HypothermiaNCT03450668
mOm Incubator Pilot Study
A study testing mOm incubator and standard incubator in people with Hypothermia, run by mOm incubators at 1 site in United Kingdom.
Trial summary
The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Read more about this study
- Who is it for?
- Ages 1 minute to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- mOm incubator and standard incubator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Oct 2021to 4 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least 30 weeks gestational age and less than or equal to 6kg
- In need of at least 48 hours incubation in a stable temperature environment
- Must be clinically stable
- Parental/legal guardian written informed consent has been given
Who cannot join
- Does not require humidity regulation
- Parent/legal guardian must not be from a vulnerable group
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ashford and St. Peter's Hospital
Chertsey, Surrey, KT16 0PZ
About this study
Official title: Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback
The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks gestational age and require at least 48 hours incubator care. A standard or test incubator will be used for the first 24 hours chosen randomly, then the baby will be moved to the over arm for a further 24 hours.
Read the detailed description
Investigators will recruit babies who are in the Neonatal Unit at St. Peter's Hospital. Babies will be clinically stable from a cardio-respiratory point of view. They will also be requiring incubator care (so they will weigh less than approximately 1400g) but not requiring additional humidification. This effectively excludes babies born less than 30 weeks gestation who are routinely humidified for the first week (if 28-30 weeks gestation) or two weeks (if less than 28 weeks gestation). Some term babies may also be eligible for the study if they are being nursed in an incubator for clinical reasons.
Identification and recruitment of babies will be carried out by the attending Consultant Neonatologist and the research team.
For twins, consecutive enrolment will be possible if only one mOm incubator is available.
There will be two arms to the protocol. The first arm will consist of standard incubator care, where the care of the baby is unchanged, but non-invasive, more frequent (hourly) temperature and other physiological measures of stability than would normally be collected in routine care (nominally every three hours) will be collected. The second arm will be the baby receiving normal care in the mOm incubator, with another set of hourly detailed, non-invasive, observations. The planned care and monitoring of the baby will be otherwise unchanged. No additional blood tests or any other invasive testing or monitoring are required. The clinical team will have full control and responsibility for the baby's care and can terminate the study for the baby at any time for any reason.
In addition, investigators will collect the views of staff on the baby's comfort, visibility, care, usability and acceptability during each arm of the study.
For each arm of the study, the secondary outcome measures are:
(1) pulse rate (as a measure of clinical stability) (2) respiratory rate (as a measure of clinical stability) (3) apnea and bradycardia episodes recorded by nursing staff (clinical stability) (4) temperature (as a measure of clinical stability) (4) adverse events related to incubator performance (5) cleaning ease and time took (6) set up time (7) staff structured feedback
36 eligible babies will be recruited into the study at a single site, being identified by the clinical team. All 36 will experience a 24 hour period in each of the two incubators (mOm and standard) (48 hours in total), in a randomly allocated order. Babies will act as their own controls in this cross-over study design. If any babies fail to complete the 48-hour study procedures (e.g. due to data incomplete or baby withdrawn) further babies will be recruited to achieve 36 complete datasets.
- Conditions
- Hypothermia
- Being tested
- mOm incubator, standard incubator
- Keywords
- neonatal, incubator, thermal-regulation
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mOm incubatorDevice
24 hour usage of test incubator
standard incubatorDevice
standard incubator
| Study group | Role | What they receive |
|---|---|---|
| standard incubator | Active comparator | routinely used standard incubator already used in the neonatal unit Receives: Device: mOm incubator; Device: standard incubator |
| mOm incubator | Experimental | new test incubator Receives: Device: mOm incubator; Device: standard incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
thermo-regulation
ability of incubator to maintain stable temperature of baby
Measured: 24 hours
Secondary outcomes (1)
Usability
Time to prepare for use and clean incubator (in-use cleaning and deep clean between use)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start27 Oct 2021
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a randomized two-arm crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- mOm incubators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450668
- Sponsor's protocol ID
- mOm/2018/01
- Status last verified
- May 2024
- First submitted
- 23 Feb 2018
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback
- ClinicalTrials.gov ID
- NCT03450668
- Acronym / sponsor ID
- mOm/2018/01
- Conditions
- Hypothermia
- Keywords
- neonatal, incubator, thermal-regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- mOm incubatorsUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mOm Incubator is a collapsible infant incubator designed to provide a level of thermoregulation that meets the standards set for conventional incubators whilst being low cost and space-saving. Babies recruited will be clinically stable, at least 30 weeks gestational age and require at least 48 hours incubator care. A standard or test incubator will be used for the first 24 hours chosen randomly, then the baby will be moved to the over arm for a further 24 hours.
