CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,013 enrolled
Drug / intervention
red blood cell transfusion +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01393496
NCT01393496Phase 4Completed

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

University Hospital Tuebingen·interventional·Posted Jul 13, 2011·Updated Sep 16, 2021

In Brief

A Phase 4 clinical trial evaluating red blood cell transfusion for Anemia of Prematurity. Completed, enrolled 1,013 participants across 32 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Germany

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2011
Enrollment StartJul 1, 2011
Primary CompletionApr 30, 2017
Study CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.0 years ago

Interventions

red blood cell transfusionother

Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants

red blood cell transfusionother

Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants