NCT02002039

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

November 27, 2013

Last Update Submit

October 12, 2016

Conditions

Perinatal Asphyxia

Keywords

Perinatal asphyxiaerythropoietin

Outcome Measures

Primary Outcomes (1)

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

    18-22 months

Secondary Outcomes (3)

  • Disability

    18-22 months

  • Bayley psychomotor development index

    18-22 months months

  • Hearing loss at 18-22 months

    18-22 months

Study Arms (2)

erythropoietin, perinatal asphyxia,

ACTIVE COMPARATOR

Treatment group

Drug: Erythropoietin

Normal saline, perinatal asphyxia

PLACEBO COMPARATOR

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

Drug: Erythropoietin

Interventions

ErythropoietinDRUG

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

Also known as: erhthropoietin beta
Normal saline, perinatal asphyxiaerythropoietin, perinatal asphyxia,

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Babies with severe perinatal asphyxia with moderate to severe HIE in the immediate neonatal period

You may not qualify if:

  • Babies with congenital malformations
  • Small for gestational age babies
  • Babies with chromosomal anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheri-Kashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, India

Location

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Feroz Shaheen, MD

    SKIMS

    STUDY CHAIR

  • Prof. WAjid Ali

    SKIMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 5, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)