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 : September 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anemia of Prematurity | Other: red blood cell transfusion | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1013 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 |

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 |
- 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

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.
Ages Eligible for Study: | 0 Days to 3 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Principal Investigator: | Axel R Franz, MD | University Hospital of Tuebingen |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | September 16, 2021 |
Last Verified: | September 2021 |
prematurity anemia transfusion |
Premature Birth Birth Weight Obstetric Labor, Premature |
Obstetric Labor Complications Pregnancy Complications Body Weight |