Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000250730
Ethics application status
Approved
Date submitted
28/01/2022
Date registered
11/02/2022
Date last updated
22/11/2022
Date data sharing statement initially provided
11/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A first in human study for a new resuscitation monitor for newborn babies requiring resuscitation at birth
Scientific title
Feasibility study of a novel resuscitation monitoring system for measuring mask leak and tidal volumes during neonatal resuscitation
Secondary ID [1] 306301 0
Nil known
Universal Trial Number (UTN)
Trial acronym
The "NeMo" Resuscitation Study

The "Neonatal Monitoring" Resuscitation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonates requiring resuscitation with manual positive pressure ventilation following birth. 325058 0
Condition category
Condition code
Reproductive Health and Childbirth 322494 322494 0 0
Complications of newborn
Emergency medicine 322495 322495 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neonates requiring resuscitation at birth will be placed on the resuscitation bed with initial care provided by the clinical team in accordance with the ANZCOR neonatal resuscitation guidelines. The pulse oximeter sensor will be placed on the neonate’s right wrist before connecting it to the pulse oximeter by the clinical team. The T-piece infant resuscitator/self-inflating bag with the NEMO monitor attached will be used by the clinician resuscitator for manual PPV as indicated. For the purpose of this study, clinician resuscitators using the NEMO monitor will be Neonatal Intensive Care Unit (NICU) registrars or above who have successfully completed neonatal resuscitation training with the NEMO device. All treatment decisions will be made by the attending clinical team. During manual PPV, the NEMO will display tidal volume as a simple numerical figure, with one decimal place when the volume is below 10 mL to provide extra information when dealing with extremely low birth-weight neonates. Mask leak will be measured in three ranges, 0-29% leak (low leak), 30-60% leak (moderate leak), and 61%-100% leak (high leak); but displayed in two (30-60% & 61%-100%) to enable the clinician to identify if they have substantial facemask leak that could be compromising resuscitation. Continuous recording of mask leak and tidal volumes during manual PPV will be recorded by the NEMO. The use of the NEMO monitor will be discontinued at the following events, whichever occurs first: The neonate is successfully stabilised and transitions off manual PPV; Endotracheal intubation; Insertion of Laryngeal mask airway; Admission to the Special Care Nursery/ NICU; At the request of the clinician resuscitator. Video recording and continuous cardiorespiratory monitoring (pulse oximetry and pulse rate) will be used to obtain and verify documentation of the neonatal resuscitations/manual PPV.

here are two groups of neonatal participants in this study.
Group 1 neonatal participants: Neonates who require resuscitation with manual PPV with a facemask immediately following birth.

Group 2 neonatal participants: Neonates who are admitted to the neonatal intensive care unit (NICU) and require manual PPV with a face mask as part a semi-elective/elective intubation procedure during their admission.

Note: There is no comparator group in this study.
Intervention code [1] 322729 0
Treatment: Devices
Comparator / control treatment
no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330282 0
Safety of the NEMO resuscitation monitor is the primary outcome for this study. It will be measured by determining the proportion of neonatal manual Positive Pressure Ventilation (PPV) cases that are successfully assisted with the NEMO resuscitation monitor. Data collected from the NEMO monitor, video recording, Massimo pulse oximeter, and the neonatal medical record will be used to assess the primary outcome.

