Condition category
Neonatal Diseases
Date applied
12/03/2015
Date assigned
18/03/2015
Last edited
09/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Currently when looking after babies in intensive care, doctors do not have an ability to weigh them accurately if they are ventilated. This means that sick babies have to be disconnected from the artificial breathing machine (ventilator) in order to weigh them. They are then weighed on standalone electronic scales, without the ventilator attached. Since most sick babies do not tolerate this procedure, they are not weighed and this means that medicines, fluids and electrolytes are calculated by estimation (guessing) their weight, which potentially can lead to over or under dosing.
This study aims to determine whether we could safely and accurately weigh ventilated babies within the incubator on integral incubator scales, whilst still connected to the ventilator, by comparing their weight with and without a ventilator tube compensator device against their true (electronic standalone scale) weight.

Who can participate?
Any ventilated stable baby

What does the study involve?
We weighed ventilated babies within the incubator on integral incubator scales, whilst still connected to the ventilator, and compared their weight with and without a ventilator tube compensator device against their true (electronic standalone scale) weight, whilst disconnected from the ventilator.

What are the possible benefits and risks of participating?
No direct benefit for infant and no anticipated risks, since only carried out in stable ventilated babies.

Where is the study run from?
Salford Royal Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2009 to August 2011

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Ula El-Kafrawy

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ula El-Kafrawy

ORCID ID

Contact details

Royal Bolton Hospital
Bolton
Manchester
Manchester
BL4 0JR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Optimising the care of ventilated infants by weighing accurately on incubator scales

Acronym

Study hypothesis

Assessing the accuracy of integral incubator scales in weighing ventilated infants

Ethics approval

Cambridgeshire 2 Ethics Committee, 09/04/2008, REC ref: 08/H0308/35

Study design

Diagnostic accuracy study

Primary study design

Observational

Secondary study design

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Assessing the accuracy of integral incubator scales in weighing ventilated infants

Intervention

Comparison of weights of ventilated infants when weighed on incubator scales against true weight

Intervention type

Phase

Drug names

Primary outcome measures

The weight of the ventilated baby was compared by 2 different methods, one by weighing on incubator scales whilst ventilated and one by weighing on freestanding electronic scales whilst not ventilated, the weights were done at baseline within a few minutes of each other. They were then compared by the statistical method of Bland and Altman.

Secondary outcome measures

Inaccuracy correctable by use of a ventilator tube compensator device

Overall trial start date

01/02/2009

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Any ventilated baby

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

30

Participant exclusion criteria

No exclusion criteria.

Recruitment start date

01/06/2009

Recruitment end date

01/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Salford Hospital
Salford
Manchester
United Kingdom

Sponsor information

Organisation

Royal Salford NHS Trust

Sponsor details

Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Salford NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To publish a medical paper for a paediatric/neonatal journal and currently submitting for publication to the Archives of disease in Children, Fetal & Neonatal edition.

Intention to publish date

31/12/2015

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes