None listed
Conditions
Brief summary
The “NEMO” resuscitation monitor has been designed to fill a current gap in respiratory monitoring need during resuscitation of babies at birth. The purpose of the NEMO is to provide immediate feedback on mask seal and technique to clinicians during resuscitation where manual positive pressure ventilation (PPV) is performed. It is hypothesised that this will improve the effectiveness of manual PPV, helping to improve short- and long-term health outcomes for babies who require resuscitation at birth. The NEMO is a new medical device that currently has only been used during training on manikins. This study aims to investigate the safety and acceptability of the NEMO resuscitation monitor for babies who require resuscitation with manual PPV following birth.
Interventions
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
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.
Sponsors
ResusRight Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed