Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Perinatal Asphyxia
• Intervention / Treatment: Drug: Erythropoietin

Detailed Description

will be a randomized trial

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• India
  • Jammu and kashmir
    • Srinagar, Jammu and kashmir, India
      • Sheri-Kashmir Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: erythropoietin, perinatal asphyxia,; Treatment group	Drug: Erythropoietin; 500 units /kg /day every other day for 5 doses; Other Names: erhthropoietin beta
Placebo Comparator: Normal saline, perinatal asphyxia; Normal saline on alternate days for 5 doses starting from first 6 hours of life	Drug: Erythropoietin; 500 units /kg /day every other day for 5 doses; Other Names: erhthropoietin beta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death or moderate or severe disability at 18-22 months of age	18-22 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bayley psychomotor development index		18-22 months months
Hearing loss at 18-22 months		18-22 months

Collaborators and Investigators

• Sponsor: Sheri Kashmir Institute of Medical Sciences
• Investigators: Study Chair: Feroz Shaheen, MD, SKIMS; Study Director: Prof. WAjid Ali, SKIMS

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: erythropoietin; Perinatal asphyxia
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Infant, Newborn, Diseases; Death; Asphyxia; Asphyxia Neonatorum; Hematinics; Epoetin Alfa
• Other Study ID Numbers: Erythropoietin 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No