Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01393496
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Anemia of Prematurity Other: red blood cell transfusion Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 920 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2011
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393496


Locations
Show Show 32 study locations
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Axel R Franz, MD University Hospital of Tuebingen

Publications:
Layout table for additonal information
Responsible Party: Axel Franz, Coordinating Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01393496    
Other Study ID Numbers: DFG Fr 1455/6-1
2010-021576-28 ( EudraCT Number )
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Keywords provided by Axel Franz, University Hospital Tuebingen:
prematurity
anemia
transfusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Birth Weight
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications