Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Perinatal Asphyxia Clinical Trial

Official title:

Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002039
• Other study ID #: Erythropoietin 01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 27, 2013
• Last updated: October 12, 2016
• Start date: June 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

will be a randomized trial

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Perinatal Asphyxia

Intervention

Drug:
• Erythropoietin
500 units /kg /day every other day for 5 doses

Locations

Country	Name	City	State
India	Sheri-Kashmir Institute of Medical Sciences	Srinagar	Jammu and kashmir

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or moderate or severe disability at 18-22 months of age		18-22 months	No
Secondary	Disability	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.	18-22 months	No
Secondary	Bayley psychomotor development index		18-22 months months	No
Secondary	Hearing loss at 18-22 months		18-22 months	No