Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof MI Levene

ORCID ID

Contact details

Centre for Reproduction
Growth and Development
University of Leeds School of Medicine
The General Infirmary at Leeds
Leeds
LS2 9NS
United Kingdom

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes