Condition category
Neonatal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
03/12/2008
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

Dr Alan Weindling

ORCID ID

Contact details

Liverpool Women's Hospital
Neonatal Unit
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4093

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC18070

Study information

Scientific title

Acronym

Study hypothesis

Does a blood transfusion in preterm infants cause free radical release?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

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

Group 1 will have their need for blood transfusion monitored according to a standard protocol.
Group 2 will have measurements of forearm fractional oxygen extraction (FOE) to guide their need for transfusions.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure will be peak ODFR activity.

Secondary outcome measures

A secondary outcome will be the number of days on the neonatal unit, retinopathy or prematurity, preventricular haemorrhage and periventricular leukomalacia and necrotising enterocolitis.

Overall trial start date

01/02/1998

Overall trial end date

01/08/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Preterm infants

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

01/02/1998

Recruitment end date

01/08/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
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 North West (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

2002 results on http://www.ncbi.nlm.nih.gov/pubmed/11815543

Publication citations

  1. Results

    Wardle SP, Garr R, Yoxall CW, Weindling AM, A pilot randomised controlled trial of peripheral fractional oxygen extraction to guide blood transfusions in preterm infants., Arch. Dis. Child. Fetal Neonatal Ed., 2002, 86, 1, F22-7.

Additional files

Editorial Notes