| Source of record | UK Trials |
| ISRCTN | ISRCTN03644118 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0220183296 |
| Public title | Randomised Prospective Trial to compare the efficacy of bolus versus continuous nasogastric feeding in Paediatric Intensive Care |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Feeding in intensive care |
| Study hypothesis | The aim of the study is to compare bolus vs continuous nasogastric feeding in paediatric intensive care in achieving full nutritional requirement in the shortest time. |
| Design/methodology | Prospective non-blinded randomised study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | As this study is to compare feeding tolerance in Paediatric Intensive Care, patients will be recruited from serial admissions to the PICU. This is a single centre study in a regional intensive care unit of a teaching hospital with 11 beds. All children aged 1 month to 16 years admitted during a period of 6 months. The study period may be shortened or lengthened depending on the sample size to justify enough power for statistical analysis, but it is anticipated that it will not exceed 12 months once started. |
| Participants - exclusion criteria | 1. Children who have known gastro-oesophageal reflux disease, recent gastro-intestinal surgery, fundoplication, gastrostomy, inflammatory bowel disease, nasojejunal feeding, prokinetic use (Erythromycin, Clarithromycin or Domperidone) and any preset contra-indication to enteral feeds
2. Any patient requiring constant carbohydrate or dextrose input, eg metabolic patients
3. Patients participating in an ongoing research trial |
| Patient information material |
|
| Anticipated start date | 10/04/2006 |
| Anticipated end date | 15/03/2007 |
| Status of trial | Completed |
| Target number of participants | 100 |
| Interventions | Informed written consent from the parent will be obtained by senior member of medical staff. All patients will be enrolled within 6 hours of admission to PIC. The duration of the study period will either be completion of 48 hours in either randomised arm or discharge from PIC if this occurs sooner. Patients will be randomised at enrolment. Randomisation envelopes will be held in the controlled drugs cabinet in the ICU.
Patients will be randomised to receive either Protocol A (bolus feeds) or Protocol B (continuous feeds). Protocol A and B will only commence after confirmation of nasogastric tube position as per Sheffield Children's Hospital guidelines (available on PIC). Patients' weight and total daily fluid requirement noted (calculated on former as per PIC guidelines). All ventilated patients in PICU are fluid restricted to 80% of their total daily fluid requirement. The full feed allowance hence is 80% maintenance minus fluid administered as medications. Throughout the study period the nasogastric tubes will aspirated every 3 hours and the gastric residual volume recorded. |
| Primary outcome measure(s) | Time to achieve full entheral feeds by volume. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Sheffield Children's NHS Foundation Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Sam Easaw |
| Contact details | Paediatric Intensive Care Unit
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
United Kingdom
S10 2TH |
| Contact telephone | +44 0114 2717119 |
| Contact fax | +44 |
| Contact email | sameasaw@hotmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN03644118 |
| Date last extracted from ISRCTN register | 17/04/2008 |
