RecruitingACTRN12622000250730

A first in human study for a new resuscitation monitor for newborn babies requiring resuscitation at birth

Feasibility study of a novel resuscitation monitoring system for measuring mask leak and tidal volumes during neonatal resuscitation

Sponsor

ResusRight Pty Ltd

Enrollment

30 participants

Start Date

Oct 17, 2022

Study Type

Interventional

Conditions

Neonates requiring resuscitation with manual positive pressure ventilation following birth.

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.

Eligibility

Sex: Both males and femalesMin Age: 0 Hourss

Plain Language Summary

Simplified for easier understanding

When newborn babies do not breathe well after birth, doctors and midwives need to help them breathe using a face mask — a process called positive pressure ventilation (PPV). Doing this effectively depends on getting a good seal between the mask and the baby's face, which can be difficult. The NEMO monitor is a new device designed to give real-time feedback to the clinician about how well the mask is sealing, potentially improving how effectively the baby is being helped to breathe. This first-in-human study will test whether the NEMO monitor is safe to use during actual baby resuscitations, having previously only been tested on training mannequins. Babies who need PPV at birth, and babies in the neonatal intensive care unit who need mask-assisted breathing before a breathing tube is placed, will be enrolled. Eligibility is for newborn babies born from 30 weeks gestation who need breathing support at birth, or babies from 26 weeks gestation in the NICU needing mask ventilation. Babies with serious birth abnormalities or where a senior resuscitator is unavailable are excluded. Clinician participants must be experienced neonatal medical officers who have completed specific NEMO training.

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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 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.

Locations(2)

Westmead Hospital - Westmead

NSW, Australia

Royal Hospital for Women - Randwick

NSW, Australia

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ACTRN12622000250730