Effect of Citicoline on Neurological Severity Score and Cerebral Doppler Resistive Index in Neonatal Hypoxic Ischemic Encephalopathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-24
SponsorKhyber Girls Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Citicoline

    Drug

    This group will receive drug and standard care

  • Standard medical treatment

    Other intervention

    This group will receive only standard care

Treatment groups

86 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sarnat and Sarnat scoring

Time frame
enrollment to 72 hours
2

Cerebral Resistive Index

Time frame
Enrollment to 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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Khyber Girls Medical College

Lead sponsor

Hayatabad Medical Complex

Collaborator

This trial is not recruiting at the moment. You can still explore other options: