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Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

S

Sheri Kashmir Institute of Medical Sciences

Status and phase

Completed
Phase 3
Phase 2

Conditions

Perinatal Asphyxia

Treatments

Drug: Erythropoietin

Study type

Interventional

Funder types

Other

Identifiers

NCT02002039
Erythropoietin 01

Details and patient eligibility

About

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

Full description

will be a randomized trial

Enrollment

100 patients

Sex

All

Ages

Under 6 hours old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

erythropoietin, perinatal asphyxia,
Active Comparator group
Description:
Treatment group
Treatment:
Drug: Erythropoietin
Normal saline, perinatal asphyxia
Placebo Comparator group
Description:
Normal saline on alternate days for 5 doses starting from first 6 hours of life
Treatment:
Drug: Erythropoietin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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