Version 1
: Received: 10 April 2024 / Approved: 11 April 2024 / Online: 11 April 2024 (07:29:34 CEST)
How to cite:
Jerez-Calero, A.; Contreras-Chova, F.; Benitez-Feliponi, A.; Azaryah, H.; Hurtado-Suazo, J.A.; Moreno-Galdó, M.F.; Molina-Carballo, A. Pro-Inflammatory Biomarkers and Long Term Neurological Outcomes in Hypothermia Plus Melatonin Treated Newborns. A Pilot Clinical Trial. Preprints2024, 2024040777. https://doi.org/10.20944/preprints202404.0777.v1
Jerez-Calero, A.; Contreras-Chova, F.; Benitez-Feliponi, A.; Azaryah, H.; Hurtado-Suazo, J.A.; Moreno-Galdó, M.F.; Molina-Carballo, A. Pro-Inflammatory Biomarkers and Long Term Neurological Outcomes in Hypothermia Plus Melatonin Treated Newborns. A Pilot Clinical Trial. Preprints 2024, 2024040777. https://doi.org/10.20944/preprints202404.0777.v1
Jerez-Calero, A.; Contreras-Chova, F.; Benitez-Feliponi, A.; Azaryah, H.; Hurtado-Suazo, J.A.; Moreno-Galdó, M.F.; Molina-Carballo, A. Pro-Inflammatory Biomarkers and Long Term Neurological Outcomes in Hypothermia Plus Melatonin Treated Newborns. A Pilot Clinical Trial. Preprints2024, 2024040777. https://doi.org/10.20944/preprints202404.0777.v1
APA Style
Jerez-Calero, A., Contreras-Chova, F., Benitez-Feliponi, A., Azaryah, H., Hurtado-Suazo, J.A., Moreno-Galdó, M.F., & Molina-Carballo, A. (2024). Pro-Inflammatory Biomarkers and Long Term Neurological Outcomes in Hypothermia Plus Melatonin Treated Newborns. A Pilot Clinical Trial. Preprints. https://doi.org/10.20944/preprints202404.0777.v1
Chicago/Turabian Style
Jerez-Calero, A., M. Fernanda Moreno-Galdó and Antonio Molina-Carballo. 2024 "Pro-Inflammatory Biomarkers and Long Term Neurological Outcomes in Hypothermia Plus Melatonin Treated Newborns. A Pilot Clinical Trial" Preprints. https://doi.org/10.20944/preprints202404.0777.v1
Abstract
Objective. To evaluate serum neuronal and inflammatory biomarkers in asphyctic newborns treated with hypothermia alone or hypothermia plus melatonin, and whether biomarkers correlate with neurodevelopmental outcomes.
Design. This is a pilot multicentre, randomised, controlled, double blind clinical trial. Neuronal glial fibrillary acidic protein (GFAP), granulocyte-macrophage colony-stimulating factor (GM-CSF), and inflammatory cytokines (interleukin (IL)-1, IL-2, IL-7 and IL-13) were measured in serum samples at hospital admission (T0), 24 hours (T1), 72 hours (T2) and 7-10 days of age (T3). Neurodevelopmental outcomes (Bayley Scales of Infant and Toddler Development-III scales, Gross Motor Function Classification System (GMFCS) and the Tardieu scale) were performed at 6 and 18 months. Setting: Level 3 neonatal intensive care unit. Patients and interventions: 25 newborns were recruited. The treated patients received a daily dose of intravenous melatonin, 5 mg per kg body weight, for 3 days.
Results. After adjusting the data for severity, in the group treated with melatonin, there is a decrease in plasma levels of GM-CSF, IL-2 and IL-13 at T1 compared to placebo, as well as, at T2, in GM-CSF concentrations, as well as IL-7 and IL-13 at T3. Evolutionarily, we found a significant decrease in GM-CSF concentrations in the treatment group compared to placebo, with no differences for the rest of the biomarkers. It is noteworthy that the sustained decrease in GM-CSF and inflammatory cytokines IL-2, IL-7 and IL-13 correlated with better neurodevelopmental outcomes at 6 and 18 months.
Conclusions. In neonates with hypoxic-ischemic encephalopathy, the addition of iv melatonin to hypothermia therapy affects the plasma concentration of biomarkers in the first week of life, with a high correlation with long-term neurological prognosis.
Medicine and Pharmacology, Pediatrics, Perinatology and Child Health
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
