Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/01/2010
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 Stephen Taylor

ORCID ID

Contact details

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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10579275

Publication citations

  1. 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.

Additional files

Editorial Notes