The AIRTiME Study: Assessing Infant Respirations and Tidal-volume with Manometry Evaluation, an observational, prospective cohort study

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.