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
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
-
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.