Positive pressure ventilation will be defined as “successful” if all the following criteria are met: i. Device used as intended. ii. Device function as intended. iii. There are no serious neonatal adverse effects related to the use of the device during positive pressure ventilation. iv. There are no serious adverse device effects. Indications that the NEMO monitor was used as intended include: i. ANZCOR algorithm followed when using the NEMO monitor (Group 1 neonates). ii. NEMO monitor not prematurely removed. Indications that the NEMO monitor functioned as intended include: i. Device turns on and displays mask leak and tidal volume measurement during manual PPV. ii. No delay in the commencement or continuation of required PPV related to device use. iii. The NEMO monitor does not obstruct or distract the clinician’s assessment of the baby or PPV device. iv. Clinician adjusts mask seal based on displayed NEMO monitor data and further assessment shows this corresponds correctly with mask leak and patient response data (neonatal heart rate, SpO2). v. Clinician adjusts oxygen and ventilatory parameters based on displayed NEMO monitor data and further assessment shows this corresponds correctly with inflation and patient response data). Examples of serious neonatal adverse effects that will be monitored for include: i. Baby that is unable to be ventilated whilst the NEMO resuscitation monitor is in place. ii. Spontaneous pneumothorax related to the used of the device. Examples of serious device effects could include: i. NEMO monitor does not turn on. ii. NEMO monitor stops working mid-resuscitation. iii. NEMO monitor does not stay securely between mask and device. iv. Incorrect readings displayed. The primary outcome will be assessed by data collected from the NEMO monitor, video recording, Massimo pulse oximeter, and the neonatal medical record.
Timepoint [1] 330282 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Primary outcome [2] 330283 0
The NEMO Clinician Experience questionnaire.
Timepoint [2] 330283 0
60 minutes to 72 hours post PPV with the NEMO resuscitation monitor
Secondary outcome [1] 405554 0
Total duration of manual PPV. Data for this outcome will be collected from the NEMO monitor and the neonatal resuscitation record. Video recording the neonatal resuscitation will be used as a source of truth to confirm total duration.
Timepoint [1] 405554 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [2] 405555 0
Duration of moderate mask leak (defined as 30-60%) as proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor.
Timepoint [2] 405555 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [3] 405556 0
Duration of severe mask leak (defined as greater or equal to 61%) as proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor.
Timepoint [3] 405556 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [4] 405557 0
Tidal volume (mL/kg) administered until cessation of manual PPV and/or the admission to NICU (for group 1 neonates). Data for this outcome will be collected from the NEMO monitor. Birthweight will be collected from the neonatal resuscitation and/or birth record for Group 1 neonates. For group 2 neonatal participants, weight will be recorded from the neonatal record.
Timepoint [4] 405557 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [5] 405558 0
Duration of tidal volume between 4-8 mL/kg as proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor. Birthweight will be collected from the neonatal resuscitation and/or birth record for Group 1 neonates. For group 2 neonatal participants, weight will be recorded from the neonatal record.
Timepoint [5] 405558 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [6] 405559 0
Duration of inadequate tidal volume (defined as less than or equal to 3.9 mL/kg) as proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor. Birthweight will be collected from the neonatal resuscitation and/or birth record for Group 1 neonates. For group 2 neonatal participants, weight will be recorded from the neonatal record.
Timepoint [6] 405559 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [7] 405560 0
Duration of excessive tidal volume (greater or equal to 8.1 mL/kg) as proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor. Birthweight will be collected from the neonatal resuscitation and/or birth record for Group 1 neonates. For group 2 neonatal participants, weight will be recorded from the neonatal record.
Timepoint [7] 405560 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [8] 405561 0
Duration of airway obstruction (defined as <25th percentile measured of tidal volume with minimal leak during inflation) proportion of the time the face mask was used for manual PPV. Data for this outcome will be collected from the NEMO monitor.
Timepoint [8] 405561 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [9] 405562 0
Oxygen saturation (SpO2) until cessation of manual PPV and/or admission to NICU (group 1 participants). Data for this outcome will be collected from the Massimo pulse oximeter unit and neonatal resuscitation record.
Timepoint [9] 405562 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [10] 405563 0
Time to Spo2 >80% from birth. Data for this outcome will be collected from the Massimo pulse oximeter unit and neonatal resuscitation record (Group 1 participants only).
Timepoint [10] 405563 0
0 to 60 minutes of age (+/- 30 minutes)
Secondary outcome [11] 405564 0
Fraction of inspired Oxygen (FiO2) changes in the first 10 minutes of the neonate’s life. Data for this outcome will be obtained from the neonatal resuscitation record and the video recording of neonatal resuscitation (Group 1 participants only).
Timepoint [11] 405564 0
0 to 60 minutes of age (+/- 30 minutes)
Secondary outcome [12] 405565 0
Neonatal heart rate from birth/commencement of PPV until cessation of PPV and/or admission to NICU (group 1 participants only). Data for this outcome will be collected from the Massimo pulse oximeter unit and neonatal resuscitation record.
Timepoint [12] 405565 0
Neonatal group 1: 0 to 60 minutes of age (+/- 30 minutes) (from 30 weeks gestation)
Neonatal group 2: During elective/semi-elective intubation procedure in NICU (from 26 weeks gestation)
Secondary outcome [13] 405566 0
Adherence to ANZCOR neonatal resuscitation algorithm. Data for this outcome will be collected from the neonatal resuscitation record and the video recording of neonatal resuscitation (group 1 participants only).
Timepoint [13] 405566 0
0 to 60 minutes of age (+/- 30 minutes)
Secondary outcome [14] 405567 0
Neonatal death. Data for this outcome will be collected from the neonatal medical record.
Timepoint [14] 405567 0
Group 1 neonates: up to 30 days from birth
Group 2 neonates: up to 7 days following PPV procedure.
Secondary outcome [15] 405568 0
Intraventricular haemorrhage. Data for this outcome will be collected from the neonatal medical record.
Timepoint [15] 405568 0
up to 7 days from birth
Secondary outcome [16] 405569 0
Acute lung injury (e.g., pneumothorax). Data for this outcome will be collected from the neonatal medical record.
Timepoint [16] 405569 0
Group 1 neonates: up to 30 days from birth
Group 2 neonates: up to 7 days following PPV procedure.
Secondary outcome [17] 405570 0
Incidence of bronchopulmonary dysplasia (BPD) (if applicable). Data for this outcome will be collected from the neonatal medical record.
Timepoint [17] 405570 0
at 36 weeks corrected gestational age
Secondary outcome [18] 416057 0
Number of attempts at endotracheal intubation.
Timepoint [18] 416057 0
Group 1 neonates: 0-60 minutes following birth (+/-30minutes).
Group 2 neonates: During semi elective/elective endotracheal intubation in NICU admission.

