mOm Incubator Pilot Study
| ISRCTN | ISRCTN14899342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14899342 |
| IRAS number | 224546 |
| ClinicalTrials.gov number | NCT03450668 |
| Secondary identifying numbers | Protocol ref: mOm/2018/0, IRAS number: 224546 |
- Submission date
- 10/04/2018
- Registration date
- 16/04/2018
- Last edited
- 11/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English summary of protocol
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 August 2022
Who is funding the study?
mOm Incubators Limited (UK)
Who is the main contact?
1. Dr Peter Reynolds (public)
2. Mrs Rosalyn Archer (scientific)
Contact information
Public
Ashford and St. Peter's Hospitals NHS Foundation Trust
Department of Paediatrics
St Peter's Hospital
Guildford Road
Chertsey
London
KT16 0RZ
United Kingdom
| Phone | +44 (0)1932723128 |
|---|---|
| peter.reynolds1@nhs.net |
Scientific
Archer Clinical Ltd
2 Almond Tree Road
Sheffield
S26 5LB
United Kingdom
| Phone | +44 (0)7853633079 |
|---|---|
| rarcher@momincubators.com |
Study information
| Study design | Multi-centre randomized controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Comparison of the mOm incubator with a standard incubator for the maintenance of thermal stability in infants in infants (≤6 kg) |
| Study acronym | mOm01 |
| Study objectives | 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(s) | Approved 19/11/2018, London – Harrow Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; 0207 104 8057; nrescommittee.london-harrow@nhs.net), ref: 18/LO/1757 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| 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 study start date | 05/02/2018 |
| Completion date | 06/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 43 |
| Key inclusion criteria | Current inclusion criteria as of 29/11/2021: 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 weighs 6 kg or less _____ Previous 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 8 kg in weight |
| Key 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 or 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 |
| Date of first enrolment | 01/11/2021 |
| Date of final enrolment | 31/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
Industry
WeWork Paddington
2 Eastbourne Terrace
London
W2 6GL
United Kingdom
| Website | www.momincubators.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 23/07/2021 | 20/09/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other unpublished results | version 1.0 | 01/06/2023 | 11/09/2023 | No | No |
Additional files
Editorial Notes
11/09/2023: An unpublished results file was added.
22/09/2022: Total final enrolment added.
15/09/2022: The following changes were made to the trial record:
1. The scientific title was changed from 'Comparison of the mOm incubator with a standard incubator for the maintenance of thermal stability in preterm infants with user feedback' to 'Comparison of the mOm incubator with a standard incubator for the maintenance of thermal
stability in infants in infants (≤6 kg)'.
2. The overall trial end date was changed from 01/10/2022 to 06/08/2022.
26/04/2022: The recruitment end date was changed from 01/04/2022 to 31/07/2022.
29/12/2021: The participant inclusion criteria have been changed.
20/09/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/09/2021 to 01/11/2021.
2. The protocol (not peer-reviewed) has been uploaded as an additional file.
01/07/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/06/2021 to 01/09/2021.
2. The recruitment end date has been changed from 01/01/2022 to 01/04/2022.
3. The overall trial end date has been changed from 01/07/2022 to 01/10/2022 and the plain English summary has been updated to reflect this change.
4. The intention to publish date has been changed from 01/07/2023 to 01/10/2023.
5. The trial contact has been updated.
09/07/2020: The trial contact details have been made publicly visible.
24/06/2020: Contact details updated.
06/05/2020: The following changes have been made:
1. The scientific contact has been updated.
2. The recruitment start date was changed from 01/06/2020 to 01/06/2021.
3. The recruitment end date was changed from 01/01/2021 to 01/01/2022.
4. The overall end date was changed from 01/07/2021 to 01/07/2022.
5. The intention to publish date was changed from 01/07/2022 to 01/07/2023.
6. The plain English summary has been updated accordingly.
23/07/2019: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 01/01/2019 to 01/06/2020.
3. The recruitment end date was changed from 01/07/2019 to 01/01/2021.
4. The overall end date was changed from 31/12/2019 to 01/07/2021.
5. The intention to publish date was changed from 31/12/2020 to 01/07/2022.
6. The plain English summary was updated to reflect these changes.
04/02/2019: The trial is on hold until 2020 due to manufacturing issues that mean the investigators will miss the deadline for MDD submission and need to gain their CE mark via the MDR. The investigators expect the trial to be delayed about one year when full manufacturing validation and CE marking will be achieved.
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.
