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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03181646 |
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Date of registration:
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05/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
citicoline |
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Scientific title:
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Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy |
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Date of first enrolment:
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June 15, 2017 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03181646 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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arshad khushdil, FCPS |
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Address:
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Telephone:
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03463300030 |
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Email:
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drarshad104589@yahoo.com |
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Affiliation:
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Name:
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arshad khushdil, FCPS |
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Address:
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Telephone:
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03463300030 |
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Email:
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drarshad104589@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- • Newborn babies having grade 2 and 3 HIE, of both genders delivered in labor room or
operation theatre of our hospital.
- Outdoor patients presenting within 24 hours of delivery
Exclusion Criteria:
- • Outborn babies presenting after 24 hours of delivery.
- Patients with severe congenital malformations
- Babies born extremely prematurely (less than 28 weeks)
Age minimum:
N/A
Age maximum:
14 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoxic-Ischemic Encephalopathy
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Intervention(s)
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Drug: citicoline
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Primary Outcome(s)
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discharge time
[Time Frame: 06 months after start of study]
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effect on sucking
[Time Frame: 06 months after start of study]
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effect on seizures
[Time Frame: 06 months after start of study]
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Secondary ID(s)
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CITICOLINE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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