Comparison of the mOm Incubator With a Standard Incubator for the Maintenance of Thermal Stability in Preterm Infants With User Feedback
Phase: NA
Conditions: Hypothermia
Sponsor: mOm incubators

 
 
This document is the confidential property of mOm Incubators Limited and should not be copied or 
disseminated outside the Clinical Research Team and appropriate hospital and regulatory bodies. 
 
 
 
 
 
 
CLINICAL INVESTIGATION PLAN 
 
 
 
 
Comparison of the mOm incubator with a 
standard incubator for the maintenance of 
thermal stability in infants (6kg)  
 
 
 
Short Title: mOm Incubator Pilot Study 
 
 
Sponsor CIP ref: mOm/2018/01 
Version: 3.0, dated 09 March 2022 
 
IRAS number: 224546 
 
Clinicaltrials.gov: NCT03450668 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This Clinical Investigation Plan (CIP) has regard for the Health Research 
Authority (HRA) guidance and order of content 
 

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SIGNATURE PAGE 
The undersigned confirm that the following CIP has been agreed and accepted and 
that the Chief Investigator agrees to conduct the study in compliance with the 
approved CIP and will adhere to the principles outlined in the Declaration of Helsinki, 
relevant Sponsor’s Standard Operating Procedures (SOP)s and study specific 
procedures, the principles of Good Clinical Practice (GCP) and any other relevant 
regulatory requirements. 
I agree to ensure that the confidential information contained in this document will not 
be used for any other purpose other than the evaluation or conduct of the investigation 
without the prior written consent of the Sponsor. 
I also confirm that I will make the findings of the study publicly available through 
publication or other dissemination tools without any unnecessary delay and that an 
honest accurate and transparent account of the study will be given.  Any discrepancies 
from the study as planned in this protocol will be explained. 
For and on behalf of the Study Sponsor: 
Signature:  
.............................................................................................. 
Date: 
....../....../...... 
Name: Rosalyn Archer 
Position: Director of Clinical Affairs, mOm Incubators Ltd 
Chief Investigator: 
Signature: 
.............................................................................................. 
Date: 
....../....../...... 
Name: Dr Peter Reynolds 
Position: Neonatal Consultant, Ashford and St Peter’s 
Hospitals NHS Foundation Trust  
15
03 2022

 
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i. 
LIST OF CONTENTS 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
1 
SIGNATURE PAGE 
2 
i. LIST OF CONTENTS 
 
3 
ii. KEY STUDY CONTACTS 
5 
iii. CLINICAL INVESTIGATION PLAN AMENDMENT HISTORY 
5 
iv. STUDY SUMMARY 
6 
v. ROLE OF SPONSOR AND INVESTIGATOR 
6 
vi. LIST OF ABBREVIATIONS 
7 
vii. STUDY FLOW CHART 
8 
SECTION  
1. BACKGROUND  
9 
1.1 
Standard Practice 
9 
1.2 
mOm Incubator 
9 
2. RATIONALE 
 
9 
2.1      Assessment of benefits / risks and management of risk 
10 
2.2.1 Benefits 
10 
2.2.2 Risks and Management of Risk 
10 
3. OBJECTIVES 
10 
3.1 
Primary objective 
10 
3.2 
Secondary objectives 
11 
4. OUTCOME MEASURES 
11 
4.1 
Primary Outcome Measure 
11 
4.2 
Secondary Outcome Measures  
11 
4.2.1 Clinical stability 
11 
4.2.2 Temperature stability and regulation 
11 
4.2.3 Usability 
11 
4.2.4 Adverse events 
11 
4.2.5 Staff feedback 
11 
5. STUDY DESIGN 
11 
6. STUDY PROCEDURES 
12 
6.1 
Recruitment 
12 
6.2 
Procedure 
13 

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6.3 
Inclusion / Exclusion Criteria 
14 
6.3.1  Inclusion criteria 
14 
6.3.2  Exclusion criteria 
14 
6.4 
Withdrawal of Patients from the study 
14 
7. ADVERSE EVENTS
15 
7.1 
Adverse event (AE) 
15 
7.2 
Anticipated Adverse Event 
15 
7.3 
Serious Adverse Events 
15 
7.4 
Reporting of Adverse Events 
15 
8. STATISTICS AND DATA ANALYSIS
19 
9. ETHICS
20 
9.1 
Declaration of Helsinki 
20 
9.2 
Independent Ethics Committee Approval 
20 
9.3 
Informed Consent 
20 
10. SUBJECT CONFIDENTIALITY
20 
11. DATA MANAGEMENT
20 
11.1   Data Quality Assurance 
21 
11.2   Data Storage at the end of the study 
21 
12. FINANCING AND INSURANCE/INDEMNITY
22 
13. CLINICAL SUPPLIES
22 
14. REPORTING AND DISSEMINATION OF STUDY OUTCOMES
22 
15. REFERENCES
22 
16. INVESTIGATOR APPROVAL STATEMENT
24 

