Citicoline in hypoxic ischemic encephalopathy in neonates: a randomized controlled trial

Abeer Salamah; Doaa El Amrousy; Mai Elsheikh; Mostafa Mehrez

doi:10.1186/s13052-023-01452-5

Citicoline in hypoxic ischemic encephalopathy in neonates: a randomized controlled trial

Ital J Pediatr. 2023 May 12;49(1):55. doi: 10.1186/s13052-023-01452-5.

Authors

Abeer Salamah¹, Doaa El Amrousy², Mai Elsheikh³, Mostafa Mehrez³

Affiliations

¹ Pediatric Department, Kafr Elsheikh University, Kafr Elsheikh, Egypt.
² Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt. doaa.moha@med.tanta.edu.eg.
³ Pediatric Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Abstract

Background: Hypoxic-ischemic encephalopathy (HIE) is one of the major complications that can lead to death or disability in neonates. We assessed the effect of citicoline as a neuroprotector in neonates with moderate and severe HIE.

Methods: This clinical trial was carried on 80 neonates with moderate to severe HIE who were not candidates for therapeutic cooling. They were subdivided randomly into two groups; citicoline treatment group which included 40 neonates who received citicoline 10 mg / kg /12 h IV for 4 weeks plus other supportive measures and the control group which included 40 neonates who were managed with placebo and the same supportive measures. All patients were evaluated for duration of mechanical ventilation (MV), need for inotropes, seizures (type, frequency, and duration), and duration of NICU. Cranial ultrasounds and brain magnetic resonance image (MRI) were performed for all included neonates after 4 weeks of treatment. Follow- ups of all neonates for the neurodevelopmental outcomes were done at 3, 6, 9, and 12 months.

Results: There was a significant reduction in the number of neonates having seizures after discharge in the citicoline-treated group (2 neonates) compared to the control group (11 neonates). Cranial ultrasound and MRI findings at 4 weeks were significantly better in the treatment group compared to the control group. Moreover, neurodevelopmental outcome showed significant improvement at 9 and 12 months in the citicoline treated neonates compared to the control group. There was statistically significant reduction in the duration of seizures, NICU stay, inotrope use, and MV in the treatment group compared to the control group. Citicoline was well tolerated with no remarkable side effects.

Conclusion: Citicoline could be a promising neuroprotector drug in neonates with HIE.

Trial registration: The study was registered at ClinicalTrials.gov (NCT03949049). Registered at 14 May 2019, https://clinicaltrials.gov/ct2/show/NCT03949049.

Keywords: Citicoline; Hypoxic ischemic encephalopathy; Neonates; Neurodevelopmental outcomes; Seizures.

Publication types

Randomized Controlled Trial

MeSH terms

Brain / pathology
Cytidine Diphosphate Choline / therapeutic use
Humans
Hypothermia, Induced*
Hypoxia-Ischemia, Brain* / complications
Infant, Newborn
Magnetic Resonance Imaging
Seizures / therapy

Substances

Cytidine Diphosphate Choline

Associated data

ClinicalTrials.gov/NCT03949049