Erythropoietin in the treatment of birth asphyxia birth asphyxia.
Phase 3
- Conditions
- Health Condition 1: null- neonates with perinatal asphyxia
- Registration Number
- CTRI/2017/02/007918
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 192
Inclusion Criteria
1.GA >35 wks and Birth weight > 1800 g
2.PHYSIOLOGICAL CRITERIA- Any 1 of the following
a. ABG (Umbilical Cord/1st postnatal hr) pH < 7.0 or Base deficit (ABE) > - 12
b. Apgar score < 5 at 5â??
c. Ventilation required for at least 10â??as part of resuscitation
d. History of not having cried at birth
3.NEUROLOGICAL CRITERIA- Seizures OR Evidence of moderate or severe encephalopathy (3 of 6 criteria in modified Sarnat)
Exclusion Criteria
1. Lack of consent 2. Major congenital malformations 3. Imminent death anticipated at the time of assessment for eligibility 4. PCV > 65% 5. Any thrombosis 6. Blood pressure > 97th Centile
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Death or severe neurodevelopmental impairment at 24 months (any of the following): <br/ ><br>(i)DASII overall score 70; <br/ ><br>(ii)Neurological examination score 40 <br/ ><br>(iii)GMFCS levels III,IV,V; <br/ ><br>(iv)Impaired sensory/communication outcomes: blindness, deafness, impaired communication using functional definitions, ongoing seizure disorder <br/ ><br> <br/ ><br>Timepoint: 24 months
- Secondary Outcome Measures
Name Time Method Short term): <br/ ><br> MRI abnormalities at 5±1 days of life. <br/ ><br>Standardized Neurological examination at 7 days <br/ ><br>Intermediate term (10-15 weeks): Presence of Fidgety Movements (FM) using the General Movement Assessment (GMA) and a normal classification by the Computer based Infants Movement Analysis (CIMA). <br/ ><br>Long term: mild neurodevelopmental impairment (DASII score 70-84; Neurological examination score 40-67; or GMFCS level II); and individual subscale scores and impairments as appropriate. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 5 days, 10-15days