Condition category
Neonatal Diseases
Date applied
10/04/2018
Date assigned
16/04/2018
Last edited
19/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
When a baby is admitted to the neonatal unit, they will often be nursed in an incubator. Incubator care is normally used to provide a stable temperature environment to help the baby maintain his/her temperature at a normal level, until old enough, or big enough, to regulate their own temperature and can be transferred into an open cot. The aim of this study is to compare the level of thermal care delivered to a clinically stable baby in the mOm incubator and a standard (non-humidified) incubator.

Who can participate?
Babies who are stable and clinically well, but still require incubator care, without needing extra humidification, for at least the next 48 hours

What does the study involve?
The participating babies are randomly allocated to one of two groups. In one group the baby is in a standard incubator with close (hourly) monitoring of vital signs such as temperature, and in the second group the same observations are carried out but the baby is nursed in the mOm incubator. After 24 hours, the babies change over to the other incubator. There are no extra tests needed. At the end of the 48 hours the babies are returned to normal care. The staff are also asked to complete a questionnaire to give their opinion of the use of each type of incubator.

What are the possible benefits and risks of participating?
The participating babies will be more closely observed than in standard care. The mOm incubator has been carefully designed to maintain a stable temperature environment for the baby and has been manufactured under current Good Manufacturing Practice (GMP). The clinical research team have full control and responsibility for the baby’s care and can withdraw a subject from the study at any time for any reason. The risks should therefore be no more than for standard routine incubator care.

Where is the study run from?
Ashford and St Peter's Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
February 2018 to December 2018

Who is funding the study?
mOm Incubators Limited (UK)

Who is the main contact?
1. Dr Peter Reynolds (public)
2. Mrs Rosalyn Mazey (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Peter Reynolds

ORCID ID

Contact details

Ashford and St. Peter's Hospitals NHS Foundation Trust
Department of Paediatrics
St Peter's Hospital
Guildford Road
Chertsey
London
KT16 0RZ
United Kingdom

Type

Scientific

Additional contact

Mrs Rosalyn Mazey

ORCID ID

Contact details

mOm Incubators Limited
WeWork Paddington
2 Eastbourne Terrace
London
W2 6LG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03450668

Protocol/serial number

Protocol ref: mOm/2018/0, IRAS number: 224546

Study information

Scientific title

Comparison of the mOm incubator with a standard incubator for the maintenance of thermal stability in preterm infants with user feedback

Acronym

mOm01

Study hypothesis

The study will compare the level of thermal care delivered to a clinically stable baby in the mOm incubator and a standard (non-humidified) incubator.

Ethics approval

London and Surrey Borders Regional Ethics committee - submission pending

Study design

Multi-centre randomized controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Preterm natal hypothermia

Intervention

The study is split into two arms. One arm is where the baby is in a standard incubator, with close (hourly) monitoring of vital signs such as temperature, and the second arm is where the same observations are carried out, but this time the baby is being nursed in the mOm incubator. Pre-prepared blinded randomization codes will be used which will decide whether the first 24 hours are in the standard incubator or in the mOm incubator. After 24 hours, the baby changes over to the other incubator. There are no extra tests. At the end of the 48 hours the baby will be returned to normal care.

A target of 40 participants will be recruited to provide 36 complete sets of data since parents/legal guardians or research staff can withdraw the baby from the study at any time. Staff will also be asked to complete a questionnaire to give their opinion of the use of each type of incubator.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Thermo-regulation ability of incubator to maintain stable core temperature of the baby over 24 hours, measured on an hourly basis

Secondary outcome measures

1. Baseline data such as weight, gender, temperature, GA at birth, date of birth and current age of the baby will be recorded on entry to the study
2. Hourly observations (+/- 15 minutes) will be taken throughout the following 48 hours of incubator care, and will include temperature data of the incubator, plus routine clinical observations of the baby (i.e. pulse rate, temperature, O2 saturation and respiration), plus blood pressure recorded at least once per day
3. Usability: time to clean incubator between uses, recorded after incubator used for each subject
4. Adverse events: summarized at end of study and assessed on an ongoing basis if they arise
5. Staff feedback: all staff involved in the use of the incubator for care of the baby within, set up or cleaning will complete a questionnaire and provide any further anecdotal comments they wish to make

Overall trial start date

05/02/2018

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parent/legal guardian is willing and able to give informed consent for participation in the study
2. Parent/legal guardian is aged 16 years or above
3. Participant considered clinically stable from a cardiorespiratory point of view
4. Participant requires incubator care but do not require additional humidification
5. Participant requires incubator care for at least 48 hours.
6. Participant is at least 30 weeks gestational age.
7. Participant is less than 8kg in weight

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Parent/legal guardian with learning disabilities or mental illness and are considered unable to give informed consent
2. Parent/legal guardian is a prisoner and young offender
3. Parent/legal guardian is considered to have a particularly dependent relationship with the investigator(s)
4. Parent/legal guardian is deemed to belong to a vulnerable group

Recruitment start date

01/01/2019

Recruitment end date

01/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ashford and St Peter's Hospital NHS Foundation Trust
KT16 0RZ
United Kingdom

Sponsor information

Organisation

mOm Incubators limited

Sponsor details

WeWork Paddington
2 Eastbourne Terrace
London
W2 6GL
United Kingdom

Sponsor type

Industry

Website

www.momincubators.com

Funders

Funder type

Industry

Funder name

mOm Incubators Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol is not published as it contains confidential information for a pre-market device. Planned publication of the results in a high-impact peer-reviewed journal if possible and presented at an international conference the intent to publish date around one year after the overall trial end date.

IPD sharing statement
The data will be available from Rosalyn Mazey, or mOm Incubators Ltd, in the form of the clinical study executive summary and each individual subject can be sent a copy of their individual data collected as per the Data Protection Act. This will be available for 5 years after the end of the study.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/11/2018: The following changes were made: 1. The recruitment start date was changed from 31/05/2018 to 01/01/2019. 2. The recruitment end date was changed from 30/10/2018 to 01/07/2019. 3. The overall trial end date was changed from 31/12/2018 to 31/12/2019. 4. The intention to publish date was changed from 31/12/2019 to 31/12/2020.