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ii.
KEY STUDY CONTACTS
Chief Investigator (CI) and 
Medical Expert 
Dr Peter Reynolds, Neonatology Consultant, 
Ashford and St Peter’s Hospitals NHS Foundation 
Trust, St Peter’s Hospital, Guildford Rd, Lyne, 
Chertsey KT16 0PZ 
peter.reynolds1@.nhs.net 
01932 723499 
Study Co-ordinator (Project 
manager) 
Rosalyn Archer, Director of Clinical Affairs, 
mOm Incubators Limited 
rarcher@momincubators.com 
07853 633079 
Sponsor 
mOm Incubators Limited, 
Newstead House, 
Pelham Road, 
Nottingham, 
NG5 1AP  
www.momincubators.com 
Funder 
Sponsor funded: mOm Incubators Limited 
Key Protocol Contributors 
Dr Peter Reynolds and mOm Incubators Limited 
iii.
CLINICAL INVESTIGATION PLAN AMENDMENT HISTORY
Amendment 
No. 
CIP Version 
No. 
Date issued 
Author(s) of 
changes 
Details of Changes made 
N/a 
1.0 
10 April 2018 
Dr Peter 
Reynolds, Dr 
Isabel Reading 
(statistician) and 
Rosalyn Mazey 
Original Clinical Investigation 
Plan  
1 
2.0 
23 July 2021 
Mariska Gulati 
Title Updated 
Dates and staff role/details 
updated. Adverse event 
causality updated to 
MDR/MDCG guidance 
requirements. 
2 
3.0 
Updated to clarify when 
recordings are required for 
each 
Mariska Gulati 
09 March 2022

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clinical data parameter and 
updated target recruitment 
period. 
iv.
STUDY SUMMARY
Study Title 
Comparison of the mOm incubator with a standard incubator 
for the maintenance of thermal stability in infants (6kg) 
Internal ref. 
mOm/2018/01 
Study Design 
Prospective, multi-centred, randomised, controlled, cross-
over study 
Study Subjects 
Babies at least 30 weeks Gestational age (GA) that are 
clinically stable but require at least 48 hours 
thermoregulated incubator care 
Planned Size of Sample (if 
applicable) 
36 completed subjects 
Planned participation duration 
48 hours per subject 
Planned Study Period 
Until recruitment is complete (target of nine months 
maximum recruitment period) 
Research Question/Aim(s) 
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. Staff feedback on the 
experience of using the mOm incubator will also be 
collected.  
v.
ROLE OF SPONSOR AND INVESTIGATOR
Dr Peter Reynolds is the CI for this study and will be involved in all aspects of the study 
oversight.  Both the CI and Principal Investigator (PI) at any other site(s) involved in 
the study are responsible for conduct of the study at their site and delegation of 
authority to appropriately qualified, and GCP trained, staff. This includes Sub/Co-
investigators (SIs) (other consultants), research nurses (RNs) and any other members 
of the clinical research team.  The CI and PI must complete a ‘Delegation of Authority 
Log’ detailing who may perform which study tasks including: gaining written informed 
consent from subjects’ parents/legal guardians, recruitment, conduct of study data 
collection, completion / maintenance of study records and site files, and the final sign-
off of each subject Case Report Form (CRF). 
The investigators and Sponsor project manager are responsible for providing 
appropriate training for staff involved in the study and writing up the results of the study 
and management of their publication and appropriate dissemination. 
The Sponsor is funding the study, providing the mOm incubators, study management 
and data collection documentation and will be responsible for conducting source data 
verification (SDV) and checking site adherence to the CIP. 
Dr Isabel Reading from the Faculty of Medicine at Southampton University, has 
provided statistical advice for this study. 

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vi.
LIST OF ABBREVIATIONS
ADE 
Adverse Device Event 
AE 
Adverse Event 
CI 
Chief Investigator 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
GA 
Gestational Age 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulations 
GMP 
Good Manufacturing Practice 
HRA 
Health Research Authority 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ISF 
Investigator Site File 
ISRCTN 
International Standard Randomised Controlled Trials Number 
MHRA 
Medicines and Healthcare products Regulatory Agency 
NHS R&D 
National Health Service Research & Development 
PI 
Principal Investigator 
PIS 
Subject Information Sheet 
REC 
Research Ethics Committee 
RN 
Research Nurse 
SADE 
Serious Adverse Device Event 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
SI 
Sub-Investigator (consultants working on the study with 
delegated responsibility from the PI/CI) 
SOP 
Standard Operating Procedure 
TMF 
Trial Master File 

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vii.
STUDY FLOW CHART
Subject identification (screening)
Parental / legal guardian study discussion 
Written Consent given 
Consent NOT given 
Continue with 
standard care 
Recruit to study 
Assign subject number and open envelope to 
reveal randomisation code 
Record baseline data in source documents and case report form (CRF) 
Incubator type (Arm 1) 
mOm              standard 
24-hrs
24-hrs
Incubator type (Arm 2) 
standard            mOm  
24-hrs
24-hrs
Record hourly observations for 24-hrs; note any Adverse Events 
Move subject to second incubator type 
Record hourly observations for 24-hrs; note any Adverse Events 
Return subject to standard care  
Complete staff usability questionnaire

