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Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
will be a randomized trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erythropoietin, perinatal asphyxia, | Active Comparator | Treatment group |
|
| Normal saline, perinatal asphyxia | Placebo Comparator | Normal saline on alternate days for 5 doses starting from first 6 hours of life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin | Drug | 500 units /kg /day every other day for 5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death or moderate or severe disability at 18-22 months of age | 18-22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disability | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feroz Shaheen, MD | SKIMS | Study Chair |
| Prof. WAjid Ali | SKIMS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheri-Kashmir Institute of Medical Sciences | Srinagar | Jammu and Kashmir | India |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| 18-22 months |
| Bayley psychomotor development index | 18-22 months months |
| Hearing loss at 18-22 months | 18-22 months |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |