Randomised Prospective Trial to compare the efficacy of bolus versus continuous nasogastric feeding in Paediatric Intensive Care
| ISRCTN | ISRCTN03644118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03644118 |
| Protocol serial number | N0220183296 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | Sheffield Children's NHS Foundation Trust, NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 04/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sam Easaw
Scientific
Scientific
Paediatric Intensive Care Unit
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
| Phone | +44 (0)114 2717119 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-blinded randomised study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised Prospective Trial to compare the efficacy of bolus versus continuous nasogastric feeding in Paediatric Intensive Care |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Feeding in intensive care |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Time to achieve full entheral feeds by volume. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 10/04/2006 |
| Date of final enrolment | 15/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
