Randomized Controlled Double-Blind-Study of Role of Recombinant Erythropoietin in the Prevention of Chronic Lung-Disease
| ISRCTN | ISRCTN90717641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90717641 |
| Protocol serial number | N/A |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof MI Levene
Scientific
Scientific
Centre for Reproduction, Growth and Development
University of Leeds School of Medicine
The General Infirmary at Leeds
Leeds
LS2 9NS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled double blind study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the role of recombinant human erythropoietin (R-HuEpo) in reducing iron infusion, which may exacerbate free radical damage, leading to chronic lung disease. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Neonatal diseases |
| Intervention | Infants were randomly allocated and received either R-HuEpo (480 U/kg/wk) or placebo (4% human serum albumin) by twice weekly subcutaneous injection. |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of days on respiratory support |
| Key secondary outcome measure(s) |
Number of blood transfusions required |
| Completion date | 06/12/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Key inclusion criteria | 1. Gestational age <32 weeks and/or birthweight <1500 g 2. Requirement for mechanical ventilation and/or supplemental oxygen at birth 3. No severe renal, hepatic or coagulation disorders or major congenital malformation 4. Still require mechanical ventilation/oxygen on day 7-14 after birth |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1993 |
| Date of final enrolment | 06/12/1995 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Centre for Reproduction, Growth and Development
Leeds
LS2 9NS
United Kingdom
LS2 9NS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/1997 | Yes | No |
