Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000842460
Ethics application status
Approved
Date submitted
8/07/2025
Date registered
5/08/2025
Date last updated
5/08/2025
Date data sharing statement initially provided
5/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The AIRTiME Study: Assessing Infant Respirations and Tidal-volume with Manometry Evaluation, an observational, prospective cohort study
Scientific title
AIRTiME: Assessing Infant Respirations and Tidal-volume with Manometry Evaluation, an observational, prospective cohort study
Secondary ID [1] 314840 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Complications of newborn 338107 0
Respiratory Difficulties 338108 0
Premature Infants 338109 0
Condition category
Condition code
Reproductive Health and Childbirth 334405 334405 0 0
Complications of newborn
Respiratory 334406 334406 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Newborn infants who have parental consent provided and who are clinically stable at the time of assessment will be included in the study. Monash Nest houses 64 fully staffed cots between two Neonatal Intensive Care Units (NICU)s and two Special Care Nurseries (SCN). While some babies admitted in the unit will be ineligible to receive facemask continuous positive airway pressure (CPAP) or be included in the study, we anticipate that recruitment and data collection will be completed in less than 6 months. Informed consent will be gained from each parent of infants in the study using the attached information and consent form.
Routine cares for infants will be provided by highly skilled nurses in the NICU who have also received NeoResus training, based upon Australian New Zealand Committee On Resuscitation (ANZCOR) resuscitation guidelines. Following earlier informed consent from parents, a member of the research team will be present at the routine care. The research team member will ensure that verbal consent has been obtained from the bedside nurse prior to conducting the study. This will allow the nurse to raise any concerns or objections to the infant being enrolled in the study and will ensure optimal timing. The clinical care of the infant during this study is paramount and the study will be discontinued at any time if it is thought to pose a risk to the infant.
Infants who are receiving nasal CPAP require a period of face mask CPAP while switching interfaces between single nasal prong or FlexiTrunk system (Fischer and Paykel, Auckland New Zealand). Therefore, the recording will take place at this time. A video recording device (GoPro Hero 12, California, USA) will be attached to the top of the cot, ensuring that the field of view includes the infant and the manometer. A portable respiratory function monitor (NM3, Respironics, Murrysville, USA) will be plugged into the cot to get accurate tidal volume measurements which will be downloaded onto a USB drive. A second camera will be focused at the NM3 monitor. During routine cares of the infants, face mask CPAP will be applied for 1-2 minutes. In infants who are already receiving nasal CPAP, no changes will be made to the settings that the infant is currently on. It is routine care for infants being moved from one CPAP interface to another to have available a brief period of face-mask CPAP as they are being changed. Infants who are receiving high-flow oxygen supplementation and have parental consent will receive a brief period of mask CPAP. The positive end expiratory pressure (PEEP) set on CPAP will be that of their flow rate received via high flow nasal cannulae (HFNC), as Liew et al. demonstrated equivalence between the two within the values of 2-8 cm 3 of PEEP flow, which infants in the study will be on. Video recording will commence and will conclude after one to two minutes. The face mask CPAP will be changed back to routine CPAP (nasal route) or HFNC and care will be completed according to Monash Health guidelines. Data collection for each participant will be 1-2 minutes with no follow-up planned currently. Data will be stored on a secure Monash Health database and does not require de- identification.
If, during the study, the infant requires higher levels of FiO2 , this will be titrated and increased to a maximum of 0.5. If oxygen requirements are higher than 0.5, the study will be ceased, and the infant will be stabilised. Likewise, if the infant has an apnoeic episode that does not respond to stimulation, intermittent positive pressure ventilation (IPPV) will be commenced, and the data collection will be abandoned.
Intervention code [1] 331446 0
Not applicable
Comparator / control treatment
No control group as observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342096 0
amplitude of manometer needle swinging during spontaneous breathing
Timepoint [1] 342096 0
One 2 minute video will be recorded during care of the infant and this will be used to analyse the primary outcome.
Primary outcome [2] 342097 0
To determine the accuracy of manometer movement (MM )in predicting tidal volumes of infants receiving CPAP who weigh >1500g
Timepoint [2] 342097 0
At time of care of infant during 2 minute video.
Primary outcome [3] 342198 0
measured tidal volume (Vt) in infants receiving face-mask continuous positive airway pressure (CPAP)
Timepoint [3] 342198 0
One 2 minute video will be recorded during care of the infant and this will be used to analyse the primary outcome.
Secondary outcome [1] 449573 0
Measuring manometer movement (MM) and end-tidal CO2
Timepoint [1] 449573 0
Video taken at point of care with 2 minute video recording.
Secondary outcome [2] 449574 0
observing chest wall movement during spontaneous respiration of infants
Timepoint [2] 449574 0
At time of care of infant during 2 minute video.
Secondary outcome [3] 450654 0
To determine the accuracy of manometer movement (MM )in predicting tidal volumes of infants receiving CPAP who weigh <1500g
Timepoint [3] 450654 0
At time of care of infant during 2 minute video.

