Neuroprotective Role of Erythropoietin in Perinatal Asphyxia
- Registration Number
- NCT02002039
- Lead Sponsor
- Sheri Kashmir Institute of Medical Sciences
- Brief Summary
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
- Detailed Description
will be a randomized trial
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period
Exclusion Criteria
- Babies with congenital malformations
- Small for gestational age babies
- Babies with chromosomal anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description erythropoietin, perinatal asphyxia, Erythropoietin Treatment group Normal saline, perinatal asphyxia Erythropoietin Normal saline on alternate days for 5 doses starting from first 6 hours of life
- Primary Outcome Measures
Name Time Method Death or moderate or severe disability at 18-22 months of age 18-22 months
- Secondary Outcome Measures
Name Time Method Bayley psychomotor development index 18-22 months months Hearing loss at 18-22 months 18-22 months Disability 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.
Trial Locations
- Locations (1)
Sheri-Kashmir Institute of Medical Sciences
🇮🇳Srinagar, Jammu and kashmir, India