Detailed description
Investigators will recruit babies who are in the Neonatal Unit at St. Peter's Hospital. Babies will be clinically stable from a cardio-respiratory point of view. They will also be requiring incubator care (so they will weigh less than approximately 1400g) but not requiring additional humidification. This effectively excludes babies born less than 30 weeks gestation who are routinely humidified for the first week (if 28-30 weeks gestation) or two weeks (if less than 28 weeks gestation). Some term babies may also be eligible for the study if they are being nursed in an incubator for clinical reasons.
Identification and recruitment of babies will be carried out by the attending Consultant Neonatologist and the research team.
For twins, consecutive enrolment will be possible if only one mOm incubator is available.
There will be two arms to the protocol. The first arm will consist of standard incubator care, where the care of the baby is unchanged, but non-invasive, more frequent (hourly) temperature and other physiological measures of stability than would normally be collected in routine care (nominally every three hours) will be collected. The second arm will be the baby receiving normal care in the mOm incubator, with another set of hourly detailed, non-invasive, observations. The planned care and monitoring of the baby will be otherwise unchanged. No additional blood tests or any other invasive testing or monitoring are required. The clinical team will have full control and responsibility for the baby's care and can terminate the study for the baby at any time for any reason.
In addition, investigators will collect the views of staff on the baby's comfort, visibility, care, usability and acceptability during each arm of the study.
For each arm of the study, the secondary outcome measures are:
(1) pulse rate (as a measure of clinical stability) (2) respiratory rate (as a measure of clinical stability) (3) apnea and bradycardia episodes recorded by nursing staff (clinical stability) (4) temperature (as a measure of clinical stability) (4) adverse events related to incubator performance (5) cleaning ease and time took (6) set up time (7) staff structured feedback
36 eligible babies will be recruited into the study at a single site, being identified by the clinical team. All 36 will experience a 24 hour period in each of the two incubators (mOm and standard) (48 hours in total), in a randomly allocated order. Babies will act as their own controls in this cross-over study design. If any babies fail to complete the 48-hour study procedures (e.g. due to data incomplete or baby withdrawn) further babies will be recruited to achieve 36 complete datasets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- a randomized two-arm crossover study
| Arm | Type | Receives |
|---|---|---|
| standard incubator | Active comparator | Device: mOm incubator, Device: standard incubatorroutinely used standard incubator already used in the neonatal unit |
| mOm incubator | Experimental | Device: mOm incubator, Device: standard incubatornew test incubator |
Who may qualify
- Ages
- 1 minute to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At least 30 weeks gestational age and less than or equal to 6kg
- In need of at least 48 hours incubation in a stable temperature environment
- Must be clinically stable
- Parental/legal guardian written informed consent has been given
Key exclusion criteria (2 listed)
- Does not require humidity regulation
- Parent/legal guardian must not be from a vulnerable group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mOm incubator24 hour usage of test incubator | Device | mOm incubator, standard incubator |
| standard incubatorstandard incubator | Device | mOm incubator, standard incubator |
Primary outcome
thermo-regulation
Time frame: 24 hours
ability of incubator to maintain stable temperature of baby
1 secondary outcome
Usability
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mOm incubator and standard incubator in people with Hypothermia, run by mOm incubators at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thermo-regulation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.