| Trial name or title | Erythropoietin in premature infants to prevent encephalopathy: a multi‐centre randomised blinded controlled study of the efficacy of erythropoietin in China |
| Methods | Multi‐centre randomised blinded controlled study |
| Participants | Preterm infants |
| Interventions | Experimental: Erythropoietin EPO is administered 1000 U/kg IV in 48 hours after preterm birth, and at 48‐hour intervals for 3 doses per week. After 6 doses, subcutaneously 3 doses per week until at corrected age of 34 weeks. Placebo comparator: Normal saline is administered 5 mL IV at 3 to 6 hours after preterm birth, and at 48‐hour intervals for 3 doses per week. After 6 doses, subcutaneously 3 doses per week until at corrected age of 34 weeks |
| Outcomes | Primary outcome measures: neurodevelopment (Bayley Scores) [Time Frame: At corrected age of 18 months]. To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSID) and incidence of MDI < 70 (severe) or MDI < 85 (moderate). Neurological evaluation (GMFM‐88 scores) [Time Frame: At corrected age of 18 months]. To gain changes in standardised gross motor function using GMFM (Gross Motor Function Measure) as a standardised measurement tool for assessing gross motor function consisting of sub scales, lying and rolling, sitting, crawling and kneeling, standing, walking, running and jumping (range: 0 to 100, higher value means better gross motor function). Secondary outcome measures: numerous |
| Starting date | September 2015 |
| Contact information | Wenhao Zhou, Doctor (+86)021‐64931003; zwhchfu@126.com |
| Notes | NCT02550054 |
BSID: Bayley Scales of Infant Development. EPO: erythropoietin. GMFM: Gross Motor Function Measure. MDI: Mental Development Index. PDI: Psychomotor Development Index. PMA: postmenstrual age.