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1.
BACKGROUND
Prematurely born infants are nursed in incubators to provide a stable and warm 
environment, until they can maintain a stable temperature in an open / warmed cot.  It 
has been known for decades that hypothermia in the premature infant can cause cold 
stress resulting in poor weight gain and metabolic stress1,2.  The baby maintains its 
normal temperature via hypothalamic control mechanisms, creating warmth 
(thermogenesis) through shivering and non-shivering mechanisms3.  In the preterm or 
growth restricted baby, these mechanisms are less well developed, placing them at 
additional risk. In the developing world, hypothermia is associated with significant 
mortality especially in these higher risk patients4. 
1.1 
Standard Practice 
In the developed world, premature and growth restricted babies generally have access 
to sophisticated conventional incubators in hospital, which provide uniform and 
controlled temperature to minimise thermal stress.  Generally, all babies born less than 
1500g would normally be cared for in an incubator until they are able to regulate their 
temperature outside of a controlled environment; this cut-off varies between hospitals 
(e.g. 1400g at St Peter’s hospital, London, but 1500g at St Mary’s hospital, 
Manchester).  
1.2 
mOm Incubator 
The mOm Incubator (trade name mOm Essential Incubator) is a infant incubator 
designed to provide a level of thermoregulation that meets the standards set for 
conventional incubators whilst being low cost and space-saving.  James Roberts (CEO 
of mOm Incubators Limited) invented the mOm incubator after watching a 
documentary on Syria where he learned that, because of the stress of war, infant 
mortality rates have soared causing the country to lose nearly an entire generation to 
preventable infant deaths.  The incubator design was part of his Design Engineering 
course at Loughborough University; he went on to win the Sir James Dyson Global 
Prize for Innovation in 2014. 
2.
RATIONALE
The mOm incubator fulfils the need to provide incubator care for babies requiring 
thermoregulation where standard incubators may not be available, such as in low to 
medium income countries. 
This study aims to compare the ability of the mOm incubator to provide an adequate 
thermoregulated environment when used in a clinical setting using a prospective, 
multi-centre, randomised, cross-over study design to provide a direct comparison with 
standard incubators.  It is hoped that the results of this study and the introduction of 
the mOm incubator could help to improve the survival rates of preterm babies born in 
places where access to expensive standard incubators is limited or not available. 
The hypothesis is that the mOm incubator will perform as well as a standard incubator 
for routinely maintaining temperature stability in the baby. 

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2.1 
Assessment of benefits / risks and management of risk 
2.2.1 Benefits 
The only direct benefit for subjects in this study is that the participating babies will be 
more closely observed than in standard care for babies fitting the inclusion criteria.  
2.1.2 Risks and Management of Risk 
The mOm incubator has been carefully designed to maintain a stable temperature 
environment for the baby.  
The mOm infant incubator been manufactured under current Good Manufacturing 
Practice (GMP), designed and tested to provide a level of thermoregulation that meets 
the harmonised standards set for conventional baby incubators (BS EN 60601-2-
19)5,6.  More information and testing results for the mOm incubator will be provided to
the site clinical research team in the form of an Investigator Brochure (IB).  The clinical
research team will 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.
If for any reason the subject, or incubator, has any unforeseen serious adverse event 
whilst the baby is in the mOm incubator the subject will immediately be removed from 
the study and placed into standard care.  Monitoring of the serious adverse event will 
be followed up and if the adverse event is a serious device adverse event, the study 
will be halted with immediate effect and only be continued when the Sponsor and Chief 
Investigator are confident that the issue is resolved and will not be repeated. 
If there are any concerns about temperature stability (or any other matter) in any baby 
being nursed in the mOm incubator during the study, then standard protocols for 
clinical evaluation by a doctor will be followed.  At the discretion of the attending 
clinician, the baby can be moved into a conventional (standard) incubator at any time 
without restriction.  A spare standard incubator will always be available for this 
purpose. 
If there are unexpected clinical incidents such as Serious Adverse Device Events 
(SADE) these will be reported to the Sponsor, the Research Ethics Committee 
(REC), Medicines and Healthcare products Regulatory Agency (MHRA), NHS Trust 
Research and Development as well as through the normal NHS Trust Risk reporting 
mechanisms (Datix). 
Photographs and/or video recordings of the use of the mOm incubator may be taken 
during the study but will be taken in such a way so that the baby cannot be identified. 
The study will adhere to the principles outlined in the Declaration of Helsinki7, relevant 
Sponsor’s SOPs and study- specific manuals included in the Investigator Site File 
(ISF) and Trial Master File (TMF), and, will follow the principles of GCP8. 
3.
OBJECTIVES
3.1 
Primary objective
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. 

 
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3.2 
Secondary objectives 
Assessment of: 
• Comparability to maintain clinical stability by measurement of physiological 
parameters. 
• The mOm incubators ability to maintain and regulate its temperature to within 
the appropriate BS standard5 in clinical practice. 
• Comparison of between subject cleaning times. 
• Incubator performance related adverse events. 
• Staff feedback on the experience of using the mOm incubator (i.e. usability) will 
also be collected.  
 
 
4. 
OUTCOME MEASURES 
4.1 
Primary Outcome Measure 
Thermo-regulation ability of incubator to maintain stable core skin temperature of the 
baby over 24 hours.  
 
4.2 
Secondary Outcome Measures  
4.2.1 Clinical stability: 
• Pulse rate (Hourly) 
• Respiratory rate (Hourly) 
• Oxygen saturation (Hourly) 
• Blood pressure (As per standard of care or at least once per day) 
• Axiliary Temperature (As per standard of care, usually every 2-4 hours) 
 
4.2.2 Temperature stability and regulation 
Hourly record of temperatures displayed on the incubator: 
• the actual incubator temperature 
•  set temperature of the incubator 
• Core/truncal temperature (from vital signs monitor/skin probe)  
 
4.2.3 Usability 
Time to clean each incubator type between/after use. 
 
4.2.4 Adverse events 
ADE and SADEs assessed. 
 
4.2.5 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. 
 
