Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Condition(s) targeted: Hypoxic Ischemic Encephalopathy; Perinatal Asphyxia

Intervention: Ascorbic acid (vitamin C) (Drug); Ibuprofen (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Al-Azhar University

Official(s) and/or principal investigator(s):
Ahmed Elsayed, MD, Principal Investigator, Affiliation: Al-Azhar University
Laila Abd-Rabboh, MD, Study Chair, Affiliation: Al-Azhar University

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.

Official title: Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

DDST-II

Neurological Examination

Secondary outcome:

Death

Neurological Examination

Minimum age: N/A. Maximum age: 2 Hours. Gender(s): Both.

Criteria:

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

Bab El-Shariya Hospital, Cairo, Egypt

Starting date: April 2004
Ending date: April 2006
Last updated: February 27, 2008