Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

NCT ID: NCT02002039

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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will be a randomized trial

Conditions

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Perinatal Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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erythropoietin, perinatal asphyxia,

Treatment group

Group Type ACTIVE_COMPARATOR

Erythropoietin

Intervention Type DRUG

500 units /kg /day every other day for 5 doses

Normal saline, perinatal asphyxia

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

Group Type PLACEBO_COMPARATOR

Erythropoietin

Intervention Type DRUG

500 units /kg /day every other day for 5 doses

Interventions

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Erythropoietin

500 units /kg /day every other day for 5 doses

Intervention Type DRUG

Other Intervention Names

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erhthropoietin beta

Eligibility Criteria

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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
Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheri Kashmir Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr.Mushtaq

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feroz Shaheen, MD

Role: STUDY_CHAIR

SKIMS

Prof. WAjid Ali

Role: STUDY_DIRECTOR

SKIMS

Locations

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Sheri-Kashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, India

Site Status

Countries

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India

Other Identifiers

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Erythropoietin 01

Identifier Type: -

Identifier Source: org_study_id

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