 
5. 
STUDY DESIGN 
The study has a prospective, multi-centre, randomised controlled, cross-over design.  
There will be two arms to the research.  The first arm will consist of mOm incubator 

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care for 24 hours, followed by a further 24 hours where the subject is transferred for 
care to a standard incubator. The second arm will consist of 24 hours care in a 
standard incubator followed by 24 hours care in a mOm incubator. The care of the 
baby (subject) is mostly unchanged from standard incubator care, but observations 
may be recorded more frequently (i.e. hourly) for incubator displayed temperatures 
and some other physiological measures of clinical stability than would normally be 
collected in routine care for this type of clinically stable baby of at least 30 weeks GA 
(normally every three hours) (See Table 1).  No additional blood tests or any other 
invasive testing or monitoring are required.  The clinical research team will have full 
control and responsibility for the baby’s care, with the ability to withdraw the baby from 
the study at any time for any reason if they feel the baby is clinically unstable or is 
adversely affected by their environment.  The order of incubator type in which the baby 
is cared for (i.e. which arm of the study) before being crossed over to the alternative 
incubator type will be assigned at random at the point of written consent being gained 
and the subject therefore having been officially recruited.  
Babies that are considered clinically stable from a cardio-respiratory point of view but 
require at least 48 hours incubator care but not requiring additional humidification will 
be recruited to the study from the Neonatal Unit.  In practice, this will mostly be babies 
weighing less than approximately 1400g at 30 weeks, although some term babies may 
also be eligible for the study if they are being nursed in an incubator for clinical 
reasons.   
The aim is to collect 36 completed data sets for analysis; to achieve this approximately 
40 babies will be recruited; recruitment will be stopped once 36 completed data sets 
are available.  The target is to complete recruitment within a nine-month period. 
6.
STUDY PROCEDURES
6.1 
Recruitment
Identification and recruitment of subjects will be carried out by the attending Consultant 
Neonatologist and the clinical research team to whom responsibility has been 
delegated via the delegation of authority log.   
Babies who are already being cared for in the Neonatal Unit, that meet the inclusion 
criteria for the study are eligible to be recruited as study subjects.  For twins, 
consecutive enrolment will be possible if an appropriate incubator is available. 
The parents/legal guardians of the baby(s) will be approached by a suitably qualified 
member of the clinical research team to provide written informed consent for their 
baby(s) to be recruited to this study.  They will be given a Participant Information Sheet 
(PIS) to read and given the opportunity to discuss the study and ask any questions.  It 
will be explained to them that allowing their baby to become a subject in the study is 
totally voluntary and if they do not agree to giving their consent, the standard care 
given will not be affected.  If they do agree to let their baby become a subject in the 
study, they will be asked to sign an Informed Consent Form (ICF) of which they will be 
given a copy.  Once written informed consent has been gained, the subject is 
registered on the enrolment log, considered recruited to the study and assigned a 
subject number. 

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6.2 
Procedure 
There will be two arms to the protocol as detailed in section 5.  The Case Report Form 
labelled with the appropriate subject number contains the data forms for that subject 
and a randomisation envelope attached inside the cover of the CRF which indicates 
which incubator type (standard or mOm) will be used for the baby to spend the first 24 
hours in, before being switched to the alternate incubator type for a further 24 hours.  
All data collected for the duration of the study will be entered in the appropriate source 
data (e.g. medical notes, electronic data capture systems, cleaning logs etc) and into 
the subject’s CRF. Adverse events (AE) should be entered. 
Baseline data such as length, weight, gender, core/truncal temperature (recorded at 
time point 0 in physiological recordings section), GA at birth, date of birth and current 
age of the baby will be recorded on entry to the study.  Hourly observations (+/- 15 
minutes) will be taken throughout the following 48 hours of incubator care, and will 
include temperature data displayed on the incubator, plus routine clinical observations 
of the baby (i.e. pulse rate, O2 saturation and respiration rate), plus axillary 
temperature as per standard practice and blood pressure recorded at least once per 
day (See Table 1 below) 
Table 1: Clinical Data Recording 
Parameter 
Frequency 
Core/Truncal Temperature 
Hourly 
Pulse Rate 
Hourly 
Oxygen Saturation 
Hourly 
Respiration Rate 
Hourly 
Axillary Temperature 
As per standard of care (usually every 2-4hrs) 
Blood Pressure 
As per standard of care (at least once per day) 
Events (e.g. door open for 
feeding, care, baby removed for 
cuddles) 
For each event record start and end time, type of 
activity, number of portholes/door open, any 
error/alarms 
on 
the 
incubators 
and 
any 
comments. 
Each incubator will be individually identified by serial number for reference in CRFs, 
source documents (medical record/chart) and on cleaning logs. The randomisation 
details and the identification number of the incubators used will be recorded when the 
subject put into the first incubator; likewise, at the 24 hours cross-over point. 
Further details about the mOm incubator can be found in the Investigator brochure 
(IB) filed in the ISF.  For the incubator, hourly temperature readings from the digital 
display, time to set up, time to clean, types of cleaning performed and reasons/times 
when incubator opened to administer to baby’s care will be recorded.  
Any unanticipated Adverse Events of the baby, or of the incubator functionality, or 
usability (e.g. malfunction or rainout), will also be recorded on the CRF, AE log in the 
ISF and in the patient notes. 
In addition, the views of staff will be collected through completion of a questionnaire 
about the baby’s comfort, visibility, ease of care, usability, ease to set up, ease of 