Eligibility
Key inclusion criteria
Infants admitted to Monash NICU or SCN who are receiving CPAP respiratory support.
Has a legally acceptable representative capable of understanding the informed consent
document and providing consent on the participant’s behalf.
Infants on CPAP pressure between 5-8cmH 2 O and not predicted to require further surfactant.
Minimum age
No limit
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infants requiring invasive ventilation or nasal intermittent minute ventilation will be excluded
from the study.
- Infants requiring >0.3 FiO 2 to maintain SpO 2 >90%.
- Infants that have any anatomical contraindication to 2 minutes of fCPAP will be excluded from the study.
- Infants with conditions limiting their expected tidal volume based on their weight.
- Infants who have not had parental consent to participate, or whose parents have withdrawn
consent will be excluded from the study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For each infant, we aim to collect 20 high-quality breaths for analysis, leading to a total dataset of approximately 900 breaths. To ensure robust comparisons, we will analyse the average values of manometer amplitude (cmH2O) and tidal volume (ml/kg) across each infant’s 20 breaths.

Interrater reliability will be used to objectively study they amplitude of manometer movement. Three investigators on the team will watch 20 second clips of 15 videos and independently score the average manometer swing measured in centimetres of water. We will compare the calculated average using a Spearman rank-order test.

To determine our primary outcome, we will adopt mixed-effects models to evaluate the accuracy of MM in predicting Vt in infants on CPAP or HFNC. Mixed models will account for repeated measures (multiple breaths per infant) and random effects of individual infants, providing a more comprehensive analysis than simple correlation. Statistical significance will be assessed using a two-tailed p-value, with a threshold of p < 0.05 indicating statistical significance. A strong positive correlation (r > 0.7) would support our hypothesis that larger manometer swings correspond to greater tidal volumes. Conversely, a weak or non-significant correlation would suggest that manometer amplitude may not reliably predict tidal volume in this population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/08/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2026
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28191 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 44403 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 319398 0
Self funded/Unfunded
Name [1] 319398 0
Country [1] 319398 0
Australia
Primary sponsor type
Individual
Name
Dr Douglas Blank, Monash Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 321885 0
None
Name [1] 321885 0
Address [1] 321885 0
Country [1] 321885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317972 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317972 0
Ethics committee country [1] 317972 0
Australia
Date submitted for ethics approval [1] 317972 0
18/03/2025
Approval date [1] 317972 0
26/06/2025
Ethics approval number [1] 317972 0

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

Contacts
Principal investigator
Name 142738 0
Dr Douglas Blank
Address 142738 0
Monash Newborn, Monash Children's Hospital, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 142738 0
Australia
Phone 142738 0
+61 03 8572 3933
Fax 142738 0
Email 142738 0
[email protected]
Contact person for public queries
Name 142739 0
Douglas Blank
Address 142739 0
Monash Newborn, Monash Children's Hospital, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 142739 0
Australia
Phone 142739 0
+61 03 8572 3933
Fax 142739 0
Email 142739 0
[email protected]
Contact person for scientific queries
Name 142740 0
Douglas Blank
Address 142740 0
Monash Newborn, Monash Children's Hospital, Level 5, 246 Clayton Road, Clayton, VIC, 3168
Country 142740 0
Australia
Phone 142740 0
+61 03 8572 3933
Fax 142740 0
Email 142740 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval2025, HREC   RES-25-0000-063A - HREC Review Only Approval Letter (2).pdf
Study protocol2025, v3   19.07.2025 AIRTiME Study Protocol for HREC Application .docx
Informed consent form2025, v3   2025.07.19 AIRTIME PICF.docx


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.