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
Scientific
North Bristol NHS Trust
7 Balmoral Court
Mangotsfield
Bristol
BS16 9DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Brain injury |
| Intervention | 1. Early jejunal enteral feeding 2. Standard gastric enteral feeding |
| Intervention type | Other |
| 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 study start date | 20/06/1994 |
| Completion date | 31/10/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 82 (added 26/01/10; see publication) |
| Key inclusion criteria | Patients with severe head injury requiring mechanical ventilation |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 20/06/1994 |
| Date of final enrolment | 31/10/1997 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
North Bristol NHS Trust
Bristol
BS16 9DA
United Kingdom
BS16 9DA
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