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cleaning and acceptability, one for each incubator type, per staff member involved in 
the study activities. 
6.3  
Inclusion / Exclusion Criteria 
6.3.1 Inclusion criteria 
The subject must satisfy all the following criteria to be eligible for the study: 
x Parent/legal guardian is willing and able to give informed written consent for 
participation of their baby in the study. 
x Parent/legal guardian is aged 16 years or above. 
x Subject has spent at least a day (24 hours) in a standard incubator. 
x Subject considered clinically stable from a cardio-respiratory point of view. 
x Subject requires incubator care but does not require additional humidification. 
x Subject requires incubator care for at least 48 hours. 
x Subject is at least 30 weeks gestational age. 
x Subject is less than or equal to 6kg in weight. 
6.3.2 Exclusion Criteria 
The subject may not enter the study if, in the opinion of the Investigator, or delegee 
taking consent, ANY of the following apply: 
x Parent/legal guardian with learning disabilities or mental illness and is considered 
unable to give informed consent. 
x Parent/legal guardian is a prisoner and young offender. 
x Parent/legal guardian is considered to have a particularly dependent relationship 
with the investigator(s).  
x Parent/legal guardian is deemed to belong to a vulnerable group. 
x Subject has major congenital abnormalities. 
x Subject has temperature instability, defined as being outside of a normal range 
based on each infant’s individual characteristics.  
x Attending clinician and/or nursing concern regarding clinical stability of the infant 
(e.g. infection suspected). 
6.4 
Withdrawal of Patients from the study 
All subjects (via their parent/legal guardian) are free to withdraw from the study at any 
time for any reason without their standard of care being affected.  If a patient is 
withdrawn before the completion of this study, the reason(s) for withdrawal will be 
documented where possible.  
Withdrawal of a subject by a member of the clinical research team will occur for any 
of the following reasons: 
x An unanticipated serious adverse event (e.g. SAE or SADE) which requires 
immediate change to alternative treatment. 
x A protocol violation (i.e. violation of the inclusion/exclusion criteria during 
screening period or serious deviation from the clinical investigation plan, or 
guidelines during the study which may affect the integrity of the study or the 
patient’s well-being). 

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7.
ADVERSE EVENTS
7.1 
Adverse event (AE)
Any undesirable clinical occurrence in a subject, whether considered to be procedure 
related or not, that includes a clinical sign or symptom. Typical AEs which should be 
recorded include but are not limited to: skin injury or infection, pressure sores, 
hyperthermia, hypothermia, apnea and brachycardia.  AEs also include Adverse 
Device Events (ADEs). ADEs are any undesirable device related event, whether 
clinically relevant to the subject or not.  Typical device ADEs which should be 
recorded include but are not limited to: rainout, practical access issues, degradation 
of part the incubator, inadvertent displacement of lines thought to be due to the 
design of the incubator. 
AEs will be recorded from the time the subject has been enrolled and placed in the 
first incubator type until the end of their participation in the study (i.e. after 48 hours 
incubation is complete), unless a device related adverse event is on-going in which 
case it will be monitored until resolved.  All AEs should be recorded in the patient 
notes, the CRF and on the Adverse Event log in the ISF. 7.2  Anticipated Adverse 
Event 
Any undesirable clinical occurrence in a subject that may be expected to occur during 
routine care.  These will not be reported unless thought to be study related.   
Anticipated adverse events may include but are not limited to: 
x Reflux 
x Wind 
x Nappy rash 
x Crying 
7.3 
Serious Adverse Events 
Serious Adverse Event (SAE) or Serious Adverse Device Event (SADE) any 
adverse medical or occurrence that: 
1. Led to a death.
2. Led to a serious deterioration in health of a subject that:
x Resulted a life-threatening illness or injury. 
x Resulted in a permanent impairment of body function or permanent 
damage to a body structure. 
x Resulted in an increased length of existing hospitalisation. 
x Resulted in requiring medical or surgical intervention to prevent 
permanent impairment of a body structure or a body function. 
3. Might have led to death or a serious deterioration in health had suitable action or
intervention not taken place.
7.4 
Reporting of Adverse Events 
All SAEs / SADEs must be reported by the Investigator to the Sponsor within 24 hours 
of learning of the incident, by the completion and emailing of an SAE report form, a 
copy of which will be available in the ISF.  Notification of the SAE should be made by 
phone/email, then the SAE form emailed even if not entirely complete, within the 24-
hour period of awareness.   

 
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The Sponsor will then liaise with the Chief Investigator and report the SAE to the REC, 
and the NHS Trust Risk reporting mechanisms (Datix).  If deemed possibly device 
related, it will also be reported to the MHRA and the other PIs and SIs involved in the 
study.   
 
All adverse events including AEs, ADEs, SAEs and SADEs which occur during the 
participation in the clinical study must also be recorded in the patient’s notes and on 
the Adverse Event log within 10 working days and will be tracked by the Sponsor 
representative through regular site monitoring. 
 
Severity of AEs must be identified.  Table 2 provides definitions to be used to assess 
AEs. 
 
