Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03450668 |
| Other study ID # |
mOm/2018/01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 27, 2021 |
| Est. completion date |
August 4, 2022 |
Study information
| Verified date |
December 2021 |
| Source |
mOm incubators |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
