MedDataX Logo

Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

NCT ID: NCT00624871

Last Updated: 2008-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxic Ischemic Encephalopathy Perinatal Asphyxia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Interleukin 1-beta Interleukin 6 Vitamin C HIE neonates

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

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

Group Type ACTIVE_COMPARATOR

Ascorbic acid (vitamin C)

Intervention Type DRUG

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

Ibuprofen

Intervention Type DRUG

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

B

Infants will receive equivalent amount of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ascorbic acid (vitamin C)

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

Intervention Type DRUG

Ibuprofen

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Al-Azhar University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed Elsayed, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Laila Abd-Rabboh, MD

Role: STUDY_CHAIR

Al-Azhar University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bab El-Shariya Hospital

Cairo, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004-MD-thesis-ahmed

Identifier Type: -

Identifier Source: org_study_id