TABLE 2:  DEFINITIONS OF SEVERITY FOR ADVERSE EVENTS 
Mild: 
Symptom is only slightly noticeable to the subject or does not cause 
discomfort; does not negatively influence functioning; prescription drugs 
not required for relief of symptom but may be prescribed. 
Moderate: 
Symptom is of a sufficient severity to cause discomfort; performance 
of daily activities is negatively influenced; treatment for symptom 
may be needed. 
Severe: 
Symptom causes severe discomfort and incapacitation having 
significant impact on the subject’s performance of daily activities; 
treatment for symptom may be given and/or subject’s hospitalization 
may be extended. 
Life 
Threatening: 
An event that places the subject at immediate risk of death from the 
event. 
Fatal: 
An event that was the direct cause of the subject’s death. 
 “Severe”, “Life-Threatening” or “Fatal” AEs that are determined to be “causally 
related” to the procedure are to be reported to the Sponsor within 24 hours of the 
site’s knowledge of the event (See definition in Table 3). 
TABLE 3:  DEFINITIONS OF RELATIONSHIP OF ADVERSE EVENTS 
Not related: 
Relationship to the device, comparator or procedures can be 
excluded when: 
x the event has no temporal relationship with the use of 
the investigational device, or the procedures related to 
application of the investigational device 
x the serious adverse event does not follow a known 
response pattern to the medical device (if the response 

 
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pattern is previously known) and is biologically 
implausible; 
x the discontinuation of medical device application or the 
reduction of the level of activation/exposure - when 
clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not 
impact on the serious adverse event; 
x the event involves a body-site or an organ that cannot 
be affected by the device or procedure; 
x the serious adverse event can be attributed to another 
cause (e.g. an underlying or concurrent illness/ clinical 
condition, an effect of another device, drug, treatment 
or other risk factors); 
x the event does not depend on a false result given by 
the investigational device used for diagnosis9, when 
applicable; 
In order to establish the non-relatedness, not all the criteria 
listed above might be met at the same time, depending on the 
type of device/procedures and the serious adverse event. 
Possible: 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, is weak but 
cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or 
treatment). Cases where relatedness cannot be assessed, or 
no information has been obtained should also be classified as 
possible. 
Probable: 
The relationship with the use of the investigational device or 
comparator, or the relationship with procedures, seems 
relevant and/or the event cannot be reasonably explained by 
another cause. 
 
Causal 
Relationship: 
The serious adverse event is associated with the 
investigational device, comparator or with procedures beyond 
reasonable doubt when: 
x the event is a known side effect of the product category 
the device belongs to or of similar devices and 
procedures; 
x the event has a temporal relationship with 
investigational device use/application or procedures; 
x the event involves a body-site or organ that 
o the investigational device or procedures are 
applied to 
o the investigational device or procedures have an 
effect on; 

 
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x the serious adverse event follows a known response 
pattern to the medical device (if the response pattern is 
previously known); 
x the discontinuation of medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse 
event (when clinically feasible); 
x other possible causes (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another 
device, drug or treatment) have been adequately ruled 
out; 
x harm to the subject is due to error in use; 
x the event depends on a false result given by the 
investigational device used for diagnosis, when 
applicable; 
In order to establish the relatedness, not all the criteria listed 
above might be met at the same time, depending on the type 
of device/procedures and the serious adverse event. 
 
 
 
 
 
 

 
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8. 
STATISTICS AND DATA ANALYSIS 
The primary endpoint is babies' truncal skin surface temperature variation; also termed 
core or central temperature. This is expected to fluctuate but remain within normal 
temperature limits (36.5 to 37.5 degrees Celsius).  Variations from this endpoint will 
be analysed and compared statistically between the two arms of the study. 
 
Thirty-six completed datasets are required for the analysis to be valid.  A complete 
subject dataset will be deemed acceptable if 19 of the 24, once-hourly temperature 
observations have been recorded for each incubator type (i.e. 79% compliance).  This 
degree of compliance was considered acceptable for analysis because it is still greater 
than the routine standard for this type of incubator care for clinically stable infants of 
30 weeks GA or greater, which is often every three hours.  Although data analysis will 
be largely descriptive, the performance of the mOm incubator will be statistically 
quantified by assessment of the fluctuations of babies' temperatures during each 24-
hour period.  It is expected that these babies' temperatures will fluctuate by around 
one degree Celsius, and this is normal.  Thus, analysis will explore whether 
fluctuations for each baby keep within this bound.  A 95% confidence interval will be 
calculated around the mean of these fluctuations within each baby for each of the two 
incubators.  Data from 36 babies would allow such a confidence interval to be 
calculated to within plus or minus 0.33 of a degree if the actual mean fluctuations are 
around one degree (i.e. as normally expected) and assuming a two-sided confidence 
interval. 
 
Each patient will serve as their own control.  The order of incubator type used for each 
of the two consecutive 24-hour periods of incubator care, and therefore which study 
arm the subject is recruited to, will be assigned randomly.  A Microsoft Excel random 
number generation system will be used to generate random numbers with which the 
arm of the study which the subject is to enter will be assigned.  Each assignment will 
be placed in an envelope attached to each CRF already numbered with a continuous 
series subject number. 
 
Baseline demographic factors of the study subjects will be summarised.  For 
continuous variables, such as weight, the mean, standard deviation, median and range 
will be presented.  For categorical variables, such as gender, the proportion of subjects 
in each category will be presented.  
 