Eligibility
Key inclusion criteria
Neonatal participants: There are two groups of neonatal participants for this study.

Neonatal Group 1 - Resuscitation at birth
Neonates born from 30 weeks gestation that require manual positive pressure ventilation during resuscitation following birth will be recruited to the study.

Neonatal Group 2 - Neonatal Intensive Care Neonates
Neonates from 26 weeks gestation that are admitted to the NICU that require manual
positive pressure ventilation with a facemask during elective/semi-elective endotracheal
intubation during their NICU admission.

Clinician resuscitators: Medical officers will be eligible to participate if they fulfill all the following criteria:
i. Employed at the study site
ii. Neonatology Staff Specialist/Neonatal Fellow/neonatal registrar (with minimum 6 months NICU experience)
iii. Successfully attend resuscitation training with the NEMO resuscitation monitor.
Minimum age
0 Hours
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates will be excluded from the study if they meet the following exclusion criteria:
i.Born with a potentially lethal congenital abnormality.
ii.Acute, severe, fetal compromise indicating intrapartum still birth (e.g., cessation of fetal heart rate).
iii.Unavailability of independent senior resuscitator.
iv.Unavailability of research team.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There are two groups of neonatal participants in this study that will receive the same intervention at different time points. There are no comparator groups in this study.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A full statistical analysis plan will be prepared prior to inspection of any data by the biostatistician. The analysis plan will provide full details on definitions of populations for analysis together with planned methods for presentation of data summaries.
Continuous variables (such as age) will be summarised using descriptive statistics (n (the number of observations), mean, median, standard deviation (SD), minimum and maximum). Categorical variables (such as sex) will be summarised using frequency tables (presenting frequencies and percentages).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/10/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21577 0
Westmead Hospital - Westmead
Recruitment hospital [2] 21578 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 36497 0
2145 - Westmead
Recruitment postcode(s) [2] 36498 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 310645 0
Commercial sector/Industry
Name [1] 310645 0
ResusRight Pty Ltd
Country [1] 310645 0
Australia
Funding source category [2] 310648 0
Government body
Name [2] 310648 0
Commonwealth of Australia under the BioMedTech Horizons (BMTH) program 4.0
Country [2] 310648 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResusRight Pty Ltd
Address
Sydney Knowledge Hub - Level 2,
Merewether Building,
Butlin Avenue,
Darlington, NSW 2006
Country
Australia
Secondary sponsor category [1] 311858 0
None
Name [1] 311858 0
Address [1] 311858 0
Country [1] 311858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310242 0
Sydney Children's Hospital Network HREC
Ethics committee address [1] 310242 0
Ethics committee country [1] 310242 0
Australia
Date submitted for ethics approval [1] 310242 0
28/03/2022
Approval date [1] 310242 0
19/05/2022
Ethics approval number [1] 310242 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116974 0
Dr Archana Priyadarshi
Address 116974 0
Neonatal Intensive Care Unit
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd,
Westmead NSW 2145
Country 116974 0
Australia
Phone 116974 0
+61 2 9845 2715
Fax 116974 0
Email 116974 0
[email protected]
Contact person for public queries
Name 116975 0
Matt Boustred
Address 116975 0
ResusRight Pty Ltd
Sydney Knowledge Hub
Level 2, Merewether Building,
Butlin Avenue, Darlington,
NSW 2006
Country 116975 0
Australia
Phone 116975 0
+61 0401164019
Fax 116975 0
Email 116975 0
[email protected]
Contact person for scientific queries
Name 116976 0
Matt Boustred
Address 116976 0
ResusRight Pty Ltd
Sydney Knowledge Hub
Level 2, Merewether Building,
Butlin Avenue, Darlington,
NSW 2006
Country 116976 0
Australia
Phone 116976 0
+61 0401164019
Fax 116976 0
Email 116976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.