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Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Primary Purpose

Perinatal Asphyxia

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Erythropoietin
Sponsored by
Sheri Kashmir Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Asphyxia focused on measuring Perinatal asphyxia, erythropoietin

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheri-Kashmir Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

erythropoietin, perinatal asphyxia,

Normal saline, perinatal asphyxia

Arm Description

Treatment group

Normal saline on alternate days for 5 doses starting from first 6 hours of life

Outcomes

Primary Outcome Measures

Death or moderate or severe disability at 18-22 months of age

Secondary Outcome Measures

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.
Bayley psychomotor development index
Hearing loss at 18-22 months

Full Information

First Posted
November 27, 2013
Last Updated
October 12, 2016
Sponsor
Sheri Kashmir Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02002039
Brief Title
Neuroprotective Role of Erythropoietin in Perinatal Asphyxia
Official Title
Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheri Kashmir Institute of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
Detailed Description
will be a randomized trial

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Asphyxia
Keywords
Perinatal asphyxia, erythropoietin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erythropoietin, perinatal asphyxia,
Arm Type
Active Comparator
Arm Description
Treatment group
Arm Title
Normal saline, perinatal asphyxia
Arm Type
Placebo Comparator
Arm Description
Normal saline on alternate days for 5 doses starting from first 6 hours of life
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
erhthropoietin beta
Intervention Description
500 units /kg /day every other day for 5 doses
Primary Outcome Measure Information:
Title
Death or moderate or severe disability at 18-22 months of age
Time Frame
18-22 months
Secondary Outcome Measure Information:
Title
Disability
Description
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.
Time Frame
18-22 months
Title
Bayley psychomotor development index
Time Frame
18-22 months months
Title
Hearing loss at 18-22 months
Time Frame
18-22 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feroz Shaheen, MD
Organizational Affiliation
SKIMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Prof. WAjid Ali
Organizational Affiliation
SKIMS
Official's Role
Study Director
Facility Information:
Facility Name
Sheri-Kashmir Institute of Medical Sciences
City
Srinagar
State/Province
Jammu and kashmir
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

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