All data will be analysed based on intention-to-treat. Statistical analysis will focus on 
babies' temperature fluctuations whilst in each of the two incubators.  Graphical 
displays of these, as well as summary statistics such as the variance of temperature 
throughout the two 24-hour periods will be presented.  A 95% confidence interval for 
the size of these temperature fluctuations for each incubator type will be calculated 
and this measure will be used to consider whether the mOm incubator works as well 
as the standard one in maintaining temperature control. Secondary outcome 
measures will be presented similarly. 
 
Questionnaire data will be summarised to assess usability and acceptability of the 
mOm incubator to the clinical research team (staff).     
 
 

 
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9. 
ETHICS 
9.1 
Declaration of Helsinki 
This study will be conducted according to the guidelines established in the Declaration 
of Helsinki7.  
 
Subjects will be free to withdraw from the study at any time without prejudice to their 
subsequent treatment.  In the instance of SADEs occurring the Sponsor and/or CI may 
decide to stop the study, with immediate effect, on grounds of patient safety at which 
point all subjects would move into the conventional standard care pathway.  
 
9.2 
Independent Ethics Committee Approval 
This study will be conducted according to a favourable opinion from [name to be 
inserted] Research Ethics Committee (REC), the MHRA, Health Research Authority 
(HRA) and hospital NHS R&D governance committee.  
 
9.3 
Informed Consent 
An appropriately trained member of the hospital registry study team, as indicated on 
the delegation of authority log by the CI/PI, will provide both written and verbal versions 
of the Participant information sheet (PIS) and Informed consent form (ICF) to the 
subject detailing no less than: the exact nature of the study; the implications and 
constraints of the CIP; and any risks involved in taking part.  It will be clearly stated that 
the parent/legal guardian is free to withdraw the subject from the study at any time for 
any reason without prejudice to future care, and with no obligation to give the reason 
for withdrawal. 
 
The subject will be allowed as much time as wished to consider the information, and 
the opportunity to question the Principal Investigator, their GP or other independent 
parties to decide whether they will participate in the study.  Written Informed Consent 
will then be obtained by means of subject dated signature and signature of the person 
who presented informed consent and only the investigator, or other appropriately 
trained person, identified by the CI/PI authorized to do so on the delegation of authority 
log.  A copy of the signed Informed Consent will be given to the subject, a copy placed 
in their medical notes and a third copy retained at the study site with the case report 
form.   
 
 
10. 
SUBJECT CONFIDENTIALITY 
The Investigator will ensure that the subject’s anonymity is maintained.  Unique 
anonymous subject numbers will be the sole identifiers used, and no personal or non-
anonymized data will leave the NHS Trust site.  All documents will be stored securely 
and kept in strict confidence in compliance with the Data Protection Act 1998 and the 
new General Data Protection Regulations (GDPR), May 2018.  
 
 
11. 
DATA MANAGEMENT 
The only confidential data obtained for the study will be retained securely within the 
department in the approved study site in a designated folder (Investigator Site File).  

 
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The enrolment log will contain the subjects’ name, hospital number, and date of birth, 
plus the date of consent and the allocated subject number which will identify the subject 
from then on.  Standard procedures for handling and processing records will adhere to 
GCP and mOm Incubators Ltd SOPs. 
 
11.1 Data Quality Assurance 
Steps will be taken to ensure that the accuracy and reliability of data by the selection 
of qualified study sites, review of the study CIP procedures with the study site staff prior 
the study start, in addition to monitoring visits by a mOm Incubator Ltd representative 
(Project manager or appropriately trained CRA). All study related data will be reviewed 
for accuracy (where possible) and completeness and adherence to be CIP, as detailed 
in the monitoring plan.  All identified discrepancies (protocol deviations) will be reported 
in the monitoring visit report, as a note to file in the ISF, discussed and resolved with 
the investigator or his/her delegated staff. A protocol deviation will be considered a 
protocol violation if it affects subject or public safety, or the integrity of the study. All 
protocol violations relating to public /subject health and safety will be reported to the 
REC and MHRA. 
 
Persistent or serious non-compliance of an Investigator may require the Investigator 
to be disqualified from the Clinical Study. 
 
11.2 Data Storage at the end of the study 
All data removed from the study site(s) will be anonymized and will be retained such 
that it may be disseminated via publication for the public interest and for advancement 
of science as discussed in section 14.  The confidential data would be retained at the 
end of the study for the period of time deemed suitable by the competent authority and 
specified within the standards governing clinical trials9.  A certificate of destruction will 
be produced to confirm destruction.  The records/data will be held for 15 years by the 
Sponsor and by each site according to hospital policy which can be 15 or 20 years.  
The exception is for data already published in the public domain which cannot be 
destroyed. 
 
Data will be extracted manually from the medical notes and print outs from hospital 
based electronic systems and entered into an appropriately designed data collection 
form (CRF and study-specific logs).  All personal data will be entered into a study 
specific database by the Sponsor where the data is to be analysed and held.  Clinical 
data will be stored on a secure server with access restricted to appropriate personnel.  
Storage is on a restricted area of a file server.  Authorization to access the restricted 
area of the file server is strictly limited.  Data will be processed on a workstation by 
authorized staff.  The workstations access the network via a log in name and password. 
Furthermore, all results are anonymized before analysis, and researchers will not be 
able to link specific results to individuals. 
 
