Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomized controlled double blind study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Number of days on respiratory support
Secondary outcome measures
Number of blood transfusions required
Overall trial start date
01/06/1993
Overall trial end date
06/12/1995
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1993
Recruitment end date
06/12/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Reproduction, Growth and Development
Leeds
LS2 9NS
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1997 results in http://www.ncbi.nlm.nih.gov/pubmed/9175950
Publication citations
-
Results
Griffiths G, Lall R, Chatfield S, Short A, Mackay P, Williamson P, Brown J, Levene MI, Randomised controlled double blind study of role of recombinant erythropoietin in the prevention of chronic lung disease., Arch. Dis. Child. Fetal Neonatal Ed., 1997, 76, 3, F190-2.