Overview

This trial is active, not recruiting.

Condition anemia of prematurity
Treatments red blood cell transfusion
Phase phase 4
Sponsor University Hospital Tuebingen
Collaborator German Research Foundation
Start date July 2011
End date April 2017
Trial size 920 participants
Trial identifier NCT01393496, 2010-021576-28, DFG Fr 1455/6-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
"liberal" guidelines for red blood cell transfusions
red blood cell transfusion
Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants
(Active Comparator)
"restrictive" guidelines for red blood cell transfusions
red blood cell transfusion
Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants

Primary Outcomes

Measure
Incidence of death or major neurodevelopmental impairment
time frame: 24 months of age corrected for prematurity

Eligibility Criteria

Male or female participants up to 3 days old.

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

Additional Information

Official title Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants (ETTNO)- a Blinded Randomized Controlled Multicenter Trial
Principal investigator Axel R Franz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by University Hospital Tuebingen.