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

September 9, 2021 updated by: Axel Franz, University Hospital Tuebingen

Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants (ETTNO)- a Blinded Randomized Controlled Multicenter Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: red blood cell transfusion
Implementation of "restrictive" 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 "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants
Other: red blood cell transfusion
Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of death or major neurodevelopmental impairment
Time Frame: 24 months of age corrected for prematurity
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Axel R Franz, MD, University Hospital Of Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 12, 2011

First Posted (Estimate)

July 13, 2011

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFG Fr 1455/6-1
  • 2010-021576-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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