Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R/TAYLOR/293
Study information
Scientific title
Acronym
Study hypothesis
Patients 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Brain injury
Intervention
1. Early jejunal enteral feeding
2. Standard gastric enteral feeding
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Neurological 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 measures
Not provided at time of registration
Overall trial start date
20/06/1994
Overall trial end date
31/10/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with severe head injury requiring mechanical ventilation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
82 (added 26/01/10; see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
20/06/1994
Recruitment end date
31/10/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
North Bristol NHS Trust
Bristol
BS16 9DA
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 South 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
Basic results (scientific)
Publication list
1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10579275
Publication citations
-
Results
Taylor SJ, Fettes SB, Jewkes C, Nelson RJ, Prospective, randomized, controlled trial to determine the effect of early enhanced enteral nutrition on clinical outcome in mechanically ventilated patients suffering head injury., Crit. Care Med., 1999, 27, 11, 2525-2531.