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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00624871
Other study ID # 2004-MD-thesis-ahmed
Secondary ID
Status Completed
Phase N/A
First received February 20, 2008
Last updated February 27, 2008
Start date April 2004
Est. completion date April 2006

Study information

Verified date February 2008
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group N/A to 2 Hours
Eligibility Inclusion Criteria:

- Apgar score at 5 minutes < 6

- Profound metabolic or mixed acidosis with pH < 7 in the initial blood gas

- Evidence of encephalopathy such as coma, seizures or hypotonia

- Evidence of multi-system compromise, in addition to encephalopathy

Exclusion Criteria:

- Major congenital anomalies

- Early sepsis

- Gastrointestinal bleeding

- Thrombocytopenia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Ascorbic acid (vitamin C)
IV, 100 mg/kg/day, every day, for 3 days
Ibuprofen
PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
Placebo


Locations

Country Name City State
Egypt Bab El-Shariya Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary DDST-II 6 months No
Primary Neurological Examination 6 months No
Secondary Death On Discharge Yes
Secondary Neurological Examination On Discharge No
See also
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