The study site Investigator will ensure that personal information is kept 
confidential.  The NHS trust will be responsible for archiving the Investigator Site File 
including a copy of the CRFs for a period of 15 years.  If they are moved from NHS 
Trust property or need to be destroyed beforehand this may be done only with written 
permission of the Sponsor. 
 

 
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12. 
FINANCING AND INSURANCE/INDEMNITY 
The financing for the study will come from the Sponsor company, ‘mOm Incubators 
Limited’.  No payment will be made to study subjects. Appropriate insurance/indemnity 
will be provided by the Sponsor. 
 
 
13. 
CLINICAL SUPPLIES 
The Sponsor will supply all mOm incubators to be used in the clinical study and provide 
all necessary clinical study related documents such as, CRFs, staff questionnaires, 
study-related incubator cleaning logs and an Investigator Site File containing all of the 
other regulatory documents, study logs (screening, enrolment, delegation of authority 
and AE logs) which need completing, all study manuals, records of training and 
contracts, plus any other study related documentation. 
The hospital will supply access to their standard incubators, routine incubator cleaning 
materials and standard source documents such as patient charts, monitor downloads, 
medical records. 
 
 
14. 
REPORTING AND DISSEMINATION OF STUDY OUTCOMES 
In the interests of science, salient positive or negative results shall be published in a 
manner that is timely, however allowing for the commercial progress of the company 
(e.g. sensitive to any patent filings or company proceedings).  Information may be 
disseminated by means of journal publication, poster presentations, public databases 
(such as Clinicaltrials.gov), and presentations at conferences relevant to the fields of 
Neonatology, Medical Devices and Fetal Medicine.  
 
Photographs/video recordings of the use of the mOm incubator taken during the study 
and data collected will be anonymized to prevent identification of the subject and 
photographs/video recordings will be taken in a way so that my baby cannot be 
identified.  The data/photographs/video taken may be used for teaching of medical 
healthcare staff and students, both in the UK and abroad, and may be used in 
marketing materials (including online resources) which may be seen by the public.  
Although consent can be withdrawn from the study at any time, but 
photographs/video/data that have already been published cannot be withdrawn. 
 
The Investigator may not publish or present study data without the written permission 
and review of the Sponsor. 
 
 
15. 
REFERENCES 
(1) Glass L, Silverman WA, Sinclair JC. Relationship of thermal environment and 
caloric intake to growth and resting metabolism in the late neonatal period. Biology 
of the Neonate 1969;13:324-40 
 

 
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(2) Hey EN, O'Connell B. Oxygen consumption and heat balance in the cot-nursed 
baby. Archives of Disease in Childhood 1970;45:335-43 
 
(3) Knobel R, Holditch-Davis D. Thermoregulation and heat loss prevention after birth 
and during neonatal intensive-care unit stabilization of extremely low-birthweight 
infants. J Obstet Gynecol Neonatal Nurs. 2007 May-Jun; 36(3):280-7 
 
(4) Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited 
environments. J Perinatol. 2012 May; 32(5):317-24 
 
(5) BS EN 60601-2-19. 2009+A1:2016. Medical Electric Equipment. Part 2-19: 
Particular requirements for the basic safety and essential performance of infant 
incubators (IEC 60601-2-19:2009). The British Standards Institutions 2017. 
 
(6) BS EN ISO 10993-1. Biological Evaluation of Medical Devices. Part 1: Evaluation 
and Testing (ISO 10993-1:2003). June 2009, incorporating corrigendum April 
2010. 
 
(7) Declaration of Helsinki. Medical Research Involving Human Subjects. World 
Medical Association. Adopted 1964, amended 2013. 64th WMA General 
Assembly, Fortaleza, Brazil, October 2013 
 
(8) BS EN ISO 14155:2011. Clinical Investigation of Medical Devices for Human 
Subjects – Good Clinical Practice (ISO 14155:2011). BSI 2011. 
 
(9) 2005/28/EC. Laying down principles and detailed guidelines for good clinical 
practice as regards investigational medicinal products for human use, as well as 
the requirements for authorisation of the manufacturing or importation of such 
product. Official Journal of the European Union, 8 April 2005. 
(10) 
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices 
under the Regulation (EU) 2017/745. 
 
 

 
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16. 
INVESTIGATOR APPROVAL STATEMENT 
 
TITLE: COMPARISON OF THE MOM INCUBATOR WITH A STANDARD 
INCUBATOR FOR THE MAINTENANCE OF THERMAL STABILITY IN 
INFANTS (6KG)  
(ALSO KNOWN AS THE MOM INCUBATOR PILOT STUDY) 
 
CIP REF: MOM/2018/01  
VERSION 3.0, DATED 08 MARCH 2022 
 
IRAS Ref: 224546 
 
Clinicaltrials.gov: NCT03450668 
 
I have read this Clinical Investigation Plan and agree to conduct this study as outlined 
within. 
I acknowledge that it is my responsibility that all study staff members have read and 
understand all aspects of this Clinical Investigation Plan. 
I agree to fully collaborate with mOm Incubators Limited during the conduct of this 
study. 
I will adhere to this Clinical Investigation Plan, all applicable regulations and guidelines 
pertaining to clinical investigation of medical devices during as well as after completion 
of this study. 
 
Investigator: 
Printed Name: 
 
 
 
 
 
 
 
Position: 
 
 
 
 
 
 
 
Study Function: 
 
 
 
 
 
 
Signature: 
 
 
 
 
 
 
 
 
Date: