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Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

Information source: Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Perinatal Asphyxia

Intervention: Erythropoietin (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Sheri Kashmir Institute of Medical Sciences

Official(s) and/or principal investigator(s):
Feroz Shaheen, MD, Study Chair, Affiliation: SKIMS
Prof. WAjid Ali, Study Director, Affiliation: SKIMS

Overall contact:
Dr. Mushtaq Bhat, MD, Email: mbhat47@rediffmail.com

Summary

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

Clinical Details

Official title: Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

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

Primary outcome: Neurodevelopmental outcome at 6 months of age

Secondary outcome:

Death and or disability at 12-18 months of age

Hearing Impairment at 12-18 months of age

Eligibility

Minimum age: N/A. Maximum age: 6 Hours. Gender(s): Both.

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

Locations and Contacts

Dr. Mushtaq Bhat, MD, Email: mbhat47@rediffmail.com

Sheri-Kashmir Institute of Medical Sciences, Srinagar, Jammu and kashmir, India; Recruiting
Mushtaq Bhat, MD, Email: mbhat47@rediffmail.com
Additional Information

Starting date: November 2012
Last updated: December 11, 2014

Page last updated: August 20, 2015

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