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
Secondary identifying numbers N0220183296
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

Paediatric Intensive Care Unit
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Phone +44 (0)114 2717119
Email abc@email.com

Study information

Study designProspective non-blinded randomised study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised Prospective Trial to compare the efficacy of bolus versus continuous nasogastric feeding in Paediatric Intensive Care
Study objectivesThe 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) studiedNutritional, Metabolic, Endocrine: Feeding in intensive care
InterventionInformed 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 typeProcedure/Surgery
Primary outcome measureTime to achieve full entheral feeds by volume.
Secondary outcome measuresNot provided at time of registration
Overall study start date10/04/2006
Completion date15/03/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Month
Upper age limit16 Years
SexBoth
Target number of participants100
Key inclusion criteriaAs 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 criteria1. 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 enrolment10/04/2006
Date of final enrolment15/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sheffield Children's NHS Foundation Trust

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan