Improving the care of ventilated preterm babies by weighing them within the incubator
| ISRCTN | ISRCTN58085619 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58085619 |
| Protocol serial number | N/A |
| Sponsor | Royal Salford NHS Trust |
| Funder | Royal Salford NHS Trust |
- Submission date
- 12/03/2015
- Registration date
- 18/03/2015
- Last edited
- 04/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Royal Bolton Hospital
Bolton
Manchester
Manchester
BL4 0JR
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Diagnostic accuracy study |
| Secondary study design | |
| Scientific title | Optimising the care of ventilated infants by weighing accurately on incubator scales |
| Study objectives | Assessing the accuracy of integral incubator scales in weighing ventilated infants |
| Ethics approval(s) | Cambridgeshire 2 Ethics Committee, 09/04/2008, REC ref: 08/H0308/35 |
| Health condition(s) or problem(s) studied | 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 | |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Inaccuracy correctable by use of a ventilator tube compensator device |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Any ventilated baby |
| Key exclusion criteria | No exclusion criteria. |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 01/02/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Manchester
M6 8HD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2016 | Yes | No |
Editorial Notes
04/07/2017: Publication reference added.
