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

NCT01393496 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1013

Last updated 2021-09-16

No results posted yet for this study

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.

Conditions

  • Anemia of Prematurity

Interventions

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

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Axel R Franz, MD · University Hospital of Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2017-04-30
Completion
2018-10-31

Countries

  • Denmark
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01393496 on ClinicalTrials.gov