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Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02002039
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Perinatal Asphyxia Drug: Erythropoietin Phase 2 Phase 3

Detailed Description:
will be a randomized trial

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial
Study Start Date : June 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: erythropoietin, perinatal asphyxia,
Treatment group
Drug: Erythropoietin
500 units /kg /day every other day for 5 doses
Other Name: 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 Name: erhthropoietin beta




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

Secondary Outcome Measures :
  1. 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.

  2. Bayley psychomotor development index [ Time Frame: 18-22 months months ]
  3. Hearing loss at 18-22 months [ Time Frame: 18-22 months ]


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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002039


Locations
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India
Sheri-Kashmir Institute of Medical Sciences
Srinagar, Jammu and kashmir, India
Sponsors and Collaborators
Sheri Kashmir Institute of Medical Sciences
Investigators
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Study Chair: Feroz Shaheen, MD SKIMS
Study Director: Prof. WAjid Ali SKIMS

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Responsible Party: Dr.Mushtaq, Professor, Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT02002039     History of Changes
Other Study ID Numbers: Erythropoietin 01
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr.Mushtaq, Sheri Kashmir Institute of Medical Sciences:
Perinatal asphyxia
erythropoietin

Additional relevant MeSH terms:
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Asphyxia
Asphyxia Neonatorum
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Epoetin Alfa
Hematinics