The effect of early enteral feeding in patients suffering severe head injury and requiring mechanical ventilation

ISRCTN ISRCTN63461816
DOI https://doi.org/10.1186/ISRCTN63461816
Secondary identifying numbers R/TAYLOR/293
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
26/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Taylor
Scientific

North Bristol NHS Trust
7 Balmoral Court
Mangotsfield
Bristol
BS16 9DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesPatients suffering severe head injury commonly receive inadequate nutritional support for >5 days. Recent evidence suggests this is associated with an increased mortality and poor long-term outcome. However, the studies done so far have used early parenteral feeding to improve outcome. Parenteral feeding is itself a relatively high risk and high cost procedure. We propose to test the efficacy of early jejunal enteral feeding versus standard gastric enteral feeding in a prospective randomised controlled trial in patients with severe head injury, requiring mechanical ventilation. Retrospective analysis would specifically control for disease severity (Glasgow Coma Scale and Acute Physiology And Chronic Health Evaluation [APACHE] II) as well as other demographic and clinical parameters measured during the study. The aim is to determine the degree of clinical and functional benefit accruing from early enteral feeding (if any) and to differentiate possible sub-populations that most benefit from such treatment. Lastly, from metabolic data we hope to be able to postulate mechanisms for the effect of nutritional support and thus guide future research.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBrain injury
Intervention1. Early jejunal enteral feeding
2. Standard gastric enteral feeding
Intervention typeOther
Primary outcome measureNeurological outcome (Glasgow Outcome Scale 4 or 5) was determined at 3 and 6 months post injury and the incidence of infective and total complications was determined for hospital admission.
Secondary outcome measuresNot provided at time of registration
Overall study start date20/06/1994
Completion date31/10/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants82 (added 26/01/10; see publication)
Key inclusion criteriaPatients with severe head injury requiring mechanical ventilation
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment20/06/1994
Date of final enrolment31/10/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

North Bristol NHS Trust
Bristol
BS16 9DA
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/1999 Yes No