Contact information
Type
Scientific
Primary contact
Dr Sam Easaw
ORCID ID
Contact details
Paediatric Intensive Care Unit
Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2717119
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0220183296
Study information
Scientific title
Randomised Prospective Trial to compare the efficacy of bolus versus continuous nasogastric feeding in Paediatric Intensive Care
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Prospective non-blinded randomised study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Time to achieve full entheral feeds by volume.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
10/04/2006
Overall trial end date
15/03/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
10/04/2006
Recruitment end date
15/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Children's NHS Foundation Trust
Sheffield
S10 2TH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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
Funders
Funder type
Government
Funder name
Sheffield Children's NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
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