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Completed

NCT Number: NCT02002039

Neuroprotective Role of Erythropoietin in Perinatal Asphyxia

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

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Key information

Conditions

Perinatal Asphyxia

Age range

Up to 6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sheri-Kashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, India

About this study

will be a randomized trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin

Drug

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

Other names: erhthropoietin beta

Primary outcomes

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

    Time frame: 18-22 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheri Kashmir Institute of Medical Sciences

Other

Registry information

Official study title

Erythropoietin in Perinatal Asphyxia: A Randomized Placebo Controlled Trial

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2013
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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