Effect of Citicoline on Neurological Severity Score and Cerebral Doppler Resistive Index in Neonatal Hypoxic Ischemic Encephalopathy: A Randomized Control Trial

NCT07763145 | Not Yet Recruiting

• 1 other identifier: ASRD 411
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of citicoline in improving cerebral blood flow parameters and neurological status among neonates with hypoxic-ischemic encephalopathy using Doppler resistive index and Sarnat-Sarnat score after 72 hours of therapy.

Conditions

Hypoxic Ischaemic Encephalopathy (HIE)

Outcome Measures

Primary Outcomes (2)

• Sarnat and Sarnat scoring

  enrollment to 72 hours

• Cerebral Resistive Index

  Enrollment to 72 hours

Study Arms (2)

Intervention Group

EXPERIMENTAL

This will receive medicine citicoline with standard care

Drug: Citicoline

Control group

PLACEBO COMPARATOR

Only receive standard care

Other: Standard medical treatment

Interventions

Citicoline DRUG

This group will receive drug and standard care

Intervention Group

Standard medical treatment OTHER

This group will receive only standard care

Control group

Eligibility Criteria

• Age: 0 Hours - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All inborn neonates diagnosed with APGAR score (Table 2) less then 8/10 at 5 min of life presenting to the emergency room within the first day of life.
• Outborn babies admitted in the last 24 hours with history or clinical features of perinatal asphyxia.

You may not qualify if:

• Neonates who have received therapeutic hypothermia
• Neonates with congenital, developmental or chromosomal malformations
• Significant antenatal risk factors leading to early-onset sepsis\\DIC or CNS depression unrelated to asphyxia
• Preterm neonates \<35 weeks
• No consent could be obtained

Sponsors & Collaborators

• Khyber Girls Medical College: lead
• Hayatabad Medical Complex: collaborator

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (7)

• Salamah A, El Amrousy D, Elsheikh M, Mehrez M. 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.

  PMID: 37173784 BACKGROUND

• Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.

  PMID: 20144981 BACKGROUND

• Gerner GJ, Burton VJ, Poretti A, Bosemani T, Cristofalo E, Tekes A, Seyfert D, Parkinson C, Leppert M, Allen M, Huisman TA, Northington FJ, Johnston MV. Transfontanellar duplex brain ultrasonography resistive indices as a prognostic tool in neonatal hypoxic-ischemic encephalopathy before and after treatment with therapeutic hypothermia. J Perinatol. 2016 Mar;36(3):202-6. doi: 10.1038/jp.2015.169. Epub 2015 Nov 26.

  PMID: 26609871 BACKGROUND

• Snyder EJ, Perin J, Chavez-Valdez R, Northington FJ, Lee JK, Tekes A. Head Ultrasound Resistive Indices Are Associated With Brain Injury on Diffusion Tensor Imaging Magnetic Resonance Imaging in Neonates With Hypoxic-Ischemic Encephalopathy. J Comput Assist Tomogr. 2020 Sep/Oct;44(5):687-691. doi: 10.1097/RCT.0000000000001069.

  PMID: 32842070 BACKGROUND

• Hurtado O, Moro MA, Cardenas A, Sanchez V, Fernandez-Tome P, Leza JC, Lorenzo P, Secades JJ, Lozano R, Davalos A, Castillo J, Lizasoain I. Neuroprotection afforded by prior citicoline administration in experimental brain ischemia: effects on glutamate transport. Neurobiol Dis. 2005 Mar;18(2):336-45. doi: 10.1016/j.nbd.2004.10.006.

  PMID: 15686962 BACKGROUND

• Adibhatla RM, Hatcher JF, Dempsey RJ. Citicoline: neuroprotective mechanisms in cerebral ischemia. J Neurochem. 2002 Jan;80(1):12-23. doi: 10.1046/j.0022-3042.2001.00697.x.

  PMID: 11796739 BACKGROUND

• Cohen SS, Sprecher AJ, Acharya KK. Hypoxic-ischemic encephalopathy. In: Kliegman RM, St. Geme JW, Blum NJ, Tasker RC, Wilson KM, Schuh AM, Mack CL, editors. Nelson Textbook of Pediatrics. 22nd ed. Vol 1. Philadelphia: Elsevier; 2024. p. 1062.

  BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Romisa Rehman

  Hyatabad Medical Complex

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romisa Rehman, FCPS, MRCPCH

CONTACT

00923219059305; measa_awan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

PA (1)