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The Neonatal Ventilation using Tomography (NEOVENT) Study

The Neonatal Ventilation registry using Tomography (NEOVENT) Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000092594
Acronym
NEOVENT Study
Enrollment
300
Registered
2024-02-01
Start date
2024-08-12
Completion date
2029-02-28
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Respiratory disease is the most common reason for admission to a NICU. Unfortunately, our understanding of how many respiratory therapies used in the NICU help babies lungs is poor. Broadly, we will create a large registry of lung function data during common NICU respiratory events and diseases. By doing so we will be able to address some of the uncertainties in clinical care for babies born with respiratory failure, specifically how best to determine optimal levels of respiratory support and how to guide common respiratory interventions such as extubation and surfactant therapy. We hypothesise that by generating a greater understanding of the relationship between a baby's lung disease and NICU respiratory care we will provide the tools to allow clinicians to improve respiratory care.

Interventions

Neonates born between 22+0 weeks’ gestation and term gestation admitted to a participating centre needing assisted respiratory support for any cause of respiratory failure in whom prospective parental informed consent can be obtained will be considered eligible. Measurements of lung function will be made using electrical impedance tomography (EIT) at different times in their neonatal intensive care journey. These measurements will be made over 30-60 min of stable respiratory support after any ch

Neonates born between 22+0 weeks’ gestation and term gestation admitted to a participating centre needing assisted respiratory support for any cause of respiratory failure in whom prospective parental informed consent can be obtained will be considered eligible. Measurements of lung function will be made using electrical impedance tomography (EIT) at different times in their neonatal intensive care journey. These measurements will be made over 30-60 min of stable respiratory support after any change in mode or type of respiratory support and during procedures and treatments likely to alter respiratory function (surfactant therapy, extubation and intubation). For neonates requiring an anticipated NICU course of 4 or more weeks, weekly assessment of lung function will be made. The maximum duration of observation (EIT imaging) will be until birth or 36 weeks corrected post-menstrual age whichever is longest.

Sponsors

Murdoch Children's Research Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
0 to 14 Weeks
Healthy volunteers
No

Inclusion criteria

Neonates will be considered eligible for the study if they meet all of the following criteria: 1. Born between 22+0 weeks’ gestation and term gestation. 2. Receiving assisted respiratory support for any cause of respiratory failure at a participating NICU. 3. Parents or guardians able to provide written informed consent.

Exclusion criteria

Participants meeting any of the following criteria will be excluded from this study: 1. Any neonate whom the clinical team request we do not study. 2. Neonates in whom the placement of EIT belt at the standard position (nipple level) would interfere with clinical care, such as wound dressings, surgical sites or chest drains. 3. Neonates with known or suspected skin disease (e.g. Epidermolysis Bullosa) or at risk of breeches to skin integrity from wearable monitoring devices. 4. Families from which informed written consent cannot be obtained.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026