Clinical Trial: Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

Brief Summary: Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.

Detailed Summary: will be a randomized trial
Sponsor: Sheri Kashmir Institute of Medical Sciences

Current Primary Outcome: Death or moderate or severe disability at 18-22 months of age [ Time Frame: 18-22 months ]

Original Primary Outcome: Death and or disability at 12-18 months of life [ Time Frame: 12-18 months after birth ]

Neurological outcomes including cerebral palsy, any gross motor delay, Hearing impairment


Current Secondary Outcome:

  • Disability [ Time Frame: 18-22 months ]
    Severe disability was defined as GMFCS grade of level 3-5, hearing impairment requiring hearing aids, bilateral cortical visual impairment with no useful vision or Bayley Mental Development Index Score less than 70. Moderate disability was defined as Bayley Mental Developmental Index Score between 70-84 and any one of the following criteria: GMFCS grade of level 2, hearing impairment with no amplification or persistent seizure disorder.
  • Bayley psychomotor development index [ Time Frame: 18-22 months months ]
  • Hearing loss at 18-22 months [ Time Frame: 18-22 months ]


Original Secondary Outcome: Gross motor delay [ Time Frame: 12-18 months ]

Information By: Sheri Kashmir Institute of Medical Sciences

Dates:
Date Received: November 27, 2013
Date Started: June 2012
Date Completion:
Last Updated: October 12, 2016
Last Verified: October 2016