ISRCTN ISRCTN72984863
DOI https://doi.org/10.1186/ISRCTN72984863
Protocol serial number RHC18070
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
Funder NHS Executive North West (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
03/12/2008
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

Dr Alan Weindling
Scientific

Liverpool Women's Hospital
Neonatal Unit
Crown Street
Liverpool
L8 7SS
United Kingdom

Phone +44 (0)151 702 4093

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesDoes a blood transfusion in preterm infants cause free radical release?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNeonatal diseases
InterventionGroup 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 typeOther
Primary outcome measure(s)

The primary outcome measure will be peak ODFR activity.

Key secondary outcome measure(s)

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

Completion date01/08/1999

Eligibility

Participant type(s)Patient
Age groupNeonate
SexNot Specified
Key inclusion criteriaPreterm infants
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/02/1998
Date of final enrolment01/08/1999

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Liverpool Women's Hospital
Liverpool
L8 7SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2002 Yes No