Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes