Poryo, Martin and Gortner, Ludwig and Bay, Johannes and Franz, Axel R. and Ehrhardt, Harald and Klein, Lars and Behnke, Judith and Frodermann, Tina and Petzinger, Jutta and Binder, Christoph and Kirschenhofer, Susanne and Huning, Britta and Stein, Anja and Heep, Axel and Cloppenburg, Eva and Muyimbwa, Julia and Ott, Torsten and Sandkotter, Julia and Teig, Norbert and Wiegand, Susanne and Schroth, Michael and Kick, Andrea and Wurm, Donald and Gebauer, Corinna and Linnemann, Knud and Kittel, Jochen and Wieg, Christian and Kiechl-Kohlendorfer, Ursula and Schmidt, Susanne and Bottger, Ralf and Thomas, Wolfgang and Nunez, Francisco Brevis and Stockmann, Antje and Kriebel, Thomas and Muller, Andreas and Klotz, Daniel and Morhart, Patrick and Nohr, Donatus and Biesalski, Hans Konrad and Giannopoulou, Eleni Z. and Hilt, Susanne and Wagenpfeil, Stefan and Haiden, Nadja and Rysavy, Matthew and Hartel, Christoph and Ruckes, Christian and Ehrlich, Anne and Meyer, Sascha (2025) Two-year outcomes after early postnatal high-dose fat-soluble enteral vitamin A supplementation in extremely low birth weight infants: follow-up of the NeoVitaA randomized controlled trial. ECLINICALMEDICINE, 89: 103495. ISSN , 2589-5370
Full text not available from this repository. (Request a copy)Abstract
Background The longer-term effects of early high-dose vitamin A to support lung development in preterm infants remain to be clarified. The aim of the NeoVitaA follow-up study was to assess the effects of early postnatal additional high-dose fat-soluble enteral vitamin A supplementation (HD-VitA) vs. placebo (control) for 28 days on respiratory complications and neurodevelopmental outcome in ELBW infants receiving recommended basic vitamin A supplementation, specified as secondary outcome parameters in the NeoVitaA trial. Methods The trial was approved by the ethics committee of Saarland, Saarbruecken, Germany (file number: 70/ 2011) as well as by all local ethics committees and the Bundesinstitut f & uuml;r Arzneimittel und Medizinprodukte (BfArM, Bonn, Germany). The NeoVitaA trial was registered with EudraCT (2013-001998-24) and DRKS (DRKS00006541). This follow-up covers secondary endpoints at 12 and 24 months as mentioned in the registration. Follow-up took place between September 2019 and June 2024. Follow-up assessment at 12 and 24 months' corrected age (CA) of infants enrolled in the NeoVitaA-trial included anthropometric data, number of antibiotic treatments, antibiotic treatments for pulmonary infections, hospital admissions, and hospital admissions for pulmonary infections, composite scores of the Bayley Scale of Infant and Toddler Development, second (Bayley-II) or third edition (Baley-III), other medical diagnoses and medical treatments. Findings Follow-up examinations were available for 759 infants (83.0%). HD-VitA had no effect on number of antibiotics needed for pulmonary infections or number of hospital admissions for pulmonary infections at 12 or 24 months' CA. At 24 months' CA, the median number of antibiotic courses for pulmonary infections was one for both the HD-VitA and control group; the median number of hospital admissions for pulmonary infections per patient was 0 (HD-VitA) and 1 (control). Successful Bayley assessment was completed in 618/759 infants (92 Bayley-II, 526 Bayley-III). The median Mental Development Index score for Bayley-II was 95 vs. 97 (median difference-5.0, 95%-CI [-12.0, 2.0]) and Psychomotor Development Index 96 vs. 92 (median difference 3.0, 95%-CI [-4.0, 8.0]), with intervention and placebo, respectively. The median cognitive composite score for Bayley-III was 95 vs. 95 (median difference 0.0, 95%-CI [-5.0, 0.0]) and motor score was 92 vs. 92 (median difference 0.0, 95%-CI [-4.0, 3.0]), respectively. Interpretation Early postnatal high-dose enteral fat-soluble vitamin A supplementation in ELBW infants did not affect pulmonary or developmental outcomes at 24 months' CA. Funding The NeoVitaA trial was funded by the Deutsche Forschungsgemeinschaft ME 3827/1-1/2 and European Clinical Research Infrastructures Network. Copyright (c) 2025 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | BRONCHOPULMONARY DYSPLASIA; PRETERM INFANTS; CEREBRAL-PALSY; PREVENT; Bayley-II; Bayley-III; Bronchopulmonary dysplasia; Death; Extremely low birth weight infants; Neurodevelopmental outcome; Respiratory outcome; Vitamin A |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Kinder- und Jugendmedizin |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2026 13:18 |
| Last Modified: | 24 Mar 2026 13:18 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68062 |
Actions (login required)
 |
View Item |
