NCT00624871

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

2 years

First QC Date

February 20, 2008

Last Update Submit

February 27, 2008

Conditions

Hypoxic Ischemic EncephalopathyPerinatal Asphyxia

Keywords

Interleukin 1-betaInterleukin 6Vitamin CHIEneonates

Outcome Measures

Primary Outcomes (2)

  • DDST-II

    6 months

  • Neurological Examination

    6 months

Secondary Outcomes (2)

  • Death

    On Discharge

  • Neurological Examination

    On Discharge

Study Arms (2)

A

ACTIVE COMPARATOR

Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days

Drug: Ascorbic acid (vitamin C)Drug: Ibuprofen

B

PLACEBO COMPARATOR

Infants will receive equivalent amount of placebo

Drug: Placebo

Interventions

Ascorbic acid (vitamin C)DRUG

IV, 100 mg/kg/day, every day, for 3 days

A
IbuprofenDRUG

PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life

A
PlaceboDRUG
B

Eligibility Criteria

AgeUp to 2 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Major congenital anomalies
  • Early sepsis
  • Gastrointestinal bleeding
  • Thrombocytopenia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bab El-Shariya Hospital

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Ascorbic AcidIbuprofen

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesPhenylpropionatesAcids, Carbocyclic

Study Officials

  • Ahmed Elsayed, MD

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • Laila Abd-Rabboh, MD

    Al-Azhar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2008

First Posted

February 28, 2008

Study Start

April 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

February 28, 2008

Record last verified: 2008-02

Locations

EG(1)