Perinatal Asphyxia
Conditions
Keywords
Perinatal asphyxia, erythropoietin
Brief summary
Whether Erythropoietin improves the neurological outcomes of neonates with perinatal asphyxia.
Detailed description
will be a randomized trial
Interventions
DRUGErythropoietin
500 units /kg /day every other day for 5 doses
Sponsors
Sheri Kashmir Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or moderate or severe disability at 18-22 months of age | 18-22 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability | 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. |
| Bayley psychomotor development index | 18-22 months months | — |
| Hearing loss at 18-22 months | 18-22 months | — |
Countries
India
Outcome results
None listed