353
Vivantes Children's Hospital
Berlin, Germany, 12351
University Children's Hospital
Bochum, Germany, 44791
Children's Hospital
Cologne, Germany, 50375
University Children's Hospital
Cologne, Germany, 50924
Children's Hospital
Datteln, Germany, 45711
University Children's Hospital
Dresden, Germany, 01307
University of Duesseldorf
Duesseldorf, Germany, 40225
Helios Children's Hospital
Erfurt, Germany, 99089
Children's Hospital
Erlangen, Germany, 91054
University Children's Hospital
Essen, Germany, 45122
University Children's Hospital
Frankfurt, Germany, 60590
University Children's Hospital
Giessen, Germany, 35385
University of Greifswald
Greifswald, Germany, 17475
Children's Hospital Altona
Hamburg, Germany, 22763
Children's Hospital Eppendorf
Hamburg, Germany, 20246
Children's Hospital
Hannover, Germany, 30625
University Hospital of Leipzig
Leipzig, Germany, 04103
University of Luebeck
Luebeck, Germany, 23538
University Children's Hospital
Magdeburg, Germany, 39120
University Hospital of Marburg
Marburg, Germany, 35033
University Children's Hospital
Muenster, Germany, 48149
University Children's Hospital
Munich, Germany, 80337
Children's Hospital
Nuremberg, Germany, 90471
Children's Hospital St. Hedwig
Regensburg, Germany, 93049
DRK Kinderklinik
Siegen, Germany, 57072
Children's Hospital
Stuttgart, Germany, 70176
University Hospital of Tuebingen
Tuebingen, Germany, 72076
University Children's Hospital
Ulm, Germany, 89075
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 19, 2015
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by University Hospital Tuebingen:
prematurity
anemia
transfusion

ClinicalTrials.gov processed this record on March 01, 2015