Abstract | BACKGROUND: METHODS/DESIGN: The ALBINO trial is an investigator-initiated, randomized, placebo-controlled, double-blinded, multi-national parallel group comparison for superiority investigating the effect of allopurinol in (near-)term infants with neonatal HIE. Primary endpoint is long-term outcome determined as survival with neurodevelopmental impairment versus death versus non-impaired survival at 2 years. RESULTS: The primary analysis with three mutually exclusive responses (healthy, death, composite outcome for impairment) will be on the intention-to-treat (ITT) population by a generalized logits model according to Bishop, Fienberg, Holland (Bishop YF, Discrete Multivariate Analysis: Therory and Practice, 1975) and ."will be stratified for the two treatment groups. DISCUSSION: The statistical analysis for the ALBINO study was defined in detail in the study protocol and implemented in this statistical analysis plan published prior to any data analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT03162653. Registered on 22 May 2017.
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Authors | Corinna Engel, Mario Rüdiger, Manon J N L Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Roselinda van der Vlught, Axel R Franz, ALBINO Study Group |
Journal | Trials
(Trials)
Vol. 25
Issue 1
Pg. 81
(Jan 24 2024)
ISSN: 1745-6215 [Electronic] England |
PMID | 38267942
(Publication Type: Randomized Controlled Trial, Multicenter Study, Clinical Trial, Phase III, Journal Article)
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Copyright | © 2024. The Author(s). |
Chemical References |
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Topics |
- Child
- Infant
- Infant, Newborn
- Humans
- Hypoxia-Ischemia, Brain
(diagnosis, therapy)
- Allopurinol
(adverse effects)
- Control Groups
- Brain Injuries
- Hypothermia, Induced
(adverse effects)
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