Trial record 1 of 1 for:
ettno
Effects of Transfusion Thresholds on Neurocognitive Outcome of Extremely Low Birth Weight Infants (ETTNO)
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| ClinicalTrials.gov Identifier: NCT01393496 |
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Recruitment Status :
Completed
First Posted : July 13, 2011
Last Update Posted : December 21, 2018
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Sponsor:
University Hospital Tuebingen
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Axel Franz, University Hospital Tuebingen
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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 |
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.
| 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 |
|---|---|
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Experimental: "liberal" transfusion triggers
"liberal" guidelines for red blood cell transfusions
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Other: red blood cell transfusion
Implementation of "liberal" guidelines for red blood cell transfusions in extremely low birth weight infants |
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Active Comparator: "restrictive" transfusion triggers
"restrictive" guidelines for red blood cell transfusions
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Other: red blood cell transfusion
Implementation of "restrictive" guidelines for red blood cell transfusions in extremely low birth weight infants |
Primary Outcome Measures :
- 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
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| 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 32 study locations
Sponsors and Collaborators
University Hospital Tuebingen
German Research Foundation
Investigators
| Principal Investigator: | Axel R Franz, MD | University Hospital of Tuebingen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | December 21, 2018 |
| Last Verified: | December 2018 |
Keywords provided by Axel Franz, University Hospital Tuebingen:
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prematurity anemia transfusion |
Additional relevant MeSH terms:
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Premature Birth Birth Weight Body Weight |
Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |