Volume 83, Issue 10 (January 2025)
Tehran Univ Med J. 2025, 83(10): 730-738 |
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Hajizadeh Saffar F, Mousavi S F, Mohammadzadeh A, Shah Farhat A, Hamidi Alamdari D, Bakhtiari E et al . Effects of oral melatonin on acute respiratory distress syndrome in neonates: a randomized, double-blind, controlled trial. Tehran Univ Med J. 2025; 83 (10) :730-738
URL: http://tumj.tums.ac.ir/article-1-13884-en.html
URL: http://tumj.tums.ac.ir/article-1-13884-en.html
Fatemeh Hajizadeh Saffar1, Seyede Farnaz Mousavi2, Ashraf Mohammadzadeh2, Ahmad Shah Farhat2, Daryoush Hamidi Alamdari3, Elham Bakhtiari4, Ezzat Khodashenas *5
1- Department of Neonatalogy, Faculty of Medicine, Torbat Heydariye University of Medical Sciences, Torbat Heydariye, Iran.
2- Department of Neonatalogy, Neonatal Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3- Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
4- Clinical Research Development Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
5- Department of Neonatalogy, Neonatal Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. ,khodashenase@mums.ac.ir
2- Department of Neonatalogy, Neonatal Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3- Department of Clinical Biochemistry, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
4- Clinical Research Development Unit, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
5- Department of Neonatalogy, Neonatal Research Center, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. ,
Abstract: (22 Views)
Background: Neonatal Acute Respiratory Distress Syndrome (RDS), also known as Surfactant Deficiency Disorder (SDD) and formerly Hyaline Membrane Disease (HMD), predominantly affects preterm neonates and is primarily a consequence of pulmonary immaturity. It remains a significant challenge in global neonatal care. Recent research has shed light on the potential therapeutic benefits of melatonin, particularly due to its antioxidant and anti-inflammatory properties. Recognized for its strong radical-scavenging activity, melatonin can neutralize various harmful oxygen-derived reactants, making it a potent endogenous antioxidant. This quality is especially relevant in pulmonary disorders, where oxidative stress and inflammation play critical roles The role of melatonin in RDS management is not well established.
Methods: This double-blind, randomized clinical trial at Emam Reza Hospital, a tertiary center in Mashhad, Iran, enrolled 74 neonates diagnosed with RDS between 2022 and 2023. Participants, aged 1 to 30 days, were randomly assigned to receive either oral melatonin (10 mg/kg per day for three days) alongside standard treatment or standard treatment alone. The outcomes were Prooxidant-Antioxidant Balance (PAB) levels and C-reactive protein (CRP) levels, and severity based on RDS grading measured on the first- and third-days post-birth.
Results: The study demonstrated a significant reduction in PAB levels in the melatonin-treated group, indicating a reduction in oxidative stress. However, melatonin did not significantly impact CRP levels or distress grades. The logistic regression analysis adjusted for surfactant dosee confirmed the effect of melatonin on reducing oxidative stress without significantly influencing CRP levels.
Conclusion: Oral melatonin shows potential in reducing oxidative stress in neonates with RDS but has limited effects on inflammation markers and clinical distress grades. Our findings contribute to the growing body of evidence on the therapeutic use of melatonin in neonatal care, underscoring the need for a multifaceted approach in the management of ARDS in this vulnerable population.
Methods: This double-blind, randomized clinical trial at Emam Reza Hospital, a tertiary center in Mashhad, Iran, enrolled 74 neonates diagnosed with RDS between 2022 and 2023. Participants, aged 1 to 30 days, were randomly assigned to receive either oral melatonin (10 mg/kg per day for three days) alongside standard treatment or standard treatment alone. The outcomes were Prooxidant-Antioxidant Balance (PAB) levels and C-reactive protein (CRP) levels, and severity based on RDS grading measured on the first- and third-days post-birth.
Results: The study demonstrated a significant reduction in PAB levels in the melatonin-treated group, indicating a reduction in oxidative stress. However, melatonin did not significantly impact CRP levels or distress grades. The logistic regression analysis adjusted for surfactant dosee confirmed the effect of melatonin on reducing oxidative stress without significantly influencing CRP levels.
Conclusion: Oral melatonin shows potential in reducing oxidative stress in neonates with RDS but has limited effects on inflammation markers and clinical distress grades. Our findings contribute to the growing body of evidence on the therapeutic use of melatonin in neonatal care, underscoring the need for a multifaceted approach in the management of ARDS in this vulnerable population.
Type of Study